Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer
- Conditions
- Head and Neck CancerOligoprogressiveMetastatic Cancer
- Interventions
- Radiation: Experimental armOther: Standard arm
- Registration Number
- NCT04989725
- Lead Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 46
- Age ≥18 years
- Biopsy proven HNSCC (oropharynx, oral cavity, nasopharynx, sinonasal, larynx or hypopharynx)
- Metastatic HNSCC, with pathological or radiological proof of metastasis
- Ability to provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Progressive disease while on systemic treatment (any line), defined as per RECIST criteria 1.1 on CT metrics as a greater than 20% increase in the sum measurement of lesions, non-target unequivocal progressive disease or a new lesion on CT.
- Oligoprogression to 1-5 extracranial lesions ≤ 5cm and involving ≤ 3 organs. Progression at the primary tumor site should be counted within the total of 5 lesions. For patients with lymph node metastases, each node is counted as one site of metastasis.
- All sites of disease can, in the opinion of the investigator, be safely treated and targetable with SABR (taking into account prior local therapy, organ function and underlying medical condition such as inflammatory bowel disease, pulmonary fibrosis, etc.)
- Patients with prior metastases that have been treated with ablative therapies (e.g. radiotherapy, surgery or radiofrequency ablation) before their current line of systemic therapy, are eligible.
- Pregnancy or breastfeeding
- Any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy.
- Presence of spinal cord compression
- Metastatic disease that invades the GI tract (including esophagus, stomach, small or large bowel
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental SABR arm Experimental arm Definitive SABR to oligoprogressive lesions + continue current systemic therapy Standard of care Standard arm Switch to subsequent systemic therapy line, best supportive care or continue current systemic line
- Primary Outcome Measures
Name Time Method Progression free survival 5 years PFS defined from randomization to disease progression at any site or death
- Secondary Outcome Measures
Name Time Method Overall survival 5 years OS defined as time from randomization to time of death from any cause.
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 5 years Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE) and quality of life 5-level EQ-5D
Grade ≥ 3 toxicity Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0) 5 years Measured using the Common Terminology Criteria for Adverse Events
Time to next systemic therapy 5 years Defined as time from randomization to time of subsequent therapy line
Local control 5 years Defined as time from the end of SABR treatment to date of local failure and will be measured only in the experimental arm
Trial Locations
- Locations (1)
Centre Hospitalier de l'Université de Montréal
🇨🇦Montréal, Quebec, Canada