Clinical trial NCT06641791: Palliative Steroeotactic Body Radiotherapy vs Palliative Standard Radiotherapy in Patients With Advanced Head and Neck Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Advanced Head and Neck Cancer
Lead sponsor: Canadian Cancer Trials Group
Sponsor class: NETWORK
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2024-10-15
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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.

Eligibility 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.

Primary outcomes:
measure: Overall Survival estimated according to Kaplan-Meier's methodology
timeFrame: 6 years
Secondary outcomes:
measure: Progression-free Survival
timeFrame: 6 years
measure: Local Regional Failure Free Survival
timeFrame: 6 years
measure: Response Rate evaluated by RECIST
timeFrame: 6 years
measure: Number and Severity of Adverse Events
timeFrame: 6 years
measure: Patient Reported Outcomes utilizing PRO-CTCAE
timeFrame: 6 years
measure: Patient Reported Outcomes utilizing FACT-HN
timeFrame: 6 years
measure: Healthcare Resource Utilization utilizing EQ-5D-5L
timeFrame: 6 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Odette Cancer Centre
state: Ontario
Study officials:
affiliation: Odette Cancer Centre, Sunnybrook Health Sciences, UHN, Toronto, ON Canada
name: Ian Poon
role: STUDY_CHAIR
References: