Thoracic Surgery Trials

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Thoracic Oncology: Open Trials


Lung Cancer: Stage I
A Phase III study of adjuvant chemotherapy after resection of Stage 1(T2N0M0) non-small cell lung cancer 

VATS lobectomy: A feasibility study 

Lung Cancer: Stage I + II
Phase II prospective randomized study of adjuvant chemotherapy in completely resected Stage I (T2N0M0) and II non-small cell lung cancer with a companion tumor marker evaluation (BR10)

Randomized trial of mediastinal lymph node sampling versus complete lymphadenectomy during pulmonary resection in the patient with N0 or N1 (less than hilar) non-small cell carcinoma

The utility of PET in staging of patients with potentially operable non-small cell lung carcinoma

Phase I study of decitabine-mediated induction of tumor antigen and tumor suppressor gene expression in lung cancer patients

Lung Cancer: Stage II + IIIa
A phase III comparison between concurrent chemotherapy plus radiotherapy, and concurrent chemotherapy plus radiotherapy followed by surgical resection for stage IIIa (N2) non-small cell lung cancer

Pre-resection minimally invasive surgical restaging of Stage III (mediastinal node positive) non-small cell lung cancer 

A prospective study of the prognostic significance of occult metastases in the patient with resectable non-small cell lung carcinoma 

Lung Cancer: Stage Ib,II, IIIa 
Intergroup S9900: A Randomized Phase III trial of preoperative chemotherapy (paclitaxel + carboplatin) + surgery versus surgery alone in patients with early stage or resectable NSCLC 

Metastatic Disease
Phase I study of isolated lung perfusion with paclitazel and moderate hyperthermia in patients with unresectable pulmonary malignancies 

Thoracic Oncology: Closed Trials 

Lung Cancer: Stage I
Phase III double-blind randomized trial of 13-cis retinoic acid (13-CRA) to prevent second primary tumors in Stage I non-small cell lung cancer Video assisted wedge resection (VAR) and radiotherapy for high risk T1 non-small cell lung cancer: A phase II study 

Lung Cancer: Stage II + IIIa 
Prospective randomized trial of postoperative adjuvant therapy in patients with completely resected stage II and stage IIIa non-small cell lung cancer 

Phase III trial of surgical resection and chemotherapy (carboplatin and taxol) with or without adjuvant radiotherapy for mediastinoscopy negative but thoracotomy positive N2 Stage IIIa non-small cell lung cancer 

Phase II intergroup trial for superior sulcus lung cancer(Pancoast tumor) with concurrent chemo-radiation as induction therapy 

Lung Cancer: Metastatic Disease & Malignant Pleural Effusion
Sclerosis of pleural effusions by talc thoracoscopy versus talc slurry: A Phase III Study

A prospective randomized trial of Bleomycin vs Doxycycline vs Talc for intrapleural treatment of malignant pleural effusion 

Randomized trial of Open vs VATS for pulmonary metastasis 

Lung Cancer: Thymoma
Phase II Study of VIP (Etoposide, Ifosfamide and Cisplatin)in the Treatment of Invasive Thymoma 

Lung Cancer: Esophageal Cancer
Thoracoscopic staging for esophageal cancer 

A prospective randomized phase III trial comparing trimodality therapy to surgery alone for esophageal cancer 

Emphysema: Open Trials

Lung Volume Reduction Surgery
Multicenter randomized clinical trial on Lung Volume Reduction Surgery

Canadian Lung Volume Reduction Study

In reverse alphabetical order all of the above are detailed below

VATS Lobectomy: A Feasibility Study

Originating Group

CALGB 39802

P.I.:

Participating Groups

Objectives

1. To determine the feasibility of performing VATS lobectomy in patients with small (<= 3cm.) peripheral non-small cell lung cancers, where feasibility is defined as the ability to carry out a lobectomy using a VATS approach without significant morbidity or peri-operative mortality.
2. To determine the rate at which a thoracotomy must be carried out to complete a VATS lobectomy.
3. To describe the complications associated with VATS lobectomy.
4. To describe the length of the operative procedure, the duration of chest tube stay, and length of hospitalization.
5. To describe the survival and failure-free survival, over a 5-year period, of patients with a small, peripheral non-small cell lung cancer who have had a VATS lobectomy.

Eligibility

1. Solitary peripheral (in the outer half of the lung field on radiograph), <=3cm. lung lesion.
2. Suspected or histologically documented non-small cell lung cancer (NSCLC)
3. No metastatic disease. If mediastinal lymph nodes are >1cm on pre-study chest CT, a mediastinoscopy (anterior, cervical or both) must be performed. If lymph nodes are positive at mediastinoscopy the patient is not eligible.
4. ECOG performance status 0-2.

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Comments

Thoracoscopic staging for esophageal cancer

Originating Group

CALGB 9380

Participating Groups

Objectives

1. To evaluate the feasibility, morbidity and mortality of preoperative staging thoracoscopy/laparoscopy for esophageal cancer
2. To assess the accuracy of lymph node staging by thoracoscopy/laparoscopy through comparison to final pathologic staging
3. To assess the benefit of thoracoscopy/laparoscopy when added to clinical staging
4. To assess the costs of throacoscopic/laparoscopic lymph node (TSLN/LSLN) staging and the possible savings of avoiding unnecessary esophagectomy

Eligibility

1. Histologically codumented squamous cell carcinoma or adenocarcinoma of the thoracic (below 20 cm) esophagusor geastroesophageal junction is required
2. No distant metastases or local invasion of adjacent structures
3. Suitable for thoracoscopy and laparoscopy
4. Age >= 18 years
5. Informed consent and IRB approval within one year
6. No prior chemotherapy or readiotherapy within past five years
7. Performance status 0-2
8. Evaluation by thoracic surgeon

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Comments

 

activated 2/95

closed 8/99

accrual goal of 136 patients reached

Publication: CALGB 9380: A Prospective Trial of the Feasibility of Thoracoscopy/Laparoscopy in Staging Esophageal Cancer. Krasna MJ, Reed CE, Newzwiecki D, et al. Ann Thorac Surg 2001;71:1073-79.

