Recruiting
Phase 3

Stereotactic Body Radiotherapy vs. Standard Radiotherapy

Sponsor:

Canadian Cancer Trials Group

Code:

NCT06641791

Conditions

Advanced Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard Radiotherapy (SRT)

Stereotactic Body Radiotherapy (SBRT)

Study Details

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?

Conditions

Advanced Head and Neck Cancer

Study ID

NCT06641791

Start date

Apr 7, 2025

Status verified date

Jan, 2026

Completion date

Jun 1, 2031

Anticipated

Primary completion date

Jan 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

196 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Radiotherapy (SRT)

experimental: Stereotactic Body Radioterapy (SBRT)

Interventions

Standard Radiotherapy (SRT)

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

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.

Primary outcome measure

  • Overall Survival estimated according to Kaplan-Meier's methodology [ Time Frame: 6 years ]

Central Contacts and Locations

Central contacts

Wendy Parulekar

613-533-6430wparulekar@ctg.queensu.ca

Locations

Arthur J.E. Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Contacts

Robyn Banerjee

403 955-7641

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Contacts

Brock Debenham

780 432-8754

CancerCare Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Contacts

Carlton Johnny

204 787-2153

Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Ionut Busca

613 261-5398

Odette Cancer Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Ian D.T. Poon

416 480-4974

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Chiaojung Jillian Tsai

416 946-4501

CHUM-Centre Hospitalier de l'Universite de Montreal

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Houda Bahig

514 890-8000

Hotel-Dieu de Quebec

Recruiting

Québec, Quebec, Canada, G1R 2J6

More Information

Sponsor

Canadian Cancer Trials Group

Last update posted

Jul 14, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Canadian Cancer Trials Group on 2026-07-14.