Randomizing Two Radiotherapy Boost Options to Avoid Rectal Cancer Surgery

NCT03051464 · tracked via the Priya Life Science Canada tracker

Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Phase

Phase 2/3

Started

2017-04-25

Last updated

2026-06-30

Condition(s) studied

Stage II Rectal CancerOrgan PreservationNon-operative TreatmentRectal Cancer (Stage III)Rectal Cancer Patients

Investigational drug(s) / intervention(s)

Complete responders and Non-complete respondersChemoradiation + EBRT BoostChemoradiation + HDRBT Boost

Complete responders and Non-complete responders: Patients that are complete responders will not have surgery. Patients that are non-complete responders will have surgery.

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

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

Study summary

A randomized study of 131 patients. Patients with a clinical T2-3 N0-1 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions).

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Rectal cancer patients, clinically staged as T2-T3a,b N0-1 by MRI or endoscopic/trans-rectal ultrasound * Rectal cancer staged as N0-1 by MRI or EUS/TRUS * No metastatic lesion * Rectal tumor occupying less than half of the circumference * Tumor less than 5 cm on its largest dimension * Tumor located at less than 10 cm from the anal verge * Tumor penetration less than 5 mm in the mesorectal fat * Tumor accessible for brachytherapy * Lumen accessible for colonoscopy * Patient should be a suitable candidate for brachytherapy and chemotherapy * Older than 18 years of age * Adequate birth control measures in women of childbearing potential * Written informed consent Exclusion Criteria: * Patients with previous pelvic radiation * Evidence of distant metastasis * Extension of malignant disease to the anal canal * Tumors staged as T4 * Tumors larger than 5 cm in length

Primary outcome measure(s)

TME-free survival — 2 years post treatment
Time from date of randomization to either TME or death in the intention to treat population

Trial sites (4)

Facility	City	Region	Status
UT Southwestern Medical Center	Dallas	Texas	Recruiting
Le Centre Hospitalier de l'Université de Montreal	Montreal	Quebec	Recruiting
Jewish General Hospital	Montreal	Quebec	Recruiting
Centre hospitalier universitaire de Québec	Québec	Quebec	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03051464 on ClinicalTrials.gov ↗ ← All trials in Canada