Clinical trial NCT05674396: 3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial
Official title: 3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) Questionnaires
timeFrame: through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jay Reddy, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: