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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
46
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.
SABR to all oligoprogressive lesions + continuation of current systemic therapy
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
RECRUITINGProgression free survival
PFS defined from randomization to disease progression at any site or death
Time frame: 5 years
Overall survival
OS defined as time from randomization to time of death from any cause.
Time frame: 5 years
Quality of life Measured using the FACT-G tool, head and neck cancer-related patient reported outcome- CTCAE (PRO-CTCAE) and Quality of life 5-level EQ-5D
Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE) and quality of life 5-level EQ-5D
Time frame: 5 years
Grade ≥ 3 toxicity Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Measured using the Common Terminology Criteria for Adverse Events
Time frame: 5 years
Local control
Defined as time from the end of SABR treatment to date of local failure and will be measured only in the experimental arm
Time frame: 5 years
Time to next systemic therapy
Defined as time from randomization to time of subsequent therapy line
Time frame: 5 years
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