3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial

Phase 2

Recruiting

• Conditions: Head and Neck Squamous Cell Carcinoma

• Registration Number: NCT05674396
• Lead Sponsor: M.D. Anderson Cancer Center

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.

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.

Study Timeline

• Study First Submitted: 2022-12-21
• Study First Submitted QC: 2022-12-21
• Study First Posted: 2023-01-06
• Study Start: 2023-06-30
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-25
• Last Update Posted: 2025-07-28
• Primary Completion: 2025-09-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) Questionnaires	through study completion; an average of 1 year.	M. D. Anderson Symptom Inventory - Head \& Neck (MDASI-HN) score range from 0/10; (0-symptom has not been present)0 to 10 (10-the symptom was as bad as you can imagine it could be)

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States