1020 / 1068
UNICANCER ACCORD 16 phase II trial
Primary endpoint: CR+PR 6 weeks after Tx; 15% increase, 81 pts required
Number
10 pts, + 6 pts after amendments (IMRT
mandatory, 5-FU reduced to 600 mg/m
2
/d1-3
Compliance
5/16 (31%) received the entire planned tx
Acute grade 3/4 tox
14 (88%), mainly general, digestive, skin
Deutsch E., et al. Ann Oncol 2013
Update: Levy A, et al. Radiother Oncol 2015
Late grade 3/4 tox
3 pts (%), perineal necrosis, fistula, pain, ...
Response 6 weeks
after Tx
11 assessable: CR 6, PR 5
Long-term outcome
(med. F/U: 4.6 years)
PFS (4 years): 53%, incl. 6 Local Failures