101
Participants
Start Date
April 1, 2019
Primary Completion Date
February 15, 2021
Study Completion Date
September 30, 2023
Avelumab
"Eligible patients will receive:~CHEMORADIOTHERAPY PLUS AVELUMAB:~* CAPECITABINE 825 mg/sqm/bid p.o. 5 days/week~* EXTERNAL-BEAM IRRADIATION 50.4 GY in 28 fractions over 5.5 weeks~* AVELUMAB 10 mg/Kg ev over 1 hour every 2 weeks at days 1, 14, 28, 42, 56, 70~Surgery with TME must be performed at week 8-10 after the end of CTRT. The final choice of surgical procedure (ie, abdominoperineal surgery or anterior resection) is at the surgeon's discretion."
Capecitabine
"Eligible patients will receive:~CHEMORADIOTHERAPY PLUS AVELUMAB:~* CAPECITABINE 825 mg/sqm/bid p.o. 5 days/week~* EXTERNAL-BEAM IRRADIATION 50.4 GY in 28 fractions over 5.5 weeks~* AVELUMAB 10 mg/Kg ev over 1 hour every 2 weeks at days 1, 14, 28, 42, 56, 70~Surgery with TME must be performed at week 8-10 after the end of CTRT. The final choice of surgical procedure (ie, abdominoperineal surgery or anterior resection) is at the surgeon's discretion."
EXTERNAL---BEAM IRRADIATION 50.4 GY
Surgery with TME must be performed at week 8-10 after the end of CTRT. The final choice of surgical procedure (ie, abdominoperineal surgery or anterior resection) is at the surgeon's discretion.
Policlinico Gemelli, Rome
Gruppo Oncologico del Nord-Ovest
OTHER