NCT06991465RecruitingPhase 2
Organ Preservation in Rectal AdenoCa Using Hypofractionated Pelvic RT(Hypo-OPRA)
Organ Preservation in Rectal Adenocarcinoma Using Hypofractionated Pelvic Radiotherapy (Hypo-OPRA): A Phase II Clinical Trial
Source: ClinicalTrials.gov · Last updated 28 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 12 May 2025
- Start date
- 16 Aug 2023
- Primary completion date
- Sept 2027
- Lead sponsor
- Neil Kopek
- Diseases
- Colorectal cancer
- NCT number
- NCT06991465
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 35
- From 16 Aug 2023 to the primary completion date, Sept 2027
- 1 site in 1 country
- 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
- Previous chemotherapy
- Previous radiotherapy to the pelvis (including brachytherapy)
- Unfit to receive any study treatment or subsequent surgical resection
Other illness
- 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
Other
- Known dihydropyrimidine dehydrogenase deficiency
- Taking warfarin or phenytoin or sorivudine
- Pregnant, lactating, or pre-menopausal women not using adequate contraception
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.