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

Canadian Cancer Trials Group

Status and phase

Enrolling

Phase 3

Conditions

Advanced Head and Neck Cancer

Treatments

Radiation: Stereotactic Body Radiotherapy (SBRT)

Radiation: Standard Radiotherapy (SRT)

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT06641791

HN13

Details and patient eligibility

About

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?

Full 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.

Enrollment

196 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.