Short-course radiation therapy for oropharynx 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 clinical trial compares the outcomes of a short-course chemoradiation approach using stereotactic boost to the tumor and de-escalated chemoradiation to the neck against the standard 7-week chemoradiation regimen for patients with HPV-associated oropharynx cancer. The study aims to reduce treatment duration and associated toxicities while maintaining efficacy. By utilizing stereotactic ablative radiotherapy (SABR), the trial seeks to deliver precise radiation doses, minimizing exposure to surrounding healthy tissues. The goal is to improve patient quality of life and treatment outcomes in this specific cancer population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years
* Ability to provide written informed consent.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx.
* Positive for HPV by p16 immunohistochemistry (IHC) or HPV in-situ hybridization (ISH)
* Clinical stage T1-3, N1 M0 (Stage I-II) as per AJCC 8th edition.
* Primary tumor \< 30 cc
* Planned for curative chemoradiation
* For females of child-bearing age, a negative pregnancy test

Exclusion Criteria:

* Clinical N3 classification, as per AJCC 8th edition
* Clinically overt extranodal extension (ENE). As per AJCC 8th edition, clinically overt ENE is defined as invasion of the skin, infiltration of musculature/fixation to adjacent structures on clinical examination, cranial nerve, brachial plexus, sympathetic trunk or phrenic nerve invasion with dysfunction).
* Previous irradiation of the head and neck region
* Previous surgery of the HNC region (except for incisional or excisional biopsies)
* Pregnancy or breastfeeding
* Connective tissue disease
* Any medical condition that could, in the opinion of the investigator, prevent follow-up after radiotherapy.
* Non-Cisplatin concurrent chemotherapy
* Prior induction chemotherapy

Where it's running

• London Health Sciences Center
  London, Ontario, Canada Recruiting
• Centre Hospitalier de l'Université de Montréal
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: David Palma, MD PhD — London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
• Study coordinator: Diane Trudel
• Email: diane.dt.chum@ssss.gouv.qc.ca
• Phone: 514-890-8254

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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.