RecruitingPhase 2NCT04989725

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

Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer: A Phase II Randomized Trial

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrollment

46 participants

Start Date

Oct 1, 2021

Study Type

INTERVENTIONAL

Conditions

Head and Neck Cancer Metastatic Cancer Oligoprogressive

Summary

A registry-based randomized phase II trial. A total of 46 patients with metastatic head and neck cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on treating physician decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions while continuing their current systemic therapy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether targeted, high-dose radiation (called SABR or stereotactic ablative radiotherapy) can help patients whose head and neck cancer has spread to a small number of areas (1–5 spots) and is no longer responding to systemic treatment like chemotherapy or immunotherapy. **You may be eligible if...** - You are 18 or older - You have metastatic head and neck squamous cell cancer (in the throat, mouth, nose, voice box, or related areas) - Your cancer has progressed (grown or spread) while on systemic treatment - Your cancer has spread to no more than 5 spots outside the brain, each smaller than 5 cm - You are in reasonably good physical condition (able to care for yourself) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have spinal cord compression - Your cancer has invaded the digestive tract (stomach, intestines, esophagus) - You have a medical condition that would prevent safe radiation or follow-up 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

OTHERStandard arm

Patients on the standard arm will be treated as per standard of care in our institution. Treatment options could include switching to next systemic therapy line, best supportive care or continuing on current systemic therapy.

RADIATIONExperimental arm

SABR to all oligoprogressive lesions + continuation of current systemic therapy