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

NCT03768856 | Completed Results DMC FDA Device

• 1 other identifier: CASE4318
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer

Keywords

Radiation

Outcome Measures

Primary Outcomes (1)

• Feasibility of TFRT Planning and Delivery Defined by Number of Participants Starting Radiotherapy Within 15 Days of Simulation

  Number of participants starting radiotherapy within 15 days of simulation. The TFRT technique will be deemed feasible if 3/5 participants meet this criteria.

  15 days from start of treatment

Secondary Outcomes (5)

• Number of Participants Who Experienced Grade 3-5 Acute Toxicities Per CTCAE Version 4

  Up to 90 days after treatment

• Participant-reported Outcomes (PRO) During TFRT Using EORTC QLQ-C30 Questionnaire

  At weeks 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment

• Participant-reported Outcomes (PRO) During TFRT Using EORTC QLQ-H&N35 Questionnaire

  At weeks 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment

• Participant-reported Outcomes (PRO) of Mouth Dryness After TFRT Using Xerostomia Questionnaire

  At week 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment

• Number of Participants Considered Compliant With Plan Delivery

  5 months from start of treatment

Study Arms (1)

Temporally Feathered Radiation Therapy (TFRT)

EXPERIMENTAL

Temporally feathered radiation therapy is designed for targets within close proximity to multiple organs at risk. The foundation of this planning technique is the rotation of radiation dose to the nearby organs at risk on a daily basis, and hence the term "feathering".

Radiation: Temporally Feathered Radiation Therapy (TFRT)

Interventions

Temporally Feathered Radiation Therapy (TFRT) RADIATION

Up to 5 different plans are created and delivered on a daily basis Monday-Friday for 7 weeks. The treating physician designates up to 5 organs at risk (OARs) to be feathered based on the proximity to the target. The daily prescription dose delivered to the Planning Target Volumes (PTV) is not changed.

Temporally Feathered Radiation Therapy (TFRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Results Point of Contact

• Title: Dr Shlomo Koyfman
• Organization: Cleveland Clinic, Case Comprehensive Cancer Center

TaussigResearch@ccf.org

1-800-223-2273

Study Officials

• Nikhil Joshi, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: December 7, 2018
• Study Start: December 7, 2018
• Primary Completion: July 18, 2019
• Study Completion: December 3, 2019
• Last Updated: June 27, 2022
• Results First Posted: July 27, 2020

Record last verified: 2022-06

Locations

US (1)