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

NCT06641791 | Recruiting Phase 3 DMC

• 1 other identifier: HN13
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 8

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

Outcome Measures

Primary Outcomes (1)

• Overall Survival estimated according to Kaplan-Meier's methodology

  6 years

Secondary Outcomes (7)

• Progression-free Survival

  6 years

• Local Regional Failure Free Survival

  6 years

• Response Rate evaluated by RECIST

  6 years

• Number and Severity of Adverse Events

  6 years

• Patient Reported Outcomes utilizing PRO-CTCAE

  6 years

Study Arms (2)

Standard Radiotherapy (SRT)

ACTIVE COMPARATOR

Radiation: Standard Radiotherapy (SRT)

Stereotactic Body Radioterapy (SBRT)

EXPERIMENTAL

Radiation: Stereotactic Body Radiotherapy (SBRT)

Interventions

Standard Radiotherapy (SRT) RADIATION

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

Standard Radiotherapy (SRT)

Stereotactic Body Radiotherapy (SBRT) 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.

Stereotactic Body Radioterapy (SBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR): collaborator
• Canadian Cancer Trials Group: lead

Study Sites (8)

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada

RECRUITING

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

University Health Network

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ian Poon

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

  STUDY CHAIR

Central Study Contacts

Wendy Parulekar

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: April 7, 2025
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): June 1, 2031
• Last Updated: June 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8)