Induction Chemotherapy for Locally Advanced Rectal Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

June 1, 2021

Primary Completion Date

June 1, 2025

Study Completion Date

June 1, 2026

Conditions
Rectal Cancer
Interventions
DRUG

FOLFOXIRI Protocol

"FOLFOXIRI consists of oxaliplatin, irinotecan, leucovorin and 5-fluorouracil and is administered every 2 weeks:~Dosing:~* Day 1: irinotecan 165 mg/m2 body-surface area (BSA) intravenously (IV), followed by oxaliplatin 85mg/m2 BSA IV in combination with leucovorin 400mg/m2 BSA, followed by:~* Day 1-2: 3200 mg/m2 BSA of continuous 5-fluorouracil IV~* Day 3-14: rest days.~Both regimen are initially administered for four cycles. In case of responsive or stable disease, a 5th and 6th cycle of FOLFOXIRI will be administered.~In case of unacceptable toxicity, the aforementioned dosages can be reduced or one or more chemotherapeutical agents can be omitted at discretion of the medical oncologist and will be noted in the patient's medical file. At discretion of the medical oncologist, a start dosage of 75% of the advised dosage could be considered in patients above 70 years of age."

Trial Locations (7)

Unknown

Catharina Hospital Eindhoven, Eindhoven

Netherlands Cancer Institute, Amsterdam

Maastricht University Medical Centre, Maastricht

Radboud University Medical Centre, Nijmegen

Erasmus MC Cancer institute, Rotterdam

University Medical Centre, Utrecht

Isala hospital, Zwolle

All Listed Sponsors
lead

Catharina Ziekenhuis Eindhoven

OTHER