NCT05674396 3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial
| NCT ID | NCT05674396 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Head and Neck Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2023-06-30 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 108 participants in total. It began in 2023-06-30 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Jay Reddy, MD,PHD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT05674396 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05674396 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05674396 currently recruiting?
Yes, NCT05674396 is actively recruiting participants. Contact the research team at jreddy@mdanderson.org for enrollment information.
Where is the NCT05674396 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05674396 clinical trial?
NCT05674396 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Jay Reddy, MD,PHD at M.D. Anderson Cancer Center. The trial plans to enroll 108 participants.