Radiation with chemotherapy and close monitoring for rectal cancer
Tests radiation plus chemotherapy, then monitoring, in adults with rectal cancer.
Key facts
- Who runs it
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Where
- Montreal, CanadaSee the 2 sites
- Trial code
- Registry title
- Patients With Rectal Cancer: a "Wait-and-see" Approach
- Status
- Recruiting
- People taking part
- 48 people, planned
- Started
- Mar 2015
- Planned end
- Jan 2026
- Type of study
- Interventional
- Treatments tested
- Radical external beam radiotherapy
- Record updated
- 15 May 2025
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 seen on pelvic MRI, fit for cancer surgery, with no spread to other organs. They get radiotherapy with chemotherapy and are then closely watched; surgery is offered if the cancer does not fully go away or comes back.
- Age
- 18 to 90 years
- Sex
- All sexes can join.
- Disease stage
- Rectal adenocarcinoma shown by biopsy. Pelvic MRI shows at least one of: tumour through the muscle layer (T2) or into the fat or nearby organs (T3-T4), invasion of blood vessels outside the bowel wall, tumour deposit in the mesorectum, or one or more involved mesorectal lymph nodes. No spread to other organs on CT of chest and abdomen.
- Earlier treatment
- No previous radiotherapy to the pelvis, including brachytherapy. People must be fit enough for cancer surgery.
Main reasons for not taking part
- Enlarged lymph nodes outside the mesorectum
- Proven spread of the cancer to other organs, including spread that can be removed
- Uncontrolled heart or lung disease, or a heart attack within 6 months
- Another cancer in the last 5 years (a few skin or cervix cancers aside)
- Taking warfarin, phenytoin or sorivudine, or known DPD deficiency
The registry criteria, word for word
Show all 24 criteriaShow less
Who can take part
- Pelvic MRI defined disease (at least one of the following):; mesorectum involved or breached - includes involvement of adjacent organ (s) (T3-T4); involvement of muscularis propria (T2); extra-mural vascular invasion; tumour deposit within the mesorectum; one or more involved mesorectal lymph node
- Patients are considered medically fit for oncologic resection
- ECOG performance status 0 or 1
- No evidence of established metastatic disease (CT chest and abdomen)
- Absolute neutrophil count >1.5x109/L; platelets >100x109/L,
- Serum transaminase <3 x ULN
- Adequate renal function (Cockroft Gault estimation >50 mL/min)
- Bilirubin <1.5 x ULN
- Ability to comply with oral medication
- Willingness and ability to give informed consent and comply with treatment and follow up schedule
- Age 18 or over
Who cannot take part
- Previous radiotherapy to the pelvis (including brachytherapy)
- Unfit to receive any study treatment or subsequent surgical resection
- Uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction within 6 months of randomisation)
- T1N0 disease without extra-mural venous invasion
- Unequivocal evidence of metastatic disease (includes resectable metastases)
- Major impairment of bowel function without defunctioning stoma/ileostomy (baseline grade 3 diarrhoea or clinically significant faecal incontinence)
- History of another malignancy within the last 5 years except successfully treated basal cell cancer of skin or carcinoma in situ of uterine cervix
- Known Gilberts disease (hyperbilirubinaemia)
- Gastrointestinal disorder which would interfere with oral therapy and its bioavailability
- Enlarged extramesorectal nodes
- Known dihydropyrimidine dehydrogenase deficiency
- Taking warfarin or phenytoin or sorivudine
- Pregnant, lactating, or pre-menopausal women not using adequate contraception
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 90 years old?
Where in Canada
- McGill University Health Center-Cedars Cancer CentreMontreal, CanadaContact: Marianna Perna, CCRP,CCRCTaking people
- McGill University Health Centre-Cedars Cancer CentreMontreal, CanadaContact: Neil Kopek, M.D.Taking people
About the trial
What the trial wants to find out
Patients with histologically proven adenocarcinoma of the rectum will receive pelvic radiotherapy to a dose of 45Gy in 25 fractions with a tumor boost to a dose of 9Gy in 5 fractions (thus total of 54Gy/30Fx to the primary tumor), combined with radio sensitizing chemotherapy. Patients will then be closely monitored, through endoscopy and imaging, for response to treatment and relapse. Salvage oncologic surgery to be offered if there is failure to achieve complete clinical response or in the event of a loco regional relapse.
The group in the trial
- Radical External Beam RT for Colorectal CaTreatment being tested
A single arm consisting of: Radical external beam RT dose of 54 Gy in 30fx with radiosensitizing chemotherapy as per institutional standard
Treatment: Radical external beam radiotherapy
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
- Radical External Beam Chemoradiation in Patients With Rectal Cancer: a "Wait-and-see" Approach
- Plain-language title
- Radiation with chemotherapy and close monitoring for rectal cancerGenerated 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 NCT03001362, who can take part
- Record updated
- 15 May 2025