Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06641791

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

Led by Canadian Cancer Trials Group · Updated on 2026-05-12

196

Participants Needed

7

Research Sites

320 weeks

Total Duration

On this page

Sponsors

C

Canadian Cancer Trials Group

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is 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?

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed mucosal squamous cell carcinoma of the head and neck from oro/hypopharynx, oral cavity, supraglottic larynx, maxillary sinus, nasal cavity, or unknown primary
  • Stages TX or T0-T4/N0-N3
  • Considered unfit for curative intent radiation therapy by treating oncologist(s)
  • Geriatric 8 score less than 14
  • At least 18 years of age
  • Staging CT or MRI of head and neck within 8 weeks before randomization
  • Chest CT or X-ray; PET CT allowed if diagnostic quality
  • ECOG Performance Status 0 to 3
  • Use of highly effective contraception if of childbearing potential
  • Prior malignancy allowed if it does not interfere with safety or efficacy assessment
Not Eligible

You will not qualify if you...

  • Nasopharyngeal carcinoma
  • Prior systemic therapy including immunotherapy
  • Prior radiotherapy to head and neck except superficial skin cancer radiotherapy not overlapping current treatment
  • Prior head and neck cancer excluding skin cancer
  • Tumor locations or risks for SBRT toxicity including glottic/subglottic larynx, T4 hypopharynx, post-cricoid, cervical esophagus, circumferential pharyngeal involvement, extension near brain or optic structures, any tumor mass over 8 cm
  • More than 2 nodal levels involved (Level 1a/b not counted); retropharyngeal lymph nodes less than 2 cm from treatment area not counted as different level
  • Gross tumor poorly visible on CT or MRI
  • Definite radiological or clinical distant metastases
  • Scleroderma or CREST syndrome

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada, T2N 5G2

Actively Recruiting

2

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

Actively Recruiting

3

CancerCare Manitoba

Winnipeg, Manitoba, Canada, R3E 0V9

Actively Recruiting

4

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada, K1H 8L6

Actively Recruiting

5

Odette Cancer Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

6

University Health Network

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

7

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada, H2X 3E4

Actively Recruiting

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Research Team

W

Wendy Parulekar

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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