No Surgery Trial / Two Dose-escalation Strategies

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

131

Participants

Timeline

Start Date

April 25, 2017

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2030

Conditions
Stage II Rectal Cancer
Interventions
PROCEDURE

Complete responders and Non-complete responders

Patients that are complete responders will not have surgery. Patients that are non-complete responders will have surgery.

RADIATION

Chemoradiation + EBRT Boost

45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5

RADIATION

Chemoradiation + HDRBT Boost

45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions

Trial Locations (4)

J4M2A5

TERMINATED

Hôpital Pierre Boucher, Longueuil

H2X0A9

NOT_YET_RECRUITING

Le Centre Hospitalier de l'Université de Montreal, Montreal

H3T 1E2

RECRUITING

Jewish General Hospital, Montreal

G2L2Z3

RECRUITING

Centre hospitalier universitaire de Québec, Québec

All Listed Sponsors
lead

Sir Mortimer B. Davis - Jewish General Hospital

OTHER