Preserving the rectum in patients with rectal cancer using targeted radiation therapy
Organ Preservation in Rectal Adenocarcinoma Using Hypofractionated Pelvic Radiotherapy (Hypo-OPRA): A Phase II Clinical Trial
PHASE2 · McGill University Health Centre/Research Institute of the McGill University Health Centre · NCT06991465
This study is testing if targeted radiation therapy can help patients with rectal cancer avoid surgery while still keeping their cancer under control.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06991465 on ClinicalTrials.gov |
What this trial studies
This study investigates the potential for organ preservation in patients with locally advanced rectal adenocarcinoma who achieve a complete clinical response to short-course radiotherapy (SCRT). It aims to explore the safety and efficacy of a non-operative surveillance strategy, allowing patients to avoid surgery and its associated risks. The study will involve patients who are medically fit for oncologic resection and have specific disease characteristics as defined by pelvic MRI. By focusing on SCRT, the research seeks to validate findings from previous studies that suggest enduring clinical responses can be achieved without surgical intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and over with histologically confirmed invasive adenocarcinoma of the rectum and specific disease characteristics.
Not a fit: Patients with previous chemotherapy or radiotherapy to the pelvis, or those with uncontrolled cardiorespiratory comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for surgery in rectal cancer patients, minimizing surgical risks and improving quality of life.
How similar studies have performed: While most existing data on surveillance strategies in complete responders is based on long-course chemoradiotherapy, there is emerging evidence supporting the effectiveness of short-course radiotherapy, making this approach both novel and promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Previous chemotherapy * Previous radiotherapy to the pelvis (including brachytherapy) * 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 * Known dihydropyrimidine dehydrogenase deficiency * 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) * Taking warfarin or phenytoin or sorivudine * Gastrointestinal disorder which would interfere with oral therapy and its bioavailability * Pregnant, lactating, or pre-menopausal women not using adequate contraception * Unfit to receive any study treatment or subsequent surgical resection
Where this trial is running
Montreal, Quebec
- McGill University Health Centre — Montreal, Quebec, Canada (RECRUITING)
Study contacts
- Principal investigator: Neil Kopek, M.D. — Radiation Oncologist - Radiation Oncology
- Study coordinator: Neil Kopek, M.D.
- Email: neil.kopek@muhc.mcgill.ca
- Phone: 514-934-4400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colorectal Carcinoma