Actively Recruiting
Organ Preservation in Rectal AdenoCa Using Hypofractionated Pelvic RT(Hypo-OPRA)
Led by Neil Kopek · Updated on 2025-05-28
35
Participants Needed
1
Research Sites
306 weeks
Total Duration
On this page
Sponsors
N
Neil Kopek
Lead Sponsor
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Organ Preservation in Rectal AdenoCa Using Hypofractionated Pelvic RT(Hypo-OPRA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed invasive adenocarcinoma of the rectum
- Pelvic MRI showing disease involving or breaching the mesorectum (T3-T4)
- Medically fit for oncologic resection
- ECOG performance status 0 or 1
- No evidence of metastatic disease on chest and abdomen CT scans
- Absolute neutrophil count greater than 1.5 x 10^9/L
- Platelet count greater than 100 x 10^9/L
- Serum transaminase less than 3 times the upper limit of normal
- Adequate renal function with Cockroft Gault estimation over 50 mL/min
- Bilirubin less than 1.5 times the upper limit of normal
- Ability to take oral medication
- Willing and able to give informed consent and comply with treatment and follow-up
- Age 18 years or older
You will not qualify if you...
- Previous chemotherapy
- Previous pelvic radiotherapy including brachytherapy
- Uncontrolled heart or lung conditions, including recent heart attack or unstable angina
- T1 or T2 N0 disease without extra-mural venous invasion
- Clear evidence of metastatic disease, including resectable metastases
- Severe bowel dysfunction without a defunctioning stoma or ileostomy
- Known deficiency in dihydropyrimidine dehydrogenase
- History of other cancer within 5 years except treated basal cell skin cancer or cervical carcinoma in situ
- Known Gilbert's disease (high bilirubin)
- Taking warfarin, phenytoin, or sorivudine
- Gastrointestinal problems that interfere with oral therapy
- Pregnant, breastfeeding, or pre-menopausal women not using effective contraception
- Not fit to receive study treatment or surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
Research Team
N
Neil Kopek, M.D.
CONTACT
T
Tarel Hijal, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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