Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if combination chemotherapy is more effective with or without radiation therapy for stage IIIA non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without radiation therapy in treating patients who have stage IIIA non-small cell lung cancer that has been surgically removed.

OBJECTIVES: I. Compare the overall survival of surgically resected patients with limited stage IIIA non-small cell lung cancer who are treated by postoperative chemotherapy with or without adjuvant radiotherapy. II. Compare failure free survival of these patients. III. Describe the patterns of local and distant recurrence in these patients. IV. Determine the toxicities associated with chemotherapy with or without adjuvant radiotherapy in these patients.

OUTLINE: This is a randomized, multicenter study. Four to eight weeks after surgery, all patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on days 1, 22, 43, and 64. Following completion of four courses of chemotherapy, patients are randomized into one of two treatment arms. Arm I: Patients receive no further therapy. Arm II: Patients receive radiotherapy 5 days a week for 5 weeks to the mediastinum, beginning 2.5 to 4 weeks after completion of chemotherapy. Patients are followed at least every 4 months for 2 years, then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 480 patients will be accrued for this study over 2 years.

• Drug: carboplatin
• Drug: paclitaxel
• Radiation: radiation therapy

• Perry MC, Kohman L, Bonner J, et al.: Updated analysis of a phase III study of surgical resection and chemotherapy (paclitaxel/carboplatin) (CT) with or without adjuvant radiation therapy (RT) for resected stage III non-small cell lung cancer (NSCLC) CALGB 9734. [Abstract] J Clin Oncol 23 (Suppl 16): A-7145, 656s, 2005.
• Perry MC, Kohman LJ, Bonner JA, et al.: A phase III study of surgical resection and chemotherapy (paclitaxel/carboplatin) (CT) with or without adjuvant radiation therapy (RT) for resected stage III non-small cell lung cancer (NSCLC): CALGB 9734. [Abstract] Lung Cancer 41 (Suppl 2): A-O-183, S55, 2003.

DISEASE CHARACTERISTICS: Histologically confirmed stage IIIA non-small cell lung cancer that has been completely resected by lobectomy, bilobectomy, pneumonectomy, or sleeve lobectomy through any incision (thoracoscopic or video assisted resection is acceptable) No known residual disease present Involvement in N2 nodes must have been determined only at the time of surgical exploration or by postoperative pathologic diagnosis All grossly involved nodes must be removed at surgery No positive mediastinoscopy (if lymph nodes on CT scan are greater than 1.5 cm in diameter, mediastinoscopy is required)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ZUBROD 0-1 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT no greater than upper limit of normal Renal: Creatinine clearance at least 20 mL/min Other: Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent growth factors Chemotherapy: No prior chemotherapy for non-small cell lung cancer No other concurrent chemotherapy Endocrine therapy: No concurrent hormone therapy except: Steroids for adrenal failure Hormones for nondisease related conditions Dexamethasone as an antiemetic Radiation therapy: No prior radiotherapy for non-small cell lung cancer Surgery: See Disease Characteristics

• National Cancer Institute (NCI)
• North Central Cancer Treatment Group
• Southwest Oncology Group