The utility of positron emission tomography (PET)in staging patients with potentially operable non-small cell carcinoma

Originating Group

ACSOG Z0050

Participating Groups

TBA

Objectives

This is a study of 2-FDG positron emission tomography (FDG-PET) staging in patients with suspected or histologically confirmed stage I, stage II, or stage IIIa (N2) non-small cell lung cancer (NSCLC) by clinical assessment and for whom precise staging is to be done in order to make a surgical decision regarding pulmonary resection.

1. Primary: To ascertain whether FDG-PET scanning can detect lesions that would preclude pulmonary resection in patients found to be surgical candidates by standard imaging precedures.
2. Secondary: To use the data collected to generate hypotheses to be used in future studies, such as which types of previously undetected lesions FDG-PET is best able to identify.

Eligibility Criteria

1. Patient has either strongly suspected, or histologically or cytologically confirmed, newly diagnosed, untreated, single lesion bronchogenic NSCLC (adenocarcinoma, non-lobar/non-diffuse bronchioloalveolar carcinoma,large cell carcinoma, or squamous cell carcinoma). Patient is eligible based upon mediastinal node histology diagnosed by transbronchial biopsy, and if a separate ipsilateral lung lesion is clearly evident on radiographs, biopsy of the lung tumor is not required for this patient.
2. Patient may be eligible without histologic or cytologic proof if 1) the patient is strongly suspected to have primary bronchogenic carcinoma (e.g. heavy smoker with a new peripheral mass with typical appearance of lung cancer on chest radiograph although bronchoscopy and/or fine needle aspiration is nondiagnostic); 2) tumor is clinically resectable; and 3) an exploratory thoracotomy is planned.
3. Patient must be medically fit for sugical staging procedures follwing the thoracic surgeon's evaluation of general medical fitness and pulmonary function, or be a candidate for resection of the clinical stage I, II, or IIIa lesion.
4. Patient must have completed the standard staging procedures: diagnostic imaging with chest x-ray, CT of chest, CT of upper abdomen to include adrenals, a bone scan, and a brian image (either CT with contrast or MRI), without evidence of Stage IIIb or IV disease.
5. Patient must have baseline alkaline phosphatase and calcium serum levels.
6. Patient must not have had a prior PET scan for evaluation of their NSCLC.
7. Patients must be able to tolerate PET, (i.e. not claustrophobic and able to lie supine for 1.5 hrs).
8. Patient must be 18 yrs of age or older.
9. Patient must not be pregnant. This is in order to avoid unnecessary fetal radiation exposure and because the optional use of furosemide is contraindicated in pregnancy. Pregnancy tests must be done if there is a possibility of pregnancy.
10. Patient who has controlled diabetes mellitus is eligible, as evidenced by a fasting blood glucose value <150mg/dL without administration of any diabetic medications to control glucose level.
11. A cancer survivor is eligible provided that the following criteria are met:(a) the patient has undergone potentially curative therapy for all prior malignancies,(b)there has been no evidence of any prior malignancies for at least five years (except for completely resected cervical or non-melanoma skin cancer), and (c) the patient is deemed by their treating physician to be at low risk for recurrene from prior malignancies.

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Comments

Opened to accrual 10/99

Sample size 120 patients for the first stage of the study.

A. SPONSOR

Blue Cross Blue Shield of Massachusetts (Tel. No. 1 800 214 0019)

B. PARTICIPATING HEALTH PLAN

Blue Cross Blue Shield of Massachusetts
Harvard Pilgrim Health Plan
Others: being negotiated

C. SUPPORTERS

U.S. Surgical Corp., BioVascular Co. GlaxoWellcome and The Thoracic Foundation granted the funds for the research component of OBEST.

D. PARTICIPATING CLINICAL SITES

1. Medical-Surgical Centers. Medical-Surgical Centers are designated to perform all screening and diagnostic procedures, pulmonary rehabilitation, LVRS, and follow-up studies.

   Medical-Surgical Center	Telephone Number
   Beth Israel-Deaconess Medical Center, Boston	617 632 8383
   Brigham and Women's Hospital, Boston	1 888 BWH LUNG
   Lahey-Hitchcock Clinic, Burlington	781 744 2777
   Massachusetts General Hospital, Boston	617 726 5801
   U. Mass-Memorial Hospitals, Worcester	508 793 6678

2. Satellite Consortium Centers. The Satellite Consortium Centers are designated to provide all screening and diagnostic procedures, pulmonary rehabilitation and follow-up studies but will not perform LVRS. It is anticipated that by participating in the activities of OBEST, the Consortium Center staff will gain sufficient expertise to perform LVRS independently and set up second generation OBEST Medical Surgical Centers, if and when the demand for LVRS increases. The following hospitals were selected as Satellite Consortium Centers:

   Satellite Consortium Center	Telephone Number
   Bay State Medical Center, Springfield	413 784 4470
   Boston Medical Center, Boston	617 638 7487
   North Shore Medical Center, Salem	978 741 1215 Ext. 4285
   St. Elizabeth's Medical Center, Boston.	617 789 3065

3. Satellite Pulmonary Rehabilitation Centers. In order to accommodate patients, who reside at an inconvenient distance from OBEST clinical sites, seven additional Pulmonary Rehabilitation facilities have been selected throughout the Commonwealth of Massachusetts. The staffs at these facilities received formal training in a pulmonary rehabilitation program standardized by OBEST.

E. STUDY OBJECTIVES

a. Primary Objectives.

1. To establish in selected patients with severe emphysema, whether six months after LVRS there is

   i. Improvement in Health-Related Quality of Life (HRQOL), when compared to the medical arm receiving only optimal medical management, as measured by the Chronic Respiratory Questionnaire (CRQ).

   ii. Improvement in functional capacity when compared to the medical arm receiving only optimal medical management, as measured by the six-minute walk test (6MWT).
   

2. To establish in selected patients with severe emphysema, whether the observed improvements, if any, following LVRS in HRQOL (as measured by he CRQ) and functional capacity (as measured by the 6MWT) persist for at least 3 years.

b. Secondary Objectives

1. To establish in selected patients with severe emphysema, whether compared to the medical arm receiving only optimal medical management, LVRS results in:

   i. improved physiologic measures of lung function, including arterial blood gases (ABG), FEV1, TLC, RV, and maximal inspiratory (Pi_max) and expiratory (Pe_max) pressures.

   ii. a reduction in dyspnea, as measured by the Baseline Dyspnea Index/ Transitional Dyspnea Index (BDI/TDI), the MRC Dyspnea Scale (MRC), and the Borg Visual Analog Scale (VAS).

   iii. improved overall quality of life, as measured by the Medical Outcomes Study Short Form-36 (SF-36).

