A Study on the Timing of FOLFOX for Patients With Operable, Node Positive Rectal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

November 30, 2009

Primary Completion Date

December 31, 2022

Study Completion Date

December 31, 2022

Conditions
Operable T2-3N+M0 Rectal Cancer (Stage III)
Interventions
DRUG

FOLFOX

"* Oxaliplatin\* 85 mg/m2 IV in 500 mL of D5W over 120 minutes~* Folinic Acid (Leucovorin)\* 400 mg/m2 IV in 250 ml D5W over 120 minutes~* 5-Fluorouracil (5-FU) 400 mg/m2 IV bolus, after Folinic Acid~* 5-Fluorouracil\*\* 2400 mg/m2 IV over 46 h in D5W to a total volume of 92 mL by continuous infusion at 2 mL/hour.~* Repeat every 14 days for 6 cycles in the arm A and to be completed with 6 cycles after surgery and 12 cycles in arm B.~If necessary the schedule may be modified +/- 3 days."

RADIATION

high dose rate endorectal brachytherapy

High dose rate endorectal brachytherapy, consisting in a total dose of 26 Gy in 4 daily fractions of 6.5 Gy.

Trial Locations (8)

J8T 8R2

Hôpital de Gatineau, Gatineau

J4V 2H1

Hôpital Charles LeMoyne, Greenfield Park

J4M 2A5

Centre Hospitalier Pierre-Boucher, Longueuil

H2X 3J4

CHUM-Hôpital St-Luc, Montreal

H3T 1E2

Sir Mortimer B. Davis - Jewish General Hospital, Montreal

J2S 4Y8

Hôpital Honoré-Mercier, Saint-Hyacinthe

J6T 6C1

Hôpital du Suroît, Salaberry-de-Valleyfield

G1R 2J6

CHUQ - Hôtel-Dieu de Québec, Québec

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Sir Mortimer B. Davis - Jewish General Hospital

OTHER