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Radiation Therapy
Radiotherapy for Rectal Cancer
N/A
Recruiting
Led By Neil Kopek, M.D.
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Tumour deposit within the mesorectum
ECOG performance status 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Study Summary
This trial is testing a new way to give radiation and chemotherapy for rectal cancer. The goal is to see if it will kill the cancer cells and help prevent the cancer from coming back.
Who is the study for?
This trial is for adults over 18 with rectal cancer that hasn't spread to other parts of the body. They should be fit enough for surgery, have certain MRI findings like muscle or lymph node involvement, and good organ function. People can't join if they've had pelvic radiation before, have severe bowel issues without a stoma, serious heart/lung problems, another recent cancer (except skin or cervical), specific genetic conditions affecting drug metabolism, are on certain medications, or are pregnant without contraception.Check my eligibility
What is being tested?
The study tests high-dose radiotherapy combined with chemotherapy in rectal cancer patients. The goal is to see if this treatment can allow some patients to avoid surgery by closely monitoring them afterwards and only operating if the cancer doesn't respond completely or comes back locally.See study design
What are the potential side effects?
Possible side effects include skin irritation at the radiation site, fatigue from both treatments, nausea and diarrhea due to chemotherapy. There's also a risk of low blood counts leading to infection or bleeding complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread to the fatty tissue near my rectum.
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I am fully active or can carry out light work.
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My cancer has spread to the muscle layer of my organ.
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My MRI shows my cancer has spread to or beyond the mesorectum.
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My cancer has spread to the blood vessels outside the organ.
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My kidneys are working well.
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I have cancer in one or more lymph nodes near my rectum.
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I am 18 years old or older.
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My scans show no signs of cancer spread beyond the original site.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of a "wait and see" approach
Trial Design
1Treatment groups
Experimental Treatment
Group I: Radical External Beam RT for Colorectal CaExperimental Treatment1 Intervention
A single arm consisting of: Radical external beam RT dose of 54 Gy in 30fx with radiosensitizing chemotherapy as per institutional standard
Find a Location
Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
450 Previous Clinical Trials
161,798 Total Patients Enrolled
Neil Kopek, M.D.Principal InvestigatorRadiation Oncologist
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to the fatty tissue near my rectum.I am not fit for the study treatment or surgery.I have been diagnosed with Gilbert's syndrome.I am medically cleared for cancer surgery.I am fully active or can carry out light work.My cancer is early stage and hasn't spread to my veins.My heart or lung condition is not well-controlled.I am not pregnant, breastfeeding, or if pre-menopausal, I am using effective birth control.I have had radiation treatment to my pelvic area before.My cancer has spread to other parts of my body.My cancer has spread to the muscle layer of my organ.I am currently taking warfarin, phenytoin, or sorivudine.My MRI shows my cancer has spread to or beyond the mesorectum.I have a known deficiency in the enzyme dihydropyrimidine dehydrogenase.My cancer has spread to the blood vessels outside the organ.My kidneys are working well.I have severe bowel issues without a stoma.I have enlarged lymph nodes outside the rectal area.I do not have a stomach or bowel problem that affects medication absorption.I have not had any cancer in the past 5 years, except for skin or cervical cancer that was successfully treated.I have cancer in one or more lymph nodes near my rectum.I am 18 years old or older.My scans show no signs of cancer spread beyond the original site.
Research Study Groups:
This trial has the following groups:- Group 1: Radical External Beam RT for Colorectal Ca
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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