Palliative Steroeotactic Body Radiotherapy vs Palliative Standard Radiotherapy in Patients With 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
Canadian Cancer Trials Group
196 participants
Apr 7, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria10
- 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 Criteria9
- 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.
Interventions
2400 cGy in 3 fractions - day 0/7/21, OR, 2500 cGy in 5 fractions over 1 week
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.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06641791