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

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