Final results of phase III trial in regionally advanced unresectable XXXX : Radiation Therapy Oncology Group, Eastern Cooperative Oncology Group, and Southwest Oncology Group.

@entity1 @entity7841 @entity1149 @entity900 @entity5713
STUDY OBJECTIVES: The purpose of this phase III clinical trial was to test whether chemotherapy followed by radiation therapy resulted in superior survival to either hyperfractionated radiation or standard radiation in surgically unresectable @entity1149 . DESIGN: @entity1 were prospectively randomized to 2 months of @entity900 , @entity5713 chemotherapy followed by 60 Gy of radiation at 2.0 Gy per fraction 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. @entity1 were enrolled from January 1989 through January 1992, and followed for a potential minimum period of 5 years. SETTING: This trial was an intergroup National Cancer Institute-funded trial within the Radiation Therapy Oncology Group, the Eastern Cooperative Oncology Group, and the Southwest Oncology Group. @entity1 : @entity1 with surgically unresectable @entity1149 , clinical stage II, IIIA, and IIIB, were required to have a Karnofsky Performance Status of > or = 70 and a weight loss of < 5% for 3 months before study entry. Four hundred ninety @entity1 were registered on trial, of which 458 @entity1 were eligible. CONCLUSION: Overall survival was statistically superior for the @entity1 receiving chemotherapy and radiation vs the other two arms of the study. The twice-daily radiation therapy arm, although better, was not statistically superior in survival for those @entity1 receiving standard radiation. Median survival for standard radiation was 11.4 months; for chemotherapy and @entity7841 , 13.2 months; and for hyperfractionated @entity7841 , 12 months. The respective 5-year survivals were 5% for standard radiation therapy, 8% for chemotherapy followed by radiation therapy, and 6% for hyperfractionated @entity7841 .