2. To establish whether the observed improvements, if any, in physiologic measures of lung function, dyspnea and overall quality of life will persist for at least 3 years following randomization.
3. To establish whether radiographic assessment of lung heterogeneity correlate with benefits obtained from LVRS.

F. STUDY DESIGN

a. Randomized Clinical Trial. OBEST study design is based on a six-month randomization period between LVRS combined with the best available medical treatment versus the best available medical treatment alone. Six months after randomization both cohorts will be evaluated and patients in the medical arm will be permitted to crossover to surgery, if they so desire. The design affords access to LVRS by all suitable candidates and randomization merely determines the timing of the operation. As emphysema is a slowly progressing disease, the six-month wait for patients in the medical treatment arm is not fraught with undue risk of sudden or major untoward medical event. A total of 219 individuals will be randomized either to LVRS plus medical therapy or to medical therapy alone in a 2:1 ratio. Patients will be followed for 36 months after randomization. This period may be extended if warranted by study results.

b. Registry. OBEST Emphysema Registry (OER) will be used to observe the natural history of emphysema of the lung. It will enroll 160 patients, found ineligible for randomization by the OBEST screening process. For controls, 30 non-smoking and 30 smoking healthy adults will be recruited. This relatively uniform, closely monitored population will represent a unique resource for prospective longitudinal study of the natural history of emphysema.

G. ELIGIBILITY FOR THE RANDOMIZED CLINICAL TRIAL

Non-smoking individuals under the age of 75 with symptomatic emphysema and appropriate insurance coverage are screened for the randomized clinical trial. Those meeting eligibility criteria for the study will undergo six weeks of intensive pulmonary rehabilitation and then will be randomized between LVRS combined with optimal medical therapy and optimal medical therapy alone without LVRS.

H. DATA COORDINATING CENTER (DCC)

The DCC has collaborated on developing OBEST study design and study plan. The DCC also has primary role in data collection, storage and analysis, as well as training of On-site Research Coordinators. The group is staffed by scientists from Abt Associates and CareStat, Inc. Abt Associates is one of the largest economics, biostatistics and epidemiology research groups in the U.S. employing 800 professionals. The firm has had extensive experience with design and analysis of clinical trials and has collaborated with research organizations, academia, private industry and Government. CareStat, Inc, is a research firm specializing in clinical trials.

Comments

Opened to accrual 10/99

Sample size 120 patients for the first stage of the study.

Sclerosis of pleural effusions by talc thoracoscopy versus talc slurry: A Phase III study

Originating Group

CALGB 9334

Participating Groups

Objectives

1. To compare the proportion of patients with successful pleurodesis at 30 days after treatment for malignant pleural effusion (MPE) by talc slurry via chest tube or thoracoscopic talc insufflation
2. To compare the cost and cost-effectiveness of treating patients for MPE by talc slurry via chest tube to thoracoscopic talc insufflation
3. To compare the treatments with respect to the time to recurrence ofthe effusion, duration of chest tube drainage after sclerosis, extent of post-instillation complications and toxicities, ability to re-expand the lung, quality of life and pain experienced during treatment

Eligibility

1. History of malignant disease
2. Pleural effusion requiring sclerosis
3. Ability to undergo thoracoscopy under general anesthesia
4. Performance status 0-2
5. Age > 18 years and life expectancy >2 months
6. No prior intrapleural therapy
7. No chance in systemic therapy within 2 weeks
8. No significantirradiation to affected hemithorax
9. Unilateral non-chylous effusion

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Comments

 

activated - 12/94

closure date - 9/99

current accrual - 500 patients as of 9/30/99

accrual target increased due to a higher than expected percentage of deaths within 30 days and non-reexpansion

POSTER presented at ASCO, 2000

*open only to credentialled surgeons

Randomized trial of Open vs VATS for pulmonary metastases

Originating Group

CALGB 39804

P.I.: Dr. Joshua Sonett

Participating Groups

Objectives

1. To compare the overall survival between a minimally-invasive and open approach to the treatment of isolated pulmonary metastases.
2. To compare the failure-free survival between a minimally-invasive and open appraoch to the treatment of isolated pulmonary metastases
3. To compare patterns of recurrence with minimally invasive and open approaches to the treatment of isolated pulmonary metastases, and to determine what factors are predictive of recurrence
4. To describe and compare the complications and morbidity associated with minimally-invasive and open approaches to metastasectomy.
5. To test whether patients undergoing VATS will have a significantly better quality of life over a six month period than those undergoing an open resectin for the treatment of isolated pulmonary metastases, in terms of their physical symptoms,physical, vocational and social functioning,psychological state and body image.

Eligibility

1. Pulmonary metastases identified by spiral CT scan
2. Documented previous cancer with no history of previous metastasectomy.
3. The primary tumor must be definitively controlled. No evidence of primary tumor recurrence either locally or systemically with the patient having evidence of pulmonary metastasis only.
4. No extra-pulmonary metastatic disease or evidence of mediastinal lymph node involvement. Lymph nodes >1.0cm on CT scan must be proven to be benign by tissue biopsy (mediastinoscopy).
5. The pulmonary metastases must be judged all amenable to minimally-invasive resection by the credentialled thoracic surgeon. There may be multiple lesions (4 or less), unilateral or bilateral, as long as they can all be resected by VATS with curative intent (complete removal of all documented lesions).
6. <=4 lesions.
7. Performance status 0-2.
8. Age > 18 years.

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Randomized prospective trial of mediastinal lymph node sampling versus complete lymphadenectomy during the conduct of pulmonary resection in patients with N0 and N1 (less than hilar) no-small cell carcinoma

Originating Group

ACS-OG Z0030

P.I.: Dr. Mark Allen Dr. Gail Darling Dr. Robert Ginsberg

Endpoints

1. To compare mediastinal lymph node sampling to complete mediastinal lymph node dissection with reference to identification of occult mediastinal lymph node metastasis.
2. To assess whether complete mediastinallymph node dissection adversely effects the patient in reference to operative time, postoperative complications, duration of chest drainage and length of hospitalization, as compared to mediastinal lymph node sampling.
3. To evaluate whether complete mediastinal lymph node dissection improves local recurrence-free survival and local-regional recurrence-free survival as compared to mediastinallymph node sampling.

