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

M.D. Anderson Cancer Center

Status and phase: Enrolling; Phase 2

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Radiation: Traditional Palliation; Radiation: Stereotactic body radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05674396

2022-0648

NCI-2022-10828 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Traditional Palliation

Experimental group

Description:

Participant will be randomized to standard radiation

Treatment:

Radiation: Traditional Palliation

Stereotactic body radiotherapy (SBRT)

Experimental group

Description:

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

Treatment:

Radiation: Stereotactic body radiotherapy