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

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

NCT ID: NCT06641791

Condition: Advanced Head and Neck Cancer

Conditions: Official terms:
Head and Neck Neoplasms

Study type: Interventional

Study phase: Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Standard Radiotherapy (SRT)
Description: 2400 cGy in 3 fractions - day 0/7/21, OR, 2500 cGy in 5 fractions over 1 week
Arm group label: Standard Radiotherapy (SRT)

Intervention type: Radiation
Intervention name: Stereotactic Body Radiotherapy (SBRT)
Description: 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.
Arm group label: Stereotactic Body Radioterapy (SBRT)

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?

Detailed description: Stereotactic body radiation therapy, or SBRT, is a cancer treatment that more precisely delivers radiation to the tumour area with less radiation going to unaffected areas around the tumour. It uses fewer treatments of higher doses compared to standard radiation therapy. This study is being done to find out if this approach is better than the usual approach for advanced head and neck cancer. The usual approach is defined as care most people get for advanced head and neck cancer.

Criteria for eligibility:
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 T0-T4/N0-N3 - Must be considered unfit for curative intent RT as determined by the treating oncologist(s) - Geriatric 8 score <14 (see Appendix VI for G8 Screening Tool) - Patient must be ≥18 years of age - 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). - Gross tumour poorly visualized on CT/MRI. - Definitive radiological or clinically evident distant metastases. - Scleroderma/CREST syndrome.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: January 1, 2025

Completion date: June 1, 2031

Lead sponsor:
Agency: Canadian Cancer Trials Group
Agency class: Other

Collaborator:
Agency: Canadian Institutes of Health Research (CIHR)
Agency class: Other

Source: Canadian Cancer Trials Group

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06641791