3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial
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: Stereotactic body radiotherapy, Traditional Palliation.
- Who it may be relevant to
- Registry conditions: Head and Neck Squamous Cell Carcinoma. 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
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
To learn if it is effective to use advanced radiation treatment techniques (stereotactic radiation or "SBRT") to safely deliver a strong dose of radiation to your tumor in a shorter period of time than would typically be feasible with traditional methods.
Detailed description
Objectives:
* To compare local progression-free survival following palliation with SBRT versus traditional fractionations in patients with HN SCC deemed ineligible for curative-intent treatment. * To compare pain response, symptom burden, toxicity, local control, progression-free survival, and overall survival between the treatment modalities.
Interventions
- Radiation Stereotactic body radiotherapy
Participants will receive radiation as per the schedule discussed with the study doctor. - Radiation Traditional Palliation
Participants will receive radiation as per the schedule discussed with the study doctor.
Primary outcome measures
- M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) Questionnaires [Time frame: through study completion; an average of 1 year.]
Eligibility criteria
Inclusion criteria
- Age 18 or older
- Willing to provide informed consent
- Histologically confirmed squamous cell carcinoma
- Primary tumor site in the head and neck (includes oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, salivary gland, and cutaneous subsites as well as tumors of unknown primary site)
- Ineligible for curative intent treatment after multidisciplinary evaluation (including evaluation by radiation oncologist and surgeon followed by presentation at multidisciplinary tumor board prior to randomization)
- Prior therapy including radiation, surgery, or systemic therapy is permitted unless further radiation is deemed inappropriate by the enrolling physician
- Metastatic disease is permitted
Exclusion criteria
- Contraindications to radiotherapy
- Pregnant or lactating women
5.0 PRE-TREATMENT EVALUATION
- History and physical examination including laryngopharyngoscopy by a radiation oncologist and/or head and neck surgeon within 8 weeks prior to randomization.
o Clinical examination will include a detailed description of disease target including measurement where feasible to facilitate response assessment
- Documentation of smoking history
- Staging imaging within 12 weeks prior to randomization:
- Contrast-enhanced CT of the neck and chest or
- MRI of the neck with CT of the chest or
- Whole body PET/CT
- Histological confirmation of squamous cell carcinoma
- Pregnancy test for women of child-bearing age, within 2 weeks prior to randomization
- Assessment of all baseline symptoms, using CTCAE version 5.0 within 2 weeks prior to randomization.
- Assessment of baseline pain score (NRS) and analgesic use (non-opioid and opioid)
- Completion of QOL scoring within 2 weeks of randomization
- Informed consents must be obtained prior to any study specific activities
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
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT05674396 · 2022-0648 · NCI-2022-10828