Actively Recruiting
Patients With Rectal Cancer: a "Wait-and-see" Approach
Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2025-05-15
48
Participants Needed
2
Research Sites
565 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients with histologically proven adenocarcinoma of the rectum will receive pelvic radiotherapy to a dose of 45Gy in 25 fractions with a tumor boost to a dose of 9Gy in 5 fractions (thus total of 54Gy/30Fx to the primary tumor), combined with radio sensitizing chemotherapy. Patients will then be closely monitored, through endoscopy and imaging, for response to treatment and relapse. Salvage oncologic surgery to be offered if there is failure to achieve complete clinical response or in the event of a loco regional relapse.
CONDITIONS
Official Title
Patients With Rectal Cancer: a "Wait-and-see" Approach
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pelvic MRI showing at least one of: mesorectum involved or breached including adjacent organ involvement (T3-T4), involvement of muscularis propria (T2), extra-mural vascular invasion, tumor deposit in mesorectum, or one or more involved mesorectal lymph nodes
- Medically fit for oncologic resection
- ECOG performance status of 0 or 1
- No signs of metastatic disease on CT chest and abdomen
- Absolute neutrophil count above 1.5 x 10^9/L and platelets above 100 x 10^9/L
- Serum transaminases less than 3 times the upper limit of normal
- Adequate kidney function with Cockroft Gault estimate above 50 mL/min
- Bilirubin less than 1.5 times the upper limit of normal
- Able to take oral medication as required
- Willing and able to give informed consent and follow treatment and follow-up schedules
- Age 18 years or older
You will not qualify if you...
- Previous radiotherapy to the pelvis, including brachytherapy
- Enlarged extramesorectal lymph nodes
- Uncontrolled heart or lung disease, including recent myocardial infarction or poorly controlled angina within 6 months
- T1N0 disease without extra-mural venous invasion
- Clear evidence of metastatic disease, including resectable metastases
- Major bowel function problems without a defunctioning stoma or ileostomy, such as severe diarrhea or significant fecal incontinence
- History of other cancers within 5 years except treated basal cell skin cancer or cervical carcinoma in situ
- Known dihydropyrimidine dehydrogenase deficiency
- Known Gilbert's disease with hyperbilirubinemia
- Taking warfarin, phenytoin, or sorivudine
- Gastrointestinal disorders that interfere with oral medication absorption
- Pregnant, breastfeeding, or pre-menopausal women not using adequate contraception
- Unfit to receive study treatments or surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
McGill University Health Center-Cedars Cancer Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
2
McGill University Health Centre- Cedars Cancer Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
Research Team
N
Neil Kopek, M.D.
CONTACT
M
Marianna Perna, CCRP,CCRC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here