Pre-operative Eligibility

1. Patient must have biopsy proven or suspected, clinically resectable, T1 or T2, N0 or non-hilar N1, M0 non-small cell carcinoma of the lung.
2. Patients who have not had a tissue diagnosis established preoperatively must have this established intraoperatively prior to registration/randomization by TruCut biopsy or wedge resection and frozen section.
3. If pre-operative mediastinsoscopy has been performed, the patient must not have been found to have N2 disease at mediastinoscopy.
4. If pre-operative mediastinscopy has not been performed, all lymph nodes in the hilum and mediastinum must measure < 1cm. in the short axis diameter on pre-operative CT scan.
5. Patient must be medically fit for surgery. Patient must be a candidate for complete resection of the carcinoma via pneumonectomy, bilobectomy , lobectomy, or anatomic segmentectomy with or without sleeve resection. A patient in whom the surgeon plans to perform only a wedge resection for treatment is not eligible.
6. Patient must be 18 yrs of age or older.
7. Patient's performance status must be less than 3 on the ECOG/Zubrod scale.
8. Patient must not have received prior chemotherapy or radiotherapy for this cancer.
9. A cancer survivor is eligible provided that the following criteria are met: a) the patient has undergone potentially curative therapy for all prior malignancies, (b) there has been no evidence of any prior malignancies for at least 5 years, and (c) the patient has been deemed by their treating physician to be at low risk for recurrence from prior malignancies.

Intra-operative Eligibility Requirements

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Comments

Prospective randomized trial of postoperative adjuvant therapy in patients with completely resected Stage II and IIIa non-small cell lung cancer

Originating Group

ECOG #3590

P.I.: Dr. S. Keller

Participating Groups

Objectives

1. To determine if combination chemotherapy plus thoracic radiotherapy is superior to thoracic radiotherapy alone in prolonging survival in patients with completely resected Stage II and Stage IIIa non-small cell lung cancer.
2. To determine if combination chemotherapy plus thoracic radiotherapy is superior to thoracic radiotherapy alone in preventing local recurrence in patients with resected Stage II and Stage IIIa non-small cell lung cancer.

Eligibility

1. Histologic documentation of non-small cell lung cancer.
2. Stage II (T1-2, N1M0) or Stage IIIa (T1-2N2M0; T3N1-2M0) disease according to the ISSC. A pathologic diagnosis of Stage II/IIIa must have been made at the time of surgical resection to be included in the study. Cervical mediastinoscopy is required for any patient whose CT scan shows a mediastinal lymph node >1.5cm. in cross-sectional diameter. It the tumor is in the left upper lobeor left hilar region, level 5/6 lymph nodes with a cross-sectional diameter >1.5cm must be biopsied. A minimum of three stations must be sampled: one ipsilateral, 7, and one contralateral. If microscopic disease is present in one mediastinal nodal level, the patient is eligible for the study. If more than one level has tumor, or if extranodal disease is present in even one level, the patient is not eligible. Patients who are not required to undergo cervical mediastinoscopy and who are found to have extranodal disease at the time of surgical biopsy are eligible.
3. Surgery consisting of lobectomy, sleeve resection, bilobectomy or pneumonectomy, as determined by the attending surgeon based on intraoperative findings.
4. Surgery within 42 days prior to randomization.
5. Undergone complete resection of the tumor along with a complete intraoperative mediastinal node dissection or nodal sampling. All gross disease must have been removed at the time of surgery. All surgical margins of resection must be negative for tumor.
6. ECOG 0 or 1.
7. Ineligiblitiy criteria: a) prior chemotherapy (other than topical therapy), prior thoracic irradiation, or prior immunotherapy within 5 years of study entry, b) previous or concurrent malignancy other than curatively treated non-melanoma skin cancer or insitu cervical cancer unless a 5 year no-treatment disease-free interval intervenes, c) medical contraindication to chemotherapy, surgery, or irradiation, d)T3N0, small cell lung carcinoma (including "mixed" histology), bronchioalveolar carcinoma of lobar or multi-lobar involvement, or SVC syndrome.

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Comments

trial closed

Accrual Goal of 420 patients reached 3/97

***ABSTRACT presented at ASCO, 1999***

Pre-resection minimally invasive surgical restaging of Stage III (mediastinal node positive) non-small cell lung cancer (NSCLC)

Originating Group

CALGB 39803

Co P.I.'s: Dr. Malcolm DeCamp and Dr. Michael Jatklitsch

Participating Groups

Objectives

1. To evaluate the feasibility of using videothoracoscopy to access and identify residual viable cancer in mediastinal lymph nodes and/or to evaluate for other conditions which render patients unresectable (pleural carcinomatosis or T4 primary tumors) following prior mediastinoscopy and a period of neoadjuvant theapy for Stage IIIa (N2) NSCLC.
2. To evaluate the safety (morbidity and mortality) of pre-resectional thoracoscopic therapy for Stage IIIa (N2) NSCLC.
3. To assess the accuracy (falce-negative rate) for thoracoscopic mediastinal restaging after prior mediastinoscopy and induction therapy.

Eligibility

1. Histologic documentation of Stage IIIa NSCLC by mediastinoscopy performed prior to induction therapy. Previously treated relapsed patients are not eligible.
2. Prior treatment: >2 cycles of platinum-based combination chemotherapy with or without radiotherapy (>=40Gy) or radiotherapy alone (>=40Gy) must be completed within 42 days of registration.
3. No distant metastatic disease or local disease progression. Patients with stable or responding local disease are eligible. Those with local disease progression defined as a 25% increase in local tumor size or the appearance of new areas of malignant disease are ineligible.
4. No previous intrapleural surgery on the ipsilateral side.
5. ECOG performance status 0-2.

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Comments

Preoperative Chemotherapy + Surgery versus Surgery alone in patients with early stage NSCLC

Originating Group

Dr. Paul A. Bunn, University of Colorado 303-315-3007

Participating Groups

• MDACC : Dr. Bill Putnam
• ECOG : Dr. John Roberts
• NCCTG : Dr. Dan Miller
• RTOG : Dr. Robert Ginsberg
• CTSU : http://www.ctsu.org

   

  Objectives

• To assess, in an Intergroup randomized phase III setting, whether preoperative chemotherapy improves survival compare with surgery alone.

