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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Head and Neck Squamous Cell Carcinoma
Intervention / Treatment

-

Contacts and Locations

Houston

M D Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.D. Anderson Cancer Center,

Jay Reddy, MD,PHD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

2027-09-30