Stereotactic radiotherapy for patients with metastatic head and neck cancer showing limited progression
Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer: A Phase II Randomized Trial
This study is testing if a special type of targeted radiation therapy can help people with metastatic head and neck cancer who are seeing limited disease progression while on other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT04989725 on ClinicalTrials.gov |
What this trial studies
This phase II trial aims to evaluate the effectiveness of stereotactic ablative radiotherapy (SABR) in patients with metastatic head and neck cancer who are experiencing oligoprogression while on systemic therapy. A total of 46 patients will be randomized into two groups: one receiving standard care and the other receiving SABR targeting all oligoprogressive lesions, while continuing their current systemic treatment. The study will assess the potential benefits of SABR in controlling disease progression compared to standard treatment options.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with biopsy-proven metastatic head and neck squamous cell carcinoma and oligoprogression to 1-5 extracranial lesions.
Not a fit: Patients with extensive metastatic disease beyond the oligoprogressive lesions or those who cannot safely undergo stereotactic ablative radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option that may improve disease control and outcomes for patients with oligoprogressive metastatic head and neck cancer.
How similar studies have performed: While there is ongoing research in the field, this specific approach using SABR for oligoprogressive disease in metastatic head and neck cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where this trial is running
Montreal, Quebec
- Centre Hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Silvine Benth
- Email: silvine.benth.chum@ssss.gouv.qc.ca
- Phone: 514-890-8254
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.