Split-course radiotherapy of XXXX stages C and D1. A Radiation Therapy Oncology Group Study.

@entity1 @entity5 @entity294 @entity150 @entity204
One hundred forty-eight @entity1 with advanced @entity150 Stages C or D1 were randomized between continuous-course radiotherapy (6,000 cGy in 30 fractions of 200 cGy each, over 6 weeks) and split-course radiotherapy (2,750 cGy in 10 fractions of 275 cGy each, over 2 weeks; a rest period of 3 weeks; 2,750 cGy in 2 weeks); 139 are analyzed in this report. Ninety-four percent of the @entity1 have been followed at least 5 years or until @entity204 . The @entity1 ranged in age from 45 to 80 with a median of 69. Seventy-six percent of the @entity1 were males and 58% had Stage C disease. In @entity1 with information on the size of the @entity5 , in 66% the lesion measured 5 cm or larger; 26% had a diameter of 8 cm or larger. In general, the treatment groups were well balanced with respect to @entity1 characteristics. Both treatment groups tolerated therapy well. Eighty-seven percent of the @entity1 completed therapy, 66% as planned. Fifty-four percent experienced at least one severe reaction, with the most common types being @entity294 (28%), frequency of urination (24%), soreness or burning on urination (25%), and urgency of urination (19%). Late effects of therapy were minimal. Median survival times were 11.5 months and 9.4 months for continuous-course and split-course, respectively. The treatment differences were not significant (p = 0.88; Mantel-Haenszel stratified by stage and sex). Forty percent of the @entity1 became free of all clinically detectable disease following radiotherapy either alone or in combination with additional surgery (40% for continuous-course, 4% cleared by surgery, and 39% for split-course, 3% cleared by surgery). When the @entity5 measured less than 5 cm, the clearance rate was 61% (20/33) vs. 33% (13/39) for 5-7.9 cm, and 24% (6/25) for 8 cm or larger (p less than 0.01; chi2 test for linear trend). For those who became disease free, median time disease free within the irradiated volume was 72 months for continuous-course and is currently undefined for split-course; median time disease free was 28 months and undefined, respectively. There were no significant treatment differences in @entity5 control for any of these endpoints. The ultimate long-term @entity5 control in the pelvis was 28% (19/68) for continuous- and 25% (18/71) for split-course therapy.(ABSTRACT TRUNCATED AT 400 WORDS)
