Stereotactic radiotherapy for patients with metastatic head and neck cancer showing limited progression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years
* Metastatic cancer (any histology), 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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Continuing systemic therapy after local treatment for metastatic breast cancer

  This study is testing if continuing treatment after local therapies can help people with metastatic breast cancer feel better and live longer.

  Recruiting at 7 sites Phase 2 The Netherlands Cancer Institute · Alkmaar and 6 other locations · NCT05301881

• IL-15–Enhanced NK Cell Therapy for Solid Tumors

  A first-in-human, early-phase study tests whether IL-15–enhanced engineered NK cells are safe and can show early signs of effect in adults with relapsed or metastatic solid tumors.

  Recruiting Early Phase 1 Genovn Therapeutics PTE. LTD. · Chongqing · NCT07621471

• LATTICE radiotherapy vs moderately dose-escalated palliative radiation for metastases

  This study tests whether LATTICE radiotherapy given in 5 fractions works better than a standard palliative dose for patients with metastatic cancer who have 1–2 sizable tumors.

  Recruiting Phase 2 Stanford University · Palo Alto, California · NCT07594431

• Givastomig with nivolumab and chemotherapy for CLDN18.2-positive metastatic stomach or gastroesophageal junction cancer

  This study will see if adding givastomig to nivolumab plus standard chemotherapy helps adults with CLDN18.2- and PD-L1-positive metastatic stomach or gastroesophageal junction cancer live longer without their disease getting worse.

  Recruiting at 5 sites Phase 2 I-Mab Biopharma US Limited · Goodyear, Arizona and 5 other locations · NCT07432295

• Support program for parents living with advanced cancer

  This study tests whether adding experiential sessions to a psycho-educational program helps parents with advanced cancer communicate better with their children aged 10–25.

  Recruiting Université Libre de Bruxelles · Anderlecht · NCT07341815

• POLARIS — Ablative radiotherapy with immunotherapy for people with multiple metastatic lesions

  This pilot tests whether giving focused high-dose radiation to up to 10 metastatic tumors while patients are on immunotherapy helps people with advanced solid tumors who have 3–10 metastases.

  Recruiting Phase 1 University of Illinois Chicago · Chicago, Illinois · NCT07269080

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.