NCT04989725

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer
• Metastatic Cancer
• Oligoprogressive

Interventions

Type	Name	Description
OTHER	Standard 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.
RADIATION	Experimental arm	SABR to all oligoprogressive lesions + continuation of current systemic therapy

Timeline

• Start date: 2021-10-01
• Primary completion: 2025-12-01
• Completion: 2027-12-01
• First posted: 2021-08-04
• Last updated: 2023-12-12

Locations

1 site across 1 country: Canada