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NCT05674396 | RECRUITING | Head and Neck Squamous Cell Carcinoma

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

Condition or disease

Head and Neck Squamous Cell Carcinoma

Intervention/treatment

Stereotactic body radiotherapy

Traditional Palliation

Phase

PHASE2

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
Estimated Enrollment : 108 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial
Actual Study Start Date : 2023-06-30
Estimated Primary Completion Date : 2025-09-30
Estimated Study Completion Date : 2027-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial

Location Details

NCT05674396

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Locations

RECRUITING

United States, Texas

M D Anderson Cancer Center

Houston, Texas, United States, 77030