  Eligibility Criteria

• 1. Pathologically documented NSCLC, clinical stage IB (T2N0), II (T1-2,N1 and T3N0), or IIIA (T3N1) - clinical N1 status allowed only if mediastinoscopy is negative
• 2. Bidimensionally measurable disease or unidimensionally evaluable disease.
• 3. SWOG performance status 0-1.
• 4. No prior chemotherapy, radiation therapy, or surgery for NSCLC within 5 years

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Eligible Patient

        Randomize

        Surgery alone vs. Induction Paclitaxel + Carboplatin

        Follow up

Comments

• accrual goal 600 patients
• accrual is 87/600 as of Feb. 2001

Phase III double-blind randomized trial of 13-cis retinoic acid (13-CRA) to prevent second primary tumors (SPTs) in Stage I non-small cell lung cancer

Originating Group

MDACC ID91-025

P.I.: Dr. J. Roth

Participating Groups

Objectives

1. To evaluate the efficacy of 13-cis-retinoic acid (13-cRA) in reducing the incidence of SPTs in patients who have been treated for Stage I non-small cell lung cancer with complete surgical resection.
2. To evaluate the qualitative and quantitative toxicity of low-dose 13-cRA in a daily administration schedule.
3. To compare the overall survival of patients treated with 13-cRA vs. patients treated with placebo.

Eligibility

1. Patients who had histologic proof of complete resection of a non-small cell lung cancer (e.g. squamous, adenocarcinoma, large cell carcinoma, etc.) which was staged postoperatively as Stage I (T1N0M0, T2N0M0), who are currently free of disease.
2. Patients may not have received and may not currently be receiving chemotherapy, radiotherapy, or immunotherapy for lung cancer.
3. Eligible patients are those between 6 weeks and up to 36 months from date fo surgical resection.
4. Pathology material from the initial diagnosis must be available for review if recurrence occurs.
5. Age > 18 yrs, females not of childbearing potential and signed informed consent.
6. Bilirubin < 1.5mg%, SGPT < 56 IU/ml., or SGOT < 40 IU/ml. , WBC >3,000 cu/mm, platelet > 100,000 cu/mm, creatinine < 1.5 mg%, fasting triglycerides < 320 mg/dL.
7. Life expectancy > 12 months and Zubrod performance status 0-2.
8. Ineligiblity criteria: a) use of megadose vitamin A (> 25,000 IU/day), or > 30mg/day of beta-carotene within 3 months of study entry or during study, b) concurrent cancers or any prior cancer history within 5 years except localized non-melanoma skin cancer, c) history of greater than one lung cancer primary at anytime, d) synchronous lesions, even though resectable.

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Comments

trial completed

accrual goal of 1232 patients reached in 2/97

Phase II study of VIP (Etoposide, Ifosfamide and Cisplatin) in the treatment of invasive thymoma

Originating Group

ECOG E1C93

P.I.: Dr. P. Loehrer

Participating Groups

Objectives

1. To evaluate the objective response rate in extensive thymoma treated with VIP plus G-CSF.
2. To evaluate the duration of remission and survival in patients with extensive disease treated with VIP plus G-CSF.
3. To evaluate the toxicity of the VIP regimen in this population.

Eligibility

1. Histologically confirmed thymoma or thymic carcinoma.
2. Patients must have extensive disease (distant disease, pleural or pulmonary metastases with or without mediatinal disease, or, for patients withprior radiotherapy, distant metastasis or documented progressive disease in site of previous radiotherapy).
3. Patients with de novo limited disease as defined as disease confined to mediastinum and ipsilateral supraclavicular lymph nodes (such that all disease can be confined to a single radiotherapy portal) are not eligible if they are candidates for surgical resection or definitive radiation therapy.
4. Patientsmust have measurable disease with at least 1 bidimensional measurable lesion. Baseline measurements must be contained within 4 weeks prior to registration.
5. Patients must have adequate renal function (serum creatinine < 1.5 x the upper limit of normal, or calculated creatinine clearance >50 ml/min). Baseline measurements must be obtained within 2 weeks prior to registration.
6. Patients must have adequate hepatic function (serum bilirubin < 2.0 mg/dl). Baseline measurements must be obtained within 2 weeks prior to registration.
7. Patients must have adequate bone marrow function (WBC > 4,000/mm3), platelet count > 125,000/mm3). Baseline measurements must be obtained within 2 weeks priorto registration.
8. Patients who are receiving corticosteroids for myasthenia gravis are eligible for this protocol but they should remain on stable dose of corticosteroids after baseline measurements are obtained.
9. Patients must not have received prior systemic chemotherapy.
10. Patients must not have a history of uncontrolled congestive heart failure which would preclude adequate hydration.
11. Patients must have an ECOG performance status of 0, 1 or 2.
12. Patients must not have acute intercurrent complications such as infection or post surgical complications.
13. Patients must not have had a previous malignancy within the previous 5 years except previously treated basal cell carcinoma of the skin or in-situ carcinoma of breast or cervix.
14. Age > 18 years of age.
15. Patients must not be pregnant or lactating.
16. Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception.
17. Patients must have signed written informed consent.

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Comments

Publications

1. Abstract: Loehrer PJ, Jiroutek M, Aisner S, et al. Phase II trial of etoposide, ifosfamide and cisplatin in patients with advanced thymoma or thymic carcinoma: Preliminary results from an ECOG coordinated trial. Proceedings of ASCO, 1998;17:30a.

Phase II prospective randomized study of adjuvant chemoradiation in resected Stage I + II non small cell lung cancer with a companion tumor marker evaluation

Originating Group

NCIC CTGBR.10

P.I.: Dr. T. Winton

Participating Groups

Objectives

1. To determine whether adjuvant chemotherapy with cisplatinum and vinorelbine following standard treatmentwith surgery in stage I/II NSCLC improves locoregional control, or overall survival or decreases distant metastatic disease compared to observation.
2. To determine whether or not RAS mutations have prognostic significance.

