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4

Mid eighties first phase III trials

Arm A

Arm B

US (RTOG 8704) XRT+ 5 FU XRT + 5 FU-Mito C

EORTC 22861 XRT

XRT + 5 FU-Mito C

UKCCCR ACT I XRT

XRT + 5 FU-Mito C

US (RTOG-8704)

XRT+ 5 FU XRT + 5 FU-MMC p value

Complete response

86%

92,2%

Colostomy- free survival

59%

71%

0,014

Colostomy rate

22%

9%

0,002

DFS

51%

73%

OS

71%

78,1%

0,31