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

NCT ID: NCT06641791

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-07
• Study Completion Date: 2031-06-01

Brief 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.

Conditions

Advanced Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Radiotherapy (SRT)

Group Type: ACTIVE_COMPARATOR

Standard Radiotherapy (SRT)

Intervention Type: RADIATION

2400 cGy in 3 fractions - day 0/7/21, OR, 2500 cGy in 5 fractions over 1 week

Stereotactic Body Radioterapy (SBRT)

Group Type: EXPERIMENTAL

Stereotactic Body Radiotherapy (SBRT)

Intervention Type: RADIATION

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.

Interventions

Standard Radiotherapy (SRT)

2400 cGy in 3 fractions - day 0/7/21, OR, 2500 cGy in 5 fractions over 1 week

Intervention Type: RADIATION

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.

Intervention Type: RADIATION

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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Canadian Cancer Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian Poon

Role: STUDY_CHAIR

Odette Cancer Centre, Sunnybrook Health Sciences, UHN, Toronto, ON Canada

Locations

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status: RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Site Status: RECRUITING

Odette Cancer Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Wendy Parulekar

Role: CONTACT

wparulekar@ctg.queensu.ca

613-533-6430

Facility Contacts

Brock Debenham

Role: primary

780 432-8754

Ionut Busca

Role: primary

613 261-5398

Ian D.T. Poon

Role: primary

416 480-4974

Houda Bahig

Role: primary

514 890-8000 ext. 11185

Other Identifiers

HN13

Identifier Type: -

Identifier Source: org_study_id