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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 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

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

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

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor

446 Previous Clinical Trials

159,678 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies in this clinical experiment for participants?

"According to information on clinicaltrials.gov, participants are presently being recruited for this medical trial which was initially published on March 1st 2015 and revised most recently on September 8th 2022."

Answered by AI

Do I meet the prerequisites to be a part of this experiment?

"As part of this trial, 48 participants aged 18 to 90 years old with colorectal carcinoma must satisfy the essential criteria: involvement or breach of mesorectum (T3-T4), presence of extra-mural vascular invasion, tumor deposits in the mesorectum and an ECOG performance status score 0 or 1."

Answered by AI

How many participants are contributing to this clinical experiment?

"Affirmative, the information on clinicaltrials.gov states that this research project is presently engaging potential participants. The trial was initially listed on March 1st 2015 and underwent its most recent revision on September 8th 2022. This experiment seeks 48 individuals from 2 different locations for participation."

Answered by AI