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NCT06641791 | NOT YET RECRUITING | Advanced Head and Neck Cancer

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

Canadian Cancer Trials Group

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?

Condition or disease

Advanced Head and Neck Cancer

Intervention/treatment

Standard Radiotherapy (SRT)

Stereotactic Body Radiotherapy (SBRT)

Phase

PHASE3

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
Estimated Enrollment : 196 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase III Randomized Controlled Trial Comparing Palliative Stereotactic Body Radiotherapy vs. Palliative Standard Radiotherapy in Patients With Advanced Head and Neck Cancer
Actual Study Start Date : 2025-01-01
Estimated Primary Completion Date : 2031-01-01
Estimated Study Completion Date : 2031-06-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 T0-T4/N0-N3
  • * Must be considered unfit for curative intent RT as determined by the treating oncologist(s)
  • * Geriatric 8 score \<14 (see Appendix VI for G8 Screening Tool)
  • * Patient must be ≥18 years of age
  • * 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).
  • * Gross tumour poorly visualized on CT/MRI.
  • * Definitive radiological or clinically evident distant metastases.
  • * Scleroderma/CREST syndrome.
Palliative Steroeotactic Body Radiotherapy vs Palliative Standard Radiotherapy in Patients With Advanced Head and Neck Cancer

Location Details

NCT06641791

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