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New treatment option for Head and Neck Cancer
Official title Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer
ClinicalTrials.gov ID: NCT04989725
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.