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Clinical Trials in Canada / NCT06641791
Recruiting Phase 3

Palliative Steroeotactic Body Radiotherapy vs Palliative Standard Radiotherapy in Patients With Advanced Head and Neck Cancer

NCT06641791 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2025-04-07
Last updated
2026-09-15

Condition(s) studied

Advanced Head and Neck Cancer

Investigational drug(s) / intervention(s)

Standard Radiotherapy (SRT)Stereotactic Body Radiotherapy (SBRT)

Standard Radiotherapy (SRT): 2400 cGy in 3 fractions - day 0/7/21, OR, 2500 cGy in 5 fractions over 1 week

Stereotactic Body Radiotherapy (SBRT): 4500 cGy in 5 fractions (twice a week to primary and nodal GTV, OR, 4000 cGy in 5 fractions twice a week if organs at risk.

Study summary

This study is being done to answer the following question: Does stereotactic body radiation therapy (SBRT) provide better cancer control compared to standard radiation therapy (RT) for those with advanced head and neck cancer?

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Arthur J.E. Child Comprehensive Cancer Centre Calgary Alberta Recruiting
Cross Cancer Institute Edmonton Alberta Recruiting
BCCA - Vancouver Vancouver British Columbia Recruiting
CancerCare Manitoba Winnipeg Manitoba Recruiting
Ottawa Hospital Research Institute Ottawa Ontario Recruiting
Odette Cancer Centre Toronto Ontario Recruiting
University Health Network Toronto Ontario Recruiting
CHUM-Centre Hospitalier de l'Universite de Montreal Montreal Quebec Recruiting
Hotel-Dieu de Quebec Québec Quebec Recruiting

More Canadian Cancer Trials Group trials in Canada

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06641791 on ClinicalTrials.gov ↗ ← All trials in Canada