Short-course radiation therapy for oropharynx cancer
Stereotactic Boost and SHOrt-course Radiation Therapy for HPV-associated OroPharynx Cancer Trial: A Randomized Multicentric Phase III Trial
This study is testing a shorter and more targeted radiation treatment for people with HPV-related throat cancer to see if it can reduce side effects while still being effective.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (London, Ontario and 1 other locations) |
| Trial ID | NCT04178174 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with biopsy-proven HPV-positive squamous cell carcinoma of the oropharynx, staged T1-3, N1 M0.
Not a fit: Patients with advanced clinical N3 classification or previous head and neck irradiation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to reduced treatment duration and lower toxicity for patients with oropharynx cancer.
How similar studies have performed: Previous studies have shown promising results with similar de-escalation strategies in HPV-positive oropharynx cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
London, Ontario and 1 other locations
- 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
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.