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

Head and Neck Squamous Cell Carcinoma Clinical 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05674396
• Other study ID #: 2022-0648
• Secondary ID: NCI-2022-10828
• Status: Recruiting
• Phase: Phase 2
• Start date: June 30, 2023
• Est. completion date: September 30, 2027

Study information

• Verified date: June 2024
• Source: M.D. Anderson Cancer Center
• Contact: Jay Reddy, MD,PHD
• Phone: (832) 750-2924
• Email: jreddy[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: September 30, 2027
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) Questionnaires	M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) score range from 0/10; (0-symptom has not been present)0 to 10 (10-the symptom was as bad as you can imagine it could be)	through study completion; an average of 1 year.

External Links

•   MD Anderson Cancer Center