Randomized study of postoperative radiotherapy and simultaneous @entity2903 without adjuvant chemotherapy for XXXX .

@entity1 @entity5 @entity2904 @entity2903 @entity463
PURPOSE: To evaluate the efficacy of simultaneous postoperative @entity2903 radiochemotherapy in @entity463 @entity1 . @entity1 AND METHODS: From February 2002 to July 2004, n = 65 @entity1 from 11 German centers with macroscopic complete @entity5 resection were randomized to receive either postoperative radiotherapy alone (RT, n = 35) or postoperative radiotherapy with simultaneous @entity2903 (RT + @entity2904 , n = 30). @entity1 were stratified according to age (< or =/>50 years) and WHO performance score (0-1 vs. 2). RT consisted of 60 Gy in 30 fractions. In the RT + @entity2904 arm, oral @entity2904 was administered daily at a dose of 75 mg/m(2) including weekends (40-42 doses). Adjuvant treatment was not given, but in both arms, @entity1 with recurrent @entity5 and in good condition (WHO 0-2) were scheduled for salvage chemotherapy with @entity2904 . RESULTS: The trial was stopped early due to the results of EORTC-study 26981-22981 that showed a survival benefit for the combination of concomitant and adjuvant @entity2904 compared to radiotherapy alone. In total, 62/65 @entity1 were evaluable. Stratification variables were well balanced (< or = 50 years 26% vs. 20%, WHO 0-1 91% vs. 100%). Neither overall survival (median 17 vs. 15 months) nor progression-free survival (median 7 vs. 6 months) differed significantly between the two arms. In the RT (RT + @entity2904 ) arm, 76% (62%) of the progressing @entity1 received salvage chemotherapy with @entity2904 , 36% (50%) had a second resection. There was a time-constant trend for increased general quality of life (EORTC questionnaire QLQ C30) and brain-specific quality of life (EORTC questionnaire B20) in the combined arm. Lymphopenia G3-4 was more frequent (33 vs. 6%) in the RT + @entity2904 arm. CONCLUSION: After early closure of this trial, a benefit for progression-free survival for simultaneous @entity2904 radiochemotherapy alone could not be demonstrated. In both arms, salvage therapies were frequently used and probably had a major effect on overall survival.
