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

A Phase III Randomized Controlled Trial Comparing Palliative Stereotactic Body Radiotherapy vs. Palliative Standard Radiotherapy in Patients With Advanced Head and Neck Cancer

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?

Study Overview

• Status: Recruiting
• Conditions: Advanced Head and Neck Cancer
• Intervention / Treatment: Radiation: Standard Radiotherapy (SRT); Radiation: Stereotactic Body Radiotherapy (SBRT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 196
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Wendy Parulekar; Phone Number: 613-533-6430; Email: wparulekar@ctg.queensu.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 5G2
      • Recruiting
      • Arthur J.E. Child Comprehensive Cancer Centre
      • Contact: Robyn Banerjee; Phone Number: 403 955-7641
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Recruiting
      • Cross Cancer Institute
      • Contact: Brock Debenham; Phone Number: 780 432-8754
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • Recruiting
      • CancerCare Manitoba
      • Contact: Carlton Johnny; Phone Number: 204 787-2153
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • Ottawa Hospital Research Institute
      • Contact: Ionut Busca; Phone Number: 613 261-5398
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • University Health Network
      • Contact: Chiaojung Jillian Tsai; Phone Number: 416 946-4501
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Odette Cancer Centre
      • Contact: Ian D.T. Poon; Phone Number: 416 480-4974
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • Recruiting
      • CHUM-Centre Hospitalier de l'Universite de Montreal
      • Contact: Houda Bahig; Phone Number: 11185 514 890-8000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Radiotherapy (SRT)	Radiation: Standard Radiotherapy (SRT); 2400 cGy in 3 fractions - day 0/7/21, OR, 2500 cGy in 5 fractions over 1 week
Experimental: Stereotactic Body Radioterapy (SBRT)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival estimated according to Kaplan-Meier's methodology	6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival		6 years
Local Regional Failure Free Survival	defined as the time from the date of randomization to the date of any of the following, whichever comes first: The first record of appearance (radiological or clinical) of local or regional disease progression/recurrence.; Surgery of primary tumour at any time performed for clinical or radiological (RECIST 1.1) disease persistence/progression/recurrence with tumour present/unknown on final pathology.; Neck dissection > 20 weeks from the end of radiation therapy performed for clinical or radiological (RECIST 1.1) disease persistence/progression/recurrence with tumour present/unknown on final pathology.	6 years
Response Rate evaluated by RECIST		6 years
Number and Severity of Adverse Events		6 years
Patient Reported Outcomes utilizing PRO-CTCAE	We will qualitatively compare PRO-CTCAE item scores between arms at 8 weeks from the start of RT, and examine PRO-CTCAE item scores at 12 months post-RT in the SBRT arm, as an indicator or persisting (consequential or "late") RT toxicity with SBRT to the head and neck region.	6 years
Patient Reported Outcomes utilizing FACT-HN	proportion of patients between arms who have a meaningful worsening (12 points or greater) of QOL	6 years
Healthcare Resource Utilization utilizing EQ-5D-5L	All enrolled participants who have received at least one fraction of protocol therapy are evaluable for health economics. Those who have completed the Health Utilities Index (EQ-5D-5L), will be evaluable for cost-utility analyses.	6 years

Collaborators and Investigators

• Sponsor: Canadian Cancer Trials Group
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Study Chair: Ian Poon, Odette Cancer Centre, Sunnybrook Health Sciences, UHN, Toronto, ON Canada

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2025
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): June 1, 2031

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Radiosurgery
• Other Study ID Numbers: HN13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: As per CCTG Policy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No