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Brachytherapy
Combined Radiotherapy for Rectal Cancer (Whistle Trial)
N/A
Recruiting
Led By Te Vuong, MD
Research Sponsored by Sir Mortimer B. Davis - Jewish General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is not suitable for surgery nor chemotherapy due to medical conditions
Tumor of 5 cm or less length, non obstructive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years post treatment
Awards & highlights
Whistle Trial Summary
This trial will test a new, approved endorectal brachytherapy applicator which may improve patient quality of life and treatment time.
Who is the study for?
This trial is for adults over 18 with invasive rectal adenocarcinoma, diagnosed without removing most of the tumor. The cancer must be palpable or visible via proctoscope, within 15 cm from the anal verge, and clinically staged as T2-T3 N1+. Patients should be unfit for surgery/chemotherapy due to medical conditions and geographically available for follow-up.Check my eligibility
What is being tested?
The study tests a new endorectal brachytherapy applicator approved by Health Canada against traditional external beam radiotherapy combined with older brachytherapy methods. It aims to improve quality of life and treatment efficiency in rectal cancer management.See study design
What are the potential side effects?
Potential side effects may include discomfort at the application site, radiation-related skin changes, fatigue, bowel disturbances like diarrhea or constipation, and possible risks associated with exposure to radiation.
Whistle Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I cannot undergo surgery or chemotherapy due to my health conditions.
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My tumor is 5 cm or smaller and not blocking anything.
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My rectal cancer was confirmed by a biopsy without removing most of the tumor.
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I have been diagnosed with rectal cancer through a biopsy.
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My rectal cancer is at a specific stage, confirmed by MRI or ultrasound.
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My tumor can be felt by a doctor's exam or seen with a scope and is within 15 cm of the anal opening.
Whistle Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The feasibility of the new device
Toxicity using the new device
Workload
Secondary outcome measures
Local control
Tumor response
Whistle Trial Design
1Treatment groups
Experimental Treatment
Group I: External beam radiotherapy + Endorectal brachytherapyExperimental Treatment1 Intervention
In this study, all participants will receive a treatment of external beam radiotherapy without chemotherapy, which will be followed by three (3) treatments of endorectal brachytherapy with the new applicator.
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Who is running the clinical trial?
Sir Mortimer B. Davis - Jewish General HospitalLead Sponsor
55 Previous Clinical Trials
21,115 Total Patients Enrolled
Icad, Inc.Industry Sponsor
4 Previous Clinical Trials
1,303 Total Patients Enrolled
Te Vuong, MDPrincipal InvestigatorSir Mortimer B. Davis - Jewish General Hospital
6 Previous Clinical Trials
392 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot undergo surgery or chemotherapy due to my health conditions.My cancer is located in the anal canal.I am older than 18 years.I have had treatment for rectal cancer before.My tumor is 5 cm or smaller and not blocking anything.My tumor cannot be surgically removed due to its attachment to nearby structures.I spend most of my time in bed or sitting due to my health.My rectal cancer was confirmed by a biopsy without removing most of the tumor.I have been diagnosed with rectal cancer through a biopsy.My rectal cancer is at a specific stage, confirmed by MRI or ultrasound.I can be treated with surgery or qualify for the Morpheus study.I have cancer in both my colon and rectum, not just rectal cancer.My tumor can be felt by a doctor's exam or seen with a scope and is within 15 cm of the anal opening.My rectal tumor is not adenocarcinoma but another type like sarcoma or lymphoma.
Research Study Groups:
This trial has the following groups:- Group 1: External beam radiotherapy + Endorectal brachytherapy
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the size of the sample population for this research project?
"Affirmative. Documents on clinicaltrials.gov demonstrate that this experiment, which was initially published on February 1st 2023, is currently enlisting participants. Approximately 45 subjects must be sourced from a single medical site."
Answered by AI
Has recruitment for this experiment commenced yet?
"The clinical trial, initially posted on February 1st 2023, is still in progress and seeking participants. The most recent edit was made on October 25th 2022 according to the details found on clinicaltrials.gov."
Answered by AI
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