← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

SUPPRESS Trial 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.Check my eligibility

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.See study design

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.

SUPPRESS Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My cancer has spread to 1-5 spots outside the brain, affecting up to 3 organs, and is under 5cm.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

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.

SUPPRESS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression free survival

Secondary outcome measures

Grade ≥ 3 toxicity Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Local control

Overall survival

+2 more

SUPPRESS 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

~200

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

366 Previous Clinical Trials

129,591 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

Frequently Asked Questions

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

Does the experimental arm of this study have authorization from the FDA?

"Because this is a Phase 2 trial, and thus lacks evidence of efficacy, we have assigned Experimental arm an assessment score of 2 with regards to its safety."

Answered by AI

Are there any availabilities left for prospective participants in this clinical trial?

"A glance at clinicaltrials.gov reveals that this trial is actively seeking participants: the initial posting occurred on October 1st 2021, and it has seen its most recent update take place on November 11th 2022."

Answered by AI

What is the sample size for this clinical investigation?

"Affirmative. Information gleaned from clinicaltrials.gov confirms that this experiment, which was initially published on October 1st 2021, is actively searching for participants. The trial seeks to enroll 46 individuals at one medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer

2021. "Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04989725.