Comparing Two Radiation Boost Methods for Rectal Cancer Without Surgery
Tests two radiation boost methods after chemoradiation in adults with early rectal cancer.
Key facts
- Who runs it
- Sir Mortimer B. Davis - Jewish General Hospital
- Where
- Montreal and Québec, CanadaSee the 3 sitesAlso in 1 other country, 1 site
- Trial code
- Registry title
- Randomizing Two Radiotherapy Boost Options to Avoid Rectal Cancer Surgery
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 131 people, planned
- Started
- 25 Apr 2017
- Expected to end
- Jan 2030
- Type of study
- Interventional, 2 groups
- Treatments tested
- Complete responders and Non-complete responders
- Chemoradiation + EBRT Boost
- Chemoradiation + HDRBT Boost
- Record updated
- 30 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with rectal cancer that is small and has not spread to distant organs. It compares two radiation boosts to try to avoid rectal surgery.
- Age
- Older than 18 years, up to 80 years.
- Sex
- All sexes can join.
- Disease stage
- Rectal cancer staged T2-T3a,b N0-1 by MRI or ultrasound, with no distant spread. The tumour is less than 5 cm (2 in), covers less than half of the bowel wall, and is less than 10 cm (3.9 in) from the anal verge.
- Earlier treatment
- No previous radiation to the pelvis.
Main reasons for not taking part
- Previous pelvic radiation
- Distant metastases
- Cancer reaching the anal canal
- T4 tumours
- Tumours larger than 5 cm (2 in) in length
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patients with previous pelvic radiation
- Extension of malignant disease to the anal canal
- Evidence of distant metastasis
- Tumors staged as T4
- Tumors larger than 5 cm in length
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in Canada
Also in 1 other country, 1 site
- Jewish General HospitalMontreal, CanadaContact: Susanne KnoepfelTaking people
- Le Centre Hospitalier de l'Université de MontrealMontreal, CanadaContact: Nassima TalebTaking people
- Centre hospitalier universitaire de QuébecQuébec, CanadaContact: André-Guy Martin, MDTaking people
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- Chemoradiation + EBRT BoostTreatment being tested
standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5; Complete responders and Non-complete responders
Treatment: Complete responders and Non-complete responders and Chemoradiation + EBRT Boost
- Chemoradiation + HDRBT BoostTreatment being tested
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; Complete responders and Non-complete responders
Treatment: Complete responders and Non-complete responders and Chemoradiation + HDRBT Boost
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Comparing Two Radiation Boost Methods for Rectal Cancer Without SurgeryGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT03051464, who can take part
- Record updated
- 30 June 2026