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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