Advanced radiation treatment for head and neck cancer palliation
3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial
This study is testing if a new type of radiation treatment can help relieve symptoms and improve quality of life for patients with head and neck cancer who can't be cured.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05674396 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of stereotactic body radiation therapy (SBRT) in providing palliative care for patients with head and neck squamous cell carcinoma who are not eligible for curative treatment. The study compares local progression-free survival, pain response, symptom burden, toxicity, local control, and overall survival between SBRT and traditional radiation methods. Participants will receive either SBRT or standard palliative radiation, with their outcomes monitored over time to assess the benefits of the advanced technique.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with histologically confirmed head and neck squamous cell carcinoma who are ineligible for curative treatment.
Not a fit: Patients with contraindications to radiotherapy or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide more effective pain relief and improved quality of life for patients with advanced head and neck cancer.
How similar studies have performed: Previous studies have shown promising results with stereotactic radiation techniques in various cancers, suggesting potential success for this novel application in head and neck cancer.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Jay Reddy, MD,PHD — M.D. Anderson Cancer Center
- Study coordinator: Jay Reddy, MD,PHD
- Email: jreddy@mdanderson.org
- Phone: (832) 750-2924
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.