Eligibility

1. Histological proof of completely resected T2N0 or T1-2N1 non-small cell lung cancer
2. A preoperative chest CT scan must be completed and intraoperative mediastinal lymph node resection or sampling should be attempted. Any mediastinal lymph node > 1.5 cm. must have been biopsied and histologically negative for the patient to be eligible for the trial.
3. Surgery may consist of lobectomy, sleeve resection, bilobectomy or pneumonectomy. Patients who have had segmentectomies or wedge resections are not eligible for this study.
4. ECOG Performance Status 0-1
5. Ineligibility Criteria: Patients who have have a diagnosis of breast cancer, melanoma or hypernephroma are ineligible. Patients with treated non-melanomaous skin cancer or carcinoma in situ of the cervix are eligible as are patients with cancers of any other type, if they remain free of recurrence and metastases five years or more following the end of treatment. Patients with bronchioalveolar carcinoma of lobar or multi-lobar involvement are ineligible whereas if it presented as a discrete solitary mass or nodule the patient is eligible. A patient with a) a combination of small cell and non-small cell carcinoma, or b) more than one discrete area of apparent primary cancer, or c) T3 tumor, or d) disease at nodal station #10 (considered N2 disease) is ineligible.

Comments

 

activated	8/94
accrual target	450 patients
accrual	435/450 randomized as of 10/2000

Phase II intergroup trial for superior sulcus lung cancer (Pancoast tumor) with concurrent chemoradiation as induction therapy

Originating Group

SWOG 9416

P.I.: Dr.V.Rusch

Participating Groups

Objectives

1. To assess the feasibility and toxicity of treating patients who have Pancoast tumors without mediastinal or supraclavicular nodal involvement (T3-4, N0-1) with cisplatin and VP-16 for two cycles, concurrent with a program of continuous, fractionated chest radiation followed by surgical resection and boost chemotherapy.
2. To assess the objective response rate, resectability rate, and proportion of patients free of microscopic residual disease after such an approach.

Eligibility

1. Histological or cytological evidence of Stage IIIa (T3N0-1) or Stage IIIb (T4N0-1) non-small cell lung cancer of the superior sulcus without rib or vertebral body involvement, or superior sulcus tumors with involvement of the chest wall (T3), or superior sulcus tumors with invasion of the vertebral bodies or involvement of the subclavian vessels (T4). Each may or may not be associated with the Pancoast syndrome. Patients with mediastinal or supraclavicular nodal involvement (N2-3) are not eligible for this study.
2. Patients with two or more parenchymal lesions in the same lung or in both lungs are ineligible.
3. Mediastinal exploration is required to establish eligibility.
4. Patients with pleural effusions are eligible if : when present before mediastinoscopy or exploratory thoracotomy they are transudative with negative cytology on two separate thoracenteses. If present only after pre-registration exploratory or staging thoracotomy but not before, effusions may either be transudate or exudate with negative cytology on a single thoracentesis.
5. Patients with either pericardial effusions or superior vena cava syndrome are ineligible.
6. No evidence of distant metastatic disease on CT of the abdomen and head or on bone scan.
7. No prior chemotherapy or radiotherapy for lung cancer. Prior thoracotomy is allowed only for diagnosis or staging purposes.
8. No prior malignancy is allowed except for adequately treated basal cell or swuamous cell skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.

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Comments

 

trial closed

11/98

accrual target

of 99 patients reached 8/99

Publication : Induction chemoradiation and surgical resection for non-small cell lung carcinomas of the superior sulcus: Initial Results of Southwest Oncology Group Trial 9416 (Intergroup 0160). Rusch VW, Giroux DJ, Kraut MJ, et al. JTCVS;121:472-483

Phase I study of isolated lung perfusion with paclitaxel and moderate hyperthermia in patients with unresectable pulmonary malignancies

 

Originating Group

Thoracic Oncology Section, Surgery Branch, NCI, Bethesda MD

P.I.: Dr. David S. Schrump

Participating Groups

None

Objectives

1. To establish maximum tolerated dose and Phase II dosage of paclitaxel administered via hyperthermic retrograde isolated lung perfusion (ILuP) in patients with unresectable pulmonary malignancies.
2. To define the nature of the toxic effects of paclitaxel administered by retrograde hyperthermic ILuP.
3. To evaluate the pharmacokinetic profile of paclitaxel in lung tissues and blood when this drug is administered by retrograde hyperthermic ILuP. The relationship between pharmacodynamic parameters and toxicities will be examined.

Eligibility

1. Unresectable primary lung cancer or pulmonary metastases. Patients with bilateral metastases may be considered for staged lung perfusions. Patients with unresectable bronchoalveolar carcinomas, or previously treated primary lung cancer may be considered for ILuP. Patients with prior thoracic surgery are for study.
2. Patients may have disease outside the confines of the thorax, provided the bulk of the disease in the chest is the greatest threat to their survival.
3. Life expectancy greater than three months.
4. Patients must be 18 years of age or older.
5. No chemotherapy, or bioligic therapy within 30 days prior to the lung perfusion.
6. No radiation therapy to the chest within six months and no history of nor current evidence of interstitial lung disease.
7. ECOG performance status of 0-1.
8. Patients must have adequate pulmonary reserve evidenced by pulmonary function tests to tolerate pneumonectomy, a resting oxygen saturation greater than 90%, a normal Aa (alveolar-arterial) gradient and a pCO2 less than 45 mmHg by arterial blood gas.
9. Platelet count greater than 100,000, Hgb greater than 10gm.dl, WBC greater than 3,500/ml, normal PT/PTT, and adequate hepatic function as evidenced by a total bilirubin, and AST and ALT less than 1.5 times ULN. Creatnine must be less than 1.6.
10. Patients must be willing to sign an informed consent indicating that they are aware of the neoplastic nature of their illness, the experimental nature of the therapy, alternative treatments, potential benefits, and risks.

Schema

Not Available

Comments

Activated 12/1999

Target Accrual 39 patients

Accrual 0/39 as of 12/1999

Phase I study of decitabine-mediated induction of tumor antigen and tumor suppressor gene expression in lung cancer patients

 

Originating Group

Thoracic Oncology Section, Surgery Branch, NCI, Bethesda, MD

P.I.: Dr. David S. Schrump

Participating Groups

None

Objectives

1. Evaluation of pharmacokinetics and toxicity of continuous 72 hour intravenous infusion of decitabine in lung cancer patients.
2. Analysis of NY-ESO-1 expression in lung cancer specimens before and after decitabine treatment.
3. Analysis of serologic response to NY-ESO-1 before and after decitabine treatment.
4. Analysis of p16 tumor suppressor gene expression before and after decitabine treatment.

