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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

Must not have

Patient who have received any previous therapy (radiation , chemotherapy) for rectal cancer

Patient with tumor involving the anal canal

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years post treatment

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had treatment for rectal cancer before.

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My cancer is located in the anal canal.

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My tumor cannot be surgically removed due to its attachment to nearby structures.

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I spend most of my time in bed or sitting due to my health.

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I have cancer in both my colon and rectum, not just rectal cancer.

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My rectal tumor is not adenocarcinoma but another type like sarcoma or lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The feasibility of the new device

Toxicity using the new device

Workload

Secondary study objectives

Local control

Tumor response

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: 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.

0 / 12Eligibility criteria met