Actively Recruiting
Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2023-12-12
46
Participants Needed
1
Research Sites
321 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Biopsy confirmed head and neck squamous cell carcinoma (including oropharynx, oral cavity, nasopharynx, sinonasal, larynx, or hypopharynx)
- Metastatic disease confirmed by pathology or imaging
- Able to provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Progressive disease on any line of systemic treatment, defined by RECIST 1.1 criteria as over 20% increase in lesion size, new lesions, or unequivocal progression on CT
- Oligoprogression involving 1 to 5 extracranial lesions no larger than 5 cm, affecting up to 3 organs
- Progression at the primary tumor site counts within the 5 lesions
- Lymph node metastases each counted as one site
- All disease sites safely targetable with stereotactic ablative radiotherapy as judged by the investigator
- Patients with prior metastases treated with ablative therapies (radiotherapy, surgery, radiofrequency ablation) before current systemic therapy are eligible
You will not qualify if you...
- Pregnancy or breastfeeding
- Any medical condition that could prevent radiotherapy or follow-up as judged by the investigator
- Presence of spinal cord compression
- Metastatic disease invading the gastrointestinal tract (esophagus, stomach, small or large bowel)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
Research Team
S
Silvine Benth
CONTACT
M
Mom Phat
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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