Comparing two types of radiation therapy for advanced head and neck cancer

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 study aims to determine whether stereotactic body radiation therapy (SBRT) offers better cancer control than standard radiation therapy (RT) for patients with advanced head and neck cancer. SBRT delivers radiation more precisely to the tumor while minimizing exposure to surrounding healthy tissue, using fewer sessions with higher doses compared to standard RT. The study will involve patients who are deemed unfit for curative treatment and will assess the effectiveness of these two approaches in managing their condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed mucosal squamous cell carcinoma (SCC) of the head and neck arising from at least one of the following sites: oro/hypopharynx, oral cavity, supraglottic larynx, maxillary sinus, nasal cavity, or unknown primary
* Stages TX or T0-T4/N0-N3
* Must be considered unfit for curative intent RT as determined by the treating oncologist(s)
* Geriatric 8 score \<14
* Patient must be ≥18 years of age
* Staging CT or MRI of the head and neck within 8 weeks prior to randomization
* Chest CT or x-ray. PET CT is permitted if CT is of diagnostic quality.
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3
* Participants of childbearing potential must have agreed to use a highly effective contraceptive method during protocol therapy.
* Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational treatment are eligible for this trial.

Exclusion Criteria:

* Patients with nasopharyngeal carcinoma.
* Prior systemic therapy (including immunotherapy).
* Prior radiotherapy to the head and neck excluding superficial radiotherapy for head and neck skin cancer that does not overlap with current protocol treatment.
* Prior head and neck cancer excluding skin cancer.
* Patients with tumour locations/at risk of SBRT toxicity, including glottic/subglottic larynx, T4 hypopharynx, post-cricoid, cervical esophagus, circumferential pharyngeal involvement, extension/proximity to brain/optic structures, any single tumour mass \>8 cm (in one dimension).
* \> 2 nodal levels (Level 1a/b not counted); retropharyngeal lymph nodes (where the closest edge is \< 2cm from the closest edge of CTV (primary or nodal) will not be considered as a different level). Note: a single lymph node mass that spans 2 levels will be considered as 1 level.
* Gross tumour poorly visualized on CT/MRI.
* Definitive radiological or clinically evident distant metastases.
* Scleroderma/CREST syndrome.

Where it's running

• Arthur J.E. Child Comprehensive Cancer Centre
  Calgary, Alberta, Canada Recruiting
• Cross Cancer Institute
  Edmonton, Alberta, Canada Recruiting
• BCCA - Vancouver
  Vancouver, British Columbia, Canada Recruiting
• CancerCare Manitoba
  Winnipeg, Manitoba, Canada Recruiting
• Juravinski Cancer Centre at Hamilton Health Sciences
  Hamilton, Ontario, Canada Recruiting
• Ottawa Hospital Research Institute
  Ottawa, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Wendy Parulekar
• Email: wparulekar@ctg.queensu.ca
• Phone: 613-533-6430

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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.