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Radiation

Stereotactic Ablative Radiotherapy for Head and Neck Cancer (SUPPRESS Trial)

Phase 2
Recruiting
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Oligoprogression to 1-5 extracranial lesions ≤ 5cm and involving ≤ 3 organs. Progression at the primary tumor site should be counted within the total of 5 lesions. For patients with lymph node metastases, each node is counted as one site of metastasis
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Must not have
Presence of spinal cord compression
Metastatic disease that invades the GI tract (including esophagus, stomach, small or large bowel)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether it is better to give standard care or stereotactic ablative radiotherapy to people with metastatic head and neck cancer who have 1-5 new extracranial tumors.

Who is the study for?
Adults over 18 with metastatic head and neck cancer who've seen their disease progress on current systemic treatments. They must have a decent performance status, meaning they can carry out daily activities with varying degrees of assistance. The trial is for those with limited progression in up to 5 lesions that are less than 5cm and spread across no more than 3 organs.
What is being tested?
This phase II trial tests if using Stereotactic Ablative Radiotherapy (SABR) on up to five small progressing cancer spots while continuing current systemic therapy is better compared to just switching therapies or supportive care as decided by the doctor.
What are the potential side effects?
Potential side effects from SABR may include skin reactions, fatigue, mild pain or discomfort at the treatment site, possible damage to nearby organs depending on where the radiation is targeted, and general inflammation.

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 1-5 spots outside the brain, affecting up to 3 organs, and is under 5cm.
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I can take care of myself and am up and about more than half of my waking hours.
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My cancer has grown by more than 20% or I have new cancer spots since my last treatment.
Select...
My cancer is confirmed in the head or neck area.
Select...
I am 18 years old or older.
Select...
My head or neck cancer has spread, confirmed by tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have spinal cord compression.
Select...
My cancer has spread to my digestive system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression free survival
Secondary study objectives
Grade ≥ 3 toxicity Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Local control
Overall survival
+2 more

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental SABR armExperimental Treatment1 Intervention
Definitive SABR to oligoprogressive lesions + continue current systemic therapy
Group II: Standard of careActive Control1 Intervention
Switch to subsequent systemic therapy line, best supportive care or continue current systemic line
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Experimental arm
2016
N/A
~220

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
377 Previous Clinical Trials
131,474 Total Patients Enrolled

Media Library

Experimental arm (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT04989725 — Phase 2
Head and Neck Cancers Research Study Groups: Standard of care, Experimental SABR arm
Head and Neck Cancers Clinical Trial 2023: Experimental arm Highlights & Side Effects. Trial Name: NCT04989725 — Phase 2
Experimental arm (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04989725 — Phase 2
~11 spots leftby Dec 2025
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