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

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