Eligibility

1. Histologically or sytologically-proven primary small cell or non-small cell lung cancer with no evidence of intracranial or leptomeningeal metastases.
2. No chemotherapy, biologic therapy, or radiation therapy within 30 days prior to decitabine treatment.
3. ECOG performance status 0-2.
4. FEV 1.0 and DLCO greater than 40% predicted; pCO2 greater than 45mmHg, and pO2 greater than 60mmHg on room air
5. Platelet count greater than 100,000, Hgb greater than 10gm/dl, WBC greater than 3,500/ul, normal PT/PTT and adequate hepatic function as evidence by a total bilirubin of less than 1.5x the upper limit of normal. Serum creatinine less than or equal to 1.6mg/ml or the creatinine clearance must be greater than 60ml/min.
6. The patient must be winning to sign an informed consent, and undergo tumor biopsies to evaluate NY-ESO-1 and p16 expression prior to, and after decitabine treatment.

Schema

Not Available

Comments

Activated 10/1999

Target Accrual 20 patients

Accrual 1/20 as of 12/1999

Concurrent chemotherapy plus radiotherapy versus concurrent chemotherapy plus radiotherapy followed by surgical resection for Stage IIIa (N2) non-small cell lung cancer

Originating Group

RTOG 9309

P.I.: Dr. V. Rusch

Participating Groups

CALGB 9592 ; Dr. M. Krasna ECOG R9309: Dr. R. Feins NCIC CTGBR.13 Dr. G. Darling SWOG 9336 Dr. T. Rice NCCTG R9309 Dr. C. Deschamps NCI Navy 93-17: Dr. H. Hosannah (301) 295-2552

Objectives

1. To assess whether concurrentchemotherapy and radiotherapy followedby surgical resection results in a significant improvement in progression-free, median, and long-term (2-year, 5-year) survival compared to the same chemotherapy plus standard radiotherpay alone for patients with stage IIIa (N2 positive) non-small cell lung cancer.
2. To evaluate the patterns of local and distant failure for patients enrolled in each arm of the study, in order to assess the impact of the therapy on local control and distant metastases.

Eligibility

1. Single, newly diagnosed primary non-small cell lung cancer stage IIIa (T1, T2 or T3) with ipsilateral positive mediastinal lymph nodes (biopsy-proven) and negative contralateral mediastinal and supraclavicular lymph nodes by biopsy or CT criteria
2. If a pleural effusion is present either before or after prestudy mediastinoscopy or exploratory thoracotomy, a thoracentesis with negative cytology must be performed, OR when pleural fluid is present only on the CT scan and not the chest xray, but is deemed too small to tap safely under either Ct or ultrasound guidance, the patient is eligible and this must be clearly documented.
3. Karnofsky performance status >= 70
4. Weight loss within 3 months of diagnosis is <=10%
5. No evidence of distant metastatic disease based upon CT or MRI of brain, bone scan, CT of the chest and upper abdomen
6. Ineligibility criteria: Two or more parenchymal lung lesions, previous diagnosis of lung cancer, previous surgical resection of the current primary lesion,small cell carcinoma and lobar or diffuse bronchoalveolar cell carcinoma, prior radiotherapy or chemotherapy for lung cancer, pericardial effusion, superior vena cava syndrome, current chemotherapy, prior or current malignancy other than adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or either ductal or lobular carcinoma of the breast or other malignancy except lung cancer is allowed if a 5 year disease-free interval has elapsed since last treatment.

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Comments

 

activated	3/94
accrual target	612 patients
accrual	394/612 as of 10/2000

Canadian Lung Volume Reduction Study

Comments

1. target accrual 350 patients
2. accrual 45/350 as of 10/2000

A prospective randomized trial of Bleomycin vs Doxycycline vs Talc for intrapleural treatment of malignant pleural effusion

Originating Group

 

ECOG #8592 P.I.: Dr. N. Snow

Participating Groups

 

NCCTG #C8592 Dr.C.Deschamps

Objectives

1. To compare intrapleural bleomycin, doxycycline, and talc in the treatment of malignant pleural effusions with respect to: a) time to recurrence of the effusion, b) necessity forfurther treatment of recurrent effusions, c) extent of post-instillation complications, including pain severity and dyspnea, d) duration of chest tube or soft catheter drainage required following pleurodesis, e) duration of hospitalization for retreatment of MPE at time of recurrence, and f) survival.

Eligibility

1. Cytologically confirmed malignant pleural effusion or an exudative effusion with a positive pleural biopsy from any tumor type.
2. Drainage of the affected pleural space by tube thoracostomy (chest tube > 24F) or soft catheter with: a) re-expansion of the lung demonstrated by CXR, b)continuing drainage less than 250/24hrs, or equivalent measured over at least 4 hours if chest tube employed.
3. ECOG performance status 0,1, or 2.
4. No prior intrapleural therapy or change in systemic therapy for the previous 2 weeks priorto on study (patients may be started on systemic chemo- or hormonotherapy following pleurodesis)
5. No significant prior irradiation to the affected hemithorax (painful bone lesions may be irradiated on the affected side but the field must not include a significant portion of the pleura.
6. No prior systemic bleomycin.
7. No bilateral effusions requiring treatment, chylous effusion, thoracoscopic lysis of adhesions on the side being treated, or prior instillation of sclerosing agents on the side being treated.

