NCT03051464RecruitingPhase 2/3
Randomizing Two Radiotherapy Boost Options to Avoid Rectal Cancer Surgery
A Phase III Study Testing Two Dose Escalation Strategies to Increase the Population of Complete Responders After Radiation Therapy in the Context of Organ Preservation for Patients With Rectal Cancer
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 131 (estimated)
- First submitted
- 7 Feb 2017
- Start date
- 25 Apr 2017
- Primary completion date
- Jan 2028
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT03051464
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 131
- From 25 Apr 2017 to the primary completion date, Jan 2028
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with previous pelvic radiation
Other illness
- Extension of malignant disease to the anal canal
Other
- Evidence of distant metastasis
- Tumors staged as T4
- Tumors larger than 5 cm in length
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Le Centre Hospitalier de l'Université de Montreal Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Centre hospitalier universitaire de Québec Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.