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.

Schema

Comments

trial closed

Accrual Goal of 420 patients reached 3/97

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