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

Primary Purpose

Head and Neck Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Temporally Feathered Radiation Therapy (TFRT)

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Radiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Sites / Locations

Cleveland Clinic, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Temporally Feathered Radiation Therapy (TFRT)

Arm Description

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".

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Number of participants who experienced grade 3-5 acute toxicities as defined by CTCAE version 4

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

Global health status/health-related quality of life measurements based on European Organization of Research and Treatment Of Cancer tool general (EORTC QLQ-H&N35). Scores range from 0-100.

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

Health-related quality of life measurements and symptoms among head and neck cancer participants based on European Organization of Research and Treatment of Head and Neck cancer questionnaire (EORTC QLQ-C30). Scores range from 0-100.

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

Xerostomia Questionnaire is a questionnaire used to describe mouth dryness and its effects on daily life. Scores range from 0-100. A high score represents a worse Xerostomia.

Number of Participants Considered Compliant With Plan Delivery

Number of participants who were able to complete the treatment course within the allotted time and without deviations and complete the questionnaires within the allotted time. Considered successful if 3/5 complete prescribed treatment course per protocol.

Full Information

NCT ID

NCT03768856

First Posted

November 13, 2018

Last Updated

June 1, 2022

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT03768856

Brief Title

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

Official Title

Feasibility Study of Temporally Feathered Radiation Therapy (TFRT) for Head and Neck Squamous Cell Carcinoma: Means of Toxicity Reduction

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

December 7, 2018 (Actual)

Primary Completion Date

July 18, 2019 (Actual)

Study Completion Date

December 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The primary objective of this study is to determine the feasibility of TFRT planning and delivery for head and neck squamous cell carcinoma. Secondary objectives include estimating grade 3-5 acute toxicity (within 90 days) and describing patient-reported outcomes (PRO) of toxicity during and after TFRT. This study is planned as a single arm feasibility trial to demonstrate clinical delivery of TFRT plans. Five patients will be accrued as a single cohort. When using standard-of-care intensity modulated radiation therapy (IMRT), a single radiation plan is created and delivered on a daily basis Monday-Friday for a total of 7 weeks. In contrast, when using TFRT, up to 5 different plans are created and delivered each specific day of the week. Treatments will still occur on a daily basis Monday-Friday for 7 weeks. In each of these radiation plans used for TFRT, the radiation dose that will be delivered to the nearby healthy tissues will vary, allowing for increased time for normal tissue to recover from radiation-induced damage. Once weekly, a slightly higher radiation dose will be delivered to the "feathered" organ. On the remaining four days of the week, a slightly lower radiation dose will be delivered to the "feathered" organ. The radiation dose that will be delivered to the areas of cancer will not be changed. In this study, only the radiation dose delivered to the normal healthy tissues will be changed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

Keywords

Radiation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Temporally Feathered Radiation Therapy (TFRT)

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Temporally Feathered Radiation Therapy (TFRT)

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

15 days from start of treatment

Secondary Outcome Measure Information:

Title

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

Description

Number of participants who experienced grade 3-5 acute toxicities as defined by CTCAE version 4

Time Frame

Up to 90 days after treatment

Title

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

Description

Global health status/health-related quality of life measurements based on European Organization of Research and Treatment Of Cancer tool general (EORTC QLQ-H&N35). Scores range from 0-100.

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Xerostomia Questionnaire is a questionnaire used to describe mouth dryness and its effects on daily life. Scores range from 0-100. A high score represents a worse Xerostomia.

Time Frame

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

Title

Number of Participants Considered Compliant With Plan Delivery

Description

Time Frame

5 months from start of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nikhil Joshi, MD

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

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

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