RecruitingPhase 3NCT06641791

Palliative Steroeotactic Body Radiotherapy vs Palliative Standard Radiotherapy in Patients With Advanced Head and Neck Cancer

A Phase III Randomized Controlled Trial Comparing Palliative Stereotactic Body Radiotherapy vs. Palliative Standard Radiotherapy in Patients With Advanced Head and Neck Cancer


Sponsor

Canadian Cancer Trials Group

Enrollment

196 participants

Start Date

Apr 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is being done to answer the following question: Does stereotactic body radiation therapy (SBRT) provide better cancer control compared to standard radiation therapy (RT) for those with advanced head and neck cancer?


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two types of radiation for people with advanced head and neck cancer who are not suitable for curative treatment: stereotactic body radiotherapy (SBRT, a precise high-dose approach given in fewer sessions) vs. standard palliative radiation. **You may be eligible if...** - You are 18 years or older - You have confirmed squamous cell carcinoma of the head and neck (mouth, throat, larynx, or related areas) - Your doctor has determined that curative radiation is not an option for you - Your overall health allows you to receive radiation (ECOG 0-3) - You have had recent imaging of the head/neck and chest **You may NOT be eligible if...** - You have nasopharyngeal carcinoma - You have had prior chemotherapy or immunotherapy - You have had prior radiation to the head and neck - Your tumor is in certain high-risk locations (e.g., very large tumors, near the brain or optic nerves) - You have scleroderma or CREST syndrome - You have visible spread to distant organs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStandard Radiotherapy (SRT)

2400 cGy in 3 fractions - day 0/7/21, OR, 2500 cGy in 5 fractions over 1 week

RADIATIONStereotactic Body Radiotherapy (SBRT)

4500 cGy in 5 fractions (twice a week to primary and nodal GTV, OR, 4000 cGy in 5 fractions twice a week if organs at risk.


Locations(6)

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Odette Cancer Centre

Toronto, Ontario, Canada

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06641791