Temporally Feathered Radiation Therapy (TFRT) for Head and Neck Squamous Cell Carcinoma

Completed · Not applicable

Conditions studied: Head and Neck Cancer

In brief

This study will evaluate the feasibility of using more advanced IMRT (intensity modulated radiation therapy) techniques. This new technique is termed Temporally Feathered Radiation Therapy (TFRT). TFRT is designed to reduce the side effects of conventional radiation therapy. Research has shown that TFRT may lessen these side effects.

Key facts

Study ID

NCT03768856

Run by

Case Comprehensive Cancer Center

People needed

5

Starts

2018-12-07

Expected to finish

2019-12-03

Last updated by the study team

2022-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must have histologically or cytologically confirmed squamous cell carcinoma arising from a primary head and neck site (oral cavity, oropharynx, larynx/hypopharynx, nasopharynx).TX-4, NX-3, MX-0 stages are permitted.
• Subjects must be eligible for definitive radiation therapy (70Gy in 35 fractions) with or without chemotherapy.
• Karnofsky Performance status ≥80.
• Subjects must have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

• Subjects receiving any other investigational agents.
• Postoperative radiotherapy is not permitted.
• History of prior head and neck radiation therapy.
• Subjects with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant or breastfeeding women are excluded from this study because radiation therapy has the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with radiation therapy, breastfeeding should be discontinued if the mother is treated with radiation therapy. These potential risks may also apply to other agents used in this study.
• The patient cannot have distant metastatic disease (or M1 disease by AJCC 8th edition).

Where it is running

• Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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