Palliative Steroeotactic Body Radiotherapy vs Palliative Standard Radiotherapy in Patients With A… (NCT06641791) | Clinical Trial Compass
RecruitingPhase 3
Palliative Steroeotactic Body Radiotherapy vs Palliative Standard Radiotherapy in Patients With Advanced Head and Neck Cancer
Canada196 participantsStarted 2025-04-07
Plain-language 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?
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pharynge…
What they're measuring
1
Overall Survival estimated according to Kaplan-Meier's methodology