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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | Active Comparator | Switch to subsequent systemic therapy line, best supportive care or continue current systemic line |
|
| Experimental SABR arm | Experimental | Definitive SABR to oligoprogressive lesions + continue current systemic therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard arm | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | PFS defined from randomization to disease progression at any site or death | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | OS defined as time from randomization to time of death from any cause. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silvine Benth | Contact | 514-890-8254 | silvine.benth.chum@ssss.gouv.qc.ca | |
| Mom Phat | Contact | 514-890-8254 | mom.phat.chum@ssss.gouv.qc.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de l'Université de Montréal | Recruiting | Montreal | Quebec | H2X 3E4 | Canada |
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Randomized screening phase II trial
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| Experimental arm | Radiation | SABR to all oligoprogressive lesions + continuation of current systemic therapy |
|
Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE) and quality of life 5-level EQ-5D |
| 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 | 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 | 5 years |
| Time to next systemic therapy | Defined as time from randomization to time of subsequent therapy line | 5 years |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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