Lower GI 2016

UNICANCER ACCORD 16 phase II trial Primary endpoint: CR+PR 6 weeks after Tx; 15% increase, 81 pts required

10 pts, + 6 pts after amendments (IMRT mandatory, 5-FU reduced to 600 mg/m 2 /d1-3

Number

Compliance

5/16 (31%) received the entire planned tx

Acute grade 3/4 tox

14 (88%), mainly general, digestive, skin

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

Deutsch E., et al. Ann Oncol 2013 Update: Levy A, et al. Radiother Oncol 2015