Schema

Comments

 

activated	11/96
accrual target	480 patients
closed 11/98 due to slow accrual, may reopen after the talc slurry/talc poudrage trial closed

A prospective randomized phase III trial comparing trimodality therapy (cis-platin, 5-FU, radiotherapy, and surgery) to surgery alone for esophageal cancer

Originating Group

CALGB 9781

P.I.: Dr. Mark Krasna

Participating Groups

NCCTG C9781 Dr. Daniel Miller

ECOG C9781 Dr. Richard Feins

RTOG 97-16 Dr. Robert J. Ginsberg

Objectives

1. To compare overall 5 year survival rates between the two treatment arms.
2. To compare treatment failure at five years between the two treatment arms.
3. To assess and compare the toxicities of each approach.
4. To compare the incidence and pattern of local(gastric or esophageal bed or regional lymph nodes) and distant(supraclavicular lymph nodde, liver, peritoneal carcinomatosis,or lung, brain, etc.) recurrence.
5. To evaluate the prognostic ability of noninvasive and minimally invasive pretreatment staging with regard to survival and recurrence.
6. To evaluate the ability of pre-resection adjuvant chemotherapy with concomitant radiation therapy to render tumors to lower stages. This comparison will be made between pre-study and pre-operative CT scans.
7. to evaluate the impact of positive lymph nodes on survival and recurrence.

Eligibility

1. Histologically documented squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (below 20cm) or gastroesophageal junction.
2. No distant metastases. Any lesions suspicious as metastases on CT should be followed with testing by ultrasound, MRI, or biopsy to prove eligibility.
3. Tumor must be considered surgically resectable (T1-3,NX).
4. Patients with the following are eligible: regional thoracic lymph node (N1) metastases, lymph node metastases level 15-20 < or equal to 1.5cm by CT, supraclavicular nodes < or equal to 1.5cm by CT that are not palpable on clinical exam.
5. Patients with the following are ineligible: radiographically positive lymph nodes levels 15-20 which are >1.5cm, or palpable supraclavicular nodes or supraclavicular nodes which are radiographically positive, i.e. >1.cm.

Schema

Comments

A prospective multi-institutional study in resectable lung cancer of the prognostic significance and incidence of occult distant disease

Originating Group

ACS-OG Z0040

P.I.: Dr. Robbin Cohen 322-442-5849

Objectives

Primary objective: To model the relationships between each of these indicators of occult micrometastases and overall survival. Secondary objectives:

1. To study the relationships between the indicators and conventional histology.
2. To model overall survival considering the indicators and other patient attributes which are of prognositc significance.
3. To study the relationships between the indicators and the site of first recurrence.
4. To estimate the prevalence of the indicators.
5. To model the relationships between the indicators and disease-free survival.

Eligibility

1. Patient must have clinically resectable, non-small cell carcinoma of the lung and be clinical stage I, IIa, IIb, or IIIa.
2. If preoperative mediastinoscopy has been performed, a patient with N1 and N2 disease is eligible. A patient with N3 disease is not eligible.
3. Patient must be anticipated to have a thoracotomy with the intention of a curative resection for primary NSCLC. The preoperative assessment of resectability should, at a minimum, include a CT scan of the chest and upper abdomen, through the adrenal glands.
4. Patients must be medically fit for surgery and be a candidate for complete resection of the carcinoma via pneumonectomy, bilobectomy, lobectomy, or anatomic segmentectomy, with or without sleeve resection.
5. Patient must not have evidence of pleural effusion by physical assessment, lateral cxr, or by chest ct scan.
6. Patient must not have had ipsilateral thoracotomy, or thoracoscopy within the past 5 years.
7. Patient's performance status must be less than 3 on the ECOG/Zubrod scale
8. Patient must not have received prior chemotherapy or radiotherapy for this cancer.
9. Patient must be 18 yrs or older and must sign a study-specific consent form prior to study entry.
10. A cancer survivor is eligible providing the following criteria are met: (a) the patient has undergone potentially curative therapy for all prior malignancies, and (b) there has been no evidence of any prior malignancies for the at least 5 years.

Schema

Comments

A Phase III trial of surgical resection and chemotherapy (carboplatin and taxol) with or without adjuvant radiotherapy for mediastinoscopy negative but thoracotomy positive N2 Stage IIIa non-small cell lung cancer

Originating Group

CALGB 9734

P.I.: Dr. Leslie J. Kohman

Participating Groups

NCCTG

P.I.: Elizabeth Johnson, M.D. (904) 953-8200 (p), (904) 953-7211 (f)

Objectives

1. To compare overall survival of surgically resected patients with Stage II or IIIa NSCLC who are treated by postoperative chemotherapy (carboplatin and taxol) with or without adjuvant radiotherapy.
2. To assess the differential impact of a sequential treatment regimen (chemotherapy followed by radiotherapy) vs. a chemotherapy only regimen on overal health related quality of life and depressive symptoms.
3. To compare failure-free survival of surgically resected patients who are treated by postoperative chemotherapy with or without adjuvant radiotherapy.
4. To describe patterns of local and distant recurrence.
5. To detetmine the toxicities associated with chemotherapy with or without adjuvant radiotherapy
6. To assess the impact of social support as a predictor variable for survival and a mediating variable for overall treatment satisfaction.
7. To provide a clinical data basse for the further study of molecular markers and prognostic factors in lung cancer.

Eligibility

1. Histologically documented NSCLC which has been completely resected according to surgical guidelines, Stage II or IIIa (T1-3N1, T1-3N2)
2. Informed consent
3. CALGB performance status 0-1
4. Pulmonary function sufficient to withstand chemotherapy and radiation therapy

Schema

Comments

A Phase III Study of Adjuvant Chemotherapy after resection of Stage I (T2N0M0) Non-small cell lung cancer

Originating Group

CALGB 9633

P.I.: Dr. Michael Maddaus

Participating Groups

Objectives

1. To determine if adjuvant chemotherapy can favorably alter the prognosis of the subgroup of resected stage I patients who, following complete surgical resection of their disease, are defined as "high risk" based on the presence of a T2N0 tumor (according to the criteria of the International Staging System for lung cancer).
2. To compare failure-free survival of patients with T2N0 Stage I NSCLC who have and have not been treated with adjuvant chemotherapy.
3. To determine the toxicities associated with adjuvant chemotherapy.
4. To describe the pattern of disease recurrence.

Eligibility

1. Histologically documented NSCLC
2. Complete surgical resection (lobectomy or pneumonectomy) Stage I ( T2N0M0)
3. Randomization must occur within 4-8 weeks of resection
4. No prior chemotherapy or radiotherapy
5. Age >= 18 years
6. Performance status 0-1
7. No concomitant malignancy

Schema

Comments

 

activated	10/96
accrual target	500 patients
current accrual	199/500 patients as of 10/2000