Status:
RECRUITING
Organ Preservation in Rectal AdenoCa Using Hypofractionated Pelvic RT(Hypo-OPRA)
Lead Sponsor:
Neil Kopek
Collaborating Sponsors:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Colorectal Carcinoma
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
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 treatmen...
Detailed Description
At McGill, SCRT is used routinely as a pre-operative radiotherapy schedule for locally advanced adenocarcinomas of the rectum. Likewise SCRT followed by chemotherapy is already used routinely at McGil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06991465
Start Date
August 16 2023
End Date
June 30 2029
Last Update
May 28 2025
Active Locations (1)
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1
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1