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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Radiation: Traditional Palliation; Radiation: Stereotactic body radiotherapy

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 Type: Interventional
• Enrollment (Estimated): 108
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jay Reddy, MD,PHD; Phone Number: (832) 750-2924; Email: jreddy@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Jay Reddy, MD, PHD; Phone Number: 832-750-2924; Email: jreddy@mdanderson.org
      • Principal Investigator: Jay Reddy, MD, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Traditional Palliation; Participant will be randomized to standard radiation	Radiation: Traditional Palliation; Participants will receive radiation as per the schedule discussed with the study doctor.
Experimental: Stereotactic body radiotherapy (SBRT); Participants will be randomized to receive (SBRT) Stereotactic body radiotherapy.	Radiation: Stereotactic body radiotherapy; Participants will receive radiation as per the schedule discussed with the study doctor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) Questionnaires	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)	through study completion; an average of 1 year.

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Jay Reddy, MD,PHD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: December 21, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): January 6, 2023

Study Record Updates

• Last Update Posted (Actual): August 10, 2026
• Last Update Submitted That Met QC Criteria: August 7, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Radiosurgery
• Other Study ID Numbers: 2022-0648; NCI-2022-10828 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No