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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
Must not have
Unfit to receive any study treatment or subsequent surgical resection
Known Gilberts disease (hyperbilirubinaemia)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
No Placebo-Only Group

Summary

This trial involves treating patients with rectal cancer using a combination of radiation and chemotherapy. The radiation aims to kill cancer cells, and the chemotherapy makes these cells more sensitive to the radiation. This approach targets patients whose cancer may not respond well to surgery alone.

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not fit for the study treatment or surgery.
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I have been diagnosed with Gilbert's syndrome.
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My cancer is early stage and hasn't spread to my veins.
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I am not pregnant, breastfeeding, or if pre-menopausal, I am using effective birth control.
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I have had radiation treatment to my pelvic area before.
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My cancer has spread to other parts of my body.
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I am currently taking warfarin, phenytoin, or sorivudine.
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I have a known deficiency in the enzyme dihydropyrimidine dehydrogenase.
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I have severe bowel issues without a stoma.
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I have enlarged lymph nodes outside the rectal area.
Select...
I do not have a stomach or bowel problem that affects medication absorption.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of a "wait and see" approach

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
470 Previous Clinical Trials
166,913 Total Patients Enrolled
Neil Kopek, M.D.Principal InvestigatorRadiation Oncologist

Media Library

Radical external beam radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03001362 — N/A
Colorectal Cancer Research Study Groups: Radical External Beam RT for Colorectal Ca
Colorectal Cancer Clinical Trial 2023: Radical external beam radiotherapy Highlights & Side Effects. Trial Name: NCT03001362 — N/A
Radical external beam radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03001362 — N/A
~5 spots leftby Oct 2025
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