Comparing two types of radiation therapy for advanced head and neck cancer
A Phase III Randomized Controlled Trial Comparing Palliative Stereotactic Body Radiotherapy vs. Palliative Standard Radiotherapy in Patients With Advanced Head and Neck Cancer
This study tests if a new type of radiation therapy called SBRT can help people with advanced head and neck cancer better than the standard radiation treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 196 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Canadian Cancer Trials Group Research network |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 7 sites (Calgary, Alberta and 6 other locations) |
| Trial ID | NCT06641791 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed advanced mucosal squamous cell carcinoma of the head and neck who are unfit for curative intent radiation therapy.
Not a fit: Patients with early-stage head and neck cancer or those who are fit for curative treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with advanced head and neck cancer, potentially improving their quality of life and cancer control.
How similar studies have performed: Other studies have shown promising results with stereotactic body radiation therapy in various cancers, suggesting potential success for this approach in head and neck cancer as well.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Calgary, Alberta and 6 other locations
- Arthur J.E. Child Comprehensive Cancer Centre — Calgary, Alberta, Canada (Recruiting)
- Cross Cancer Institute — Edmonton, Alberta, Canada (Recruiting)
- CancerCare Manitoba — Winnipeg, Manitoba, Canada (Recruiting)
- Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (Recruiting)
- Odette Cancer Centre — Toronto, Ontario, Canada (Recruiting)
- University Health Network — Toronto, Ontario, Canada (Recruiting)
- CHUM-Centre Hospitalier de l'Universite de Montreal — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Wendy Parulekar
- Email: wparulekar@ctg.queensu.ca
- Phone: 613-533-6430
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.