Tests a shorter radiation course to save the rectum in rectal cancer
Tests shortened pelvic radiation, with or without chemotherapy, in adults with rectal cancer.
Key facts
- Who runs it
- Neil Kopek
- Where
- Montreal, CanadaSee the site
- Trial code
- Registry title
- Organ Preservation in Rectal AdenoCa Using Hypofractionated Pelvic RT(Hypo-OPRA)
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 35 people, planned
- Started
- 16 Aug 2023
- Expected to end
- 30 Jun 2029
- Type of study
- Interventional
- Treatments tested
- Radiation Therapy
- FOLFOX regimen
- Capecitabine
- Record updated
- 28 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 adenocarcinoma that has grown through the rectal wall area (mesorectum) but has not spread to other organs, and who can have surgery.
- Age
- 18 to 90 years
- Sex
- All sexes
- Disease stage
- Invasive adenocarcinoma of the rectum confirmed under the microscope. On pelvic MRI, the mesorectum is involved or breached, including nearby organs (T3-T4). No proven metastatic disease on CT of chest and abdomen.
- Earlier treatment
- No previous chemotherapy. No previous radiotherapy to the pelvis, including brachytherapy.
Main reasons for not taking part
- Previous chemotherapy or pelvic radiotherapy
- Metastatic disease, including metastases that could be removed
- T1 or T2 N0 disease without extra-mural venous invasion
- Another cancer within the last 5 years (except treated basal cell skin cancer or cervical carcinoma in situ)
- Pregnant, breastfeeding, or pre-menopausal women not using adequate contraception
The registry criteria, word for word
Show all 25 criteriaShow less
Who can take part
- Histologically confirmed invasive adenocarcinoma of the rectum
- Pelvic MRI defined disease (at least one of the following):; mesorectum involved or breached - includes involvement of adjacent organ(s) (T3-T4)
- 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 chemotherapy
- 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)
- T1 or T2 N0 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
- 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 CentreMontreal, CanadaContact: Neil Kopek, M.D.Taking people
About the trial
What the trial wants to find out
The combination of preoperative pelvic RT - either long-course chemoradiotherapy (LCCRT) or short-course radiotherapy (SCRT)- followed by surgery has been the standard of care in the curative treatment of locally advanced adenocarcinoma of the rectum for decades. Some patients however achieve a complete clinical response (cCR) to their preoperative treatment which opens the possibility of avoiding surgery and consequently preserving the rectum. There now exists a growing body of data from centres around the world validating the safety of a surveillance approach in clinical complete responders treated with LCCRT.
The group in the trial
- Hypofractionated Pelvic RadiotherapyTreatment being tested
A single arm consisting of hypofractionated RT dose of 25 Gy in 5 fractions once daily fractions of intensity modulated radiotherapy (IMRT) with a simultaneous integrated boost up to 35 Gy on sites of gross disease (tumour and lymphadenopathy).
Treatment: Radiation Therapy, FOLFOX regimen, and Capecitabine
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
- Organ Preservation in Rectal Adenocarcinoma Using Hypofractionated Pelvic Radiotherapy (Hypo-OPRA): A Phase II Clinical Trial
- Plain-language title
- Tests a shorter radiation course to save the rectum in 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 NCT06991465, who can take part
- Record updated
- 28 May 2025