Final results of phase III trial in regionally advanced unresectable non-small cell lung cancer - Radiation Therapy Oncology Group, Eastern Cooperative Oncology Group, and Southwest Oncology Group

Study objectives: The purpose of this phase III clinical trial was to test whether chemotherapy followed by radiation therapy resulted in superior sur vival to either hyperfractionated radiation or standard radiation in surgic ally unresectable non-small cell lung cancer. Design: Patients were prospectively randomized to 2 months of cisplatin, vi nblastine chemotherapy followed by 60 Gy of radiation at 2.0 Gy per fractio n or 1.2 Gy per fraction radiation delivered twice daily to a total dose of 69.6 Gy, or 2.0 Gy per fraction of radiation once daily to 60 Gy Patients were enrolled from January 1989 through January 1992, and followed for a po tential minimum period of 5 years, Setting: This trial was an intergroup National Cancer Institute-funded tria l within the Radiation Therapy Oncology Group, the Eastern Cooperative Onco logy Group, and the Southwest Oncology Group, Patients: Patients with surgically unresectable non-small cell lung cancer, clinical stage II, IIIA, and IIIB, were required to have a Karnofsky Perfo rmance Status of greater than or equal to 70 and a weight loss of < 5% for 3 months before study entry, Four hundred ninety patients were registered o n trial, of which 458 patients were eligible. Conclusion: Overall survival was statistically superior for the patients re ceiving chemotherapy and radiation vs the other two alms of the study. The twice-daily radiation therapy arm, although better, was not statistically s uperior in survival for those patients receiving standard radiation. Median survival for standard radiation was 11.4 months; for chemotherapy and irra diation, 13.2 months; and for hyperfractionated irradiation, 12 months. The respective 5-year survivals were 5% for standard radiation therapy, 8% for chemotherapy followed by radiation therapy, and 6% for hyperfractionated i rradiation.