Recruiting
Phase 2

FrAction Stereotactic Body Radiation Therapy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05674396

Conditions

Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic body radiotherapy

Traditional Palliation

Study Details

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Study ID

NCT05674396

Start date

Jun 30, 2023

Status verified date

Aug, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Traditional Palliation

Participant will be randomized to standard radiation

experimental: Stereotactic body radiotherapy (SBRT)

Participants will be randomized to receive (SBRT) Stereotactic body radiotherapy.

Interventions

Stereotactic body radiotherapy

Participants will receive radiation as per the schedule discussed with the study doctor.

Traditional Palliation

Participants will receive radiation as per the schedule discussed with the study doctor.

Primary outcome measure

  • M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) Questionnaires [ Time Frame: through study completion; an average of 1 year. ]

Central Contacts and Locations

Central contacts

Jay Reddy, MD,PHD

(832) 750-2924jreddy@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Jay Reddy, MD, PHD

832-750-2924jreddy@mdanderson.org

Principal Investigator:

Jay Reddy, MD, PHD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-10.