Palliative Steroeotactic Body Radiotherapy vs Palliative Standard Radiotherapy in Patients With Advanced Head and Neck Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard Radiotherapy (SRT), Stereotactic Body Radiotherapy (SBRT).
- Who it may be relevant to
- Registry conditions: Advanced Head and Neck Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Radiation Standard Radiotherapy (SRT)
2400 cGy in 3 fractions - day 0/7/21, OR, 2500 cGy in 5 fractions over 1 week - 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.
Primary outcome measures
- Overall Survival estimated according to Kaplan-Meier's methodology [Time frame: 6 years]
Secondary outcome measures (7)
- Progression-free Survival [Time frame: 6 years]
- Local Regional Failure Free Survival [Time frame: 6 years]
- Response Rate evaluated by RECIST [Time frame: 6 years]
- Number and Severity of Adverse Events [Time frame: 6 years]
- Patient Reported Outcomes utilizing PRO-CTCAE [Time frame: 6 years]
- Patient Reported Outcomes utilizing FACT-HN [Time frame: 6 years]
- Healthcare Resource Utilization utilizing EQ-5D-5L [Time frame: 6 years]
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 9 centers
- Arthur J.E. Child Comprehensive Cancer Centre — Calgary
- Cross Cancer Institute — Edmonton
- BCCA - Vancouver — Vancouver
- CancerCare Manitoba — Winnipeg
- Ottawa Hospital Research Institute — Ottawa
- Odette Cancer Centre — Toronto
- University Health Network — Toronto
- CHUM-Centre Hospitalier de l'Universite de Montreal — Montreal
- … and 1 more center
Identifiers
NCT: NCT06641791 · HN13