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

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ClinicalTrials.gov Identifier: NCT03768856
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Radiation: Temporally Feathered Radiation Therapy (TFRT) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility Study of Temporally Feathered Radiation Therapy (TFRT) for Head and Neck Squamous Cell Carcinoma: Means of Toxicity Reduction
Actual Study Start Date : December 7, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Temporally Feathered Radiation Therapy (TFRT)
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)
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 Measures :
  1. Feasibility of TFRT planning and delivery defined by number of participants starting radiotherapy within 15 days of simulation [ Time Frame: 15 days from start of treatment ]
    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 :
  1. Acute grade 3-5 toxicity as per CTCAE version 4 [ Time Frame: 90 days after treatment ]
    Number of Grade 3-5 acute toxicities as defined by CTCAE version 4

  2. Patient-reported outcomes (PRO) during TFRT using EORTC QLQ-C30 questionnaire [ Time Frame: At week 1 of treatment ]
    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.

  3. Patient-reported outcomes (PRO) during TFRT using EORTC QLQ-C30 questionnaire [ Time Frame: At week 4 of treatment ]
    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.

  4. Patient-reported outcomes (PRO) during TFRT using EORTC QLQ-C30 questionnaire [ Time Frame: At week 7 of treatment ]
    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.

  5. Patient-reported outcomes (PRO) after TFRT using EORTC QLQ-C30 questionnaire [ Time Frame: At 2 weeks post treatment ]
    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.

  6. Patient-reported outcomes (PRO) after TFRT using EORTC QLQ-C30 questionnaire [ Time Frame: At 4 weeks post treatment ]
    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.

  7. Patient-reported outcomes (PRO) after TFRT using EORTC QLQ-C30 questionnaire [ Time Frame: At 3 months post treatment ]
    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.

  8. Patient-reported outcomes (PRO) during TFRT using EORTC QLQ-H&N35 questionnaire [ Time Frame: At week 1 of treatment ]
    Health-related quality of life measurements and symptoms among head and neck cancer patients based on European Organization of Research and Treatment of Head and Neck cancer questionnaire (EORTC QLQ-C30). Scores range from 0-100.

  9. Patient-reported outcomes (PRO) during TFRT using EORTC QLQ-H&N35 questionnaire [ Time Frame: At week 4 of treatment ]
    Health-related quality of life measurements and symptoms among head and neck cancer patients based on European Organization of Research and Treatment of Head and Neck cancer questionnaire (EORTC QLQ-C30). Scores range from 0-100.

  10. Patient-reported outcomes (PRO) during TFRT using EORTC QLQ-H&N35 questionnaire [ Time Frame: At week 7 of treatment ]
    Health-related quality of life measurements and symptoms among head and neck cancer patients based on European Organization of Research and Treatment of Head and Neck cancer questionnaire (EORTC QLQ-C30). Scores range from 0-100.

  11. Patient-reported outcomes (PRO) after TFRT using EORTC QLQ-H&N35 questionnaire [ Time Frame: At 2 weeks post treatment ]
    Health-related quality of life measurements and symptoms among head and neck cancer patients based on European Organization of Research and Treatment of Head and Neck cancer questionnaire (EORTC QLQ-C30). Scores range from 0-100.

  12. Patient-reported outcomes (PRO) after TFRT using EORTC QLQ-H&N35 questionnaire [ Time Frame: At 4 weeks post treatment ]
    Health-related quality of life measurements and symptoms among head and neck cancer patients based on European Organization of Research and Treatment of Head and Neck cancer questionnaire (EORTC QLQ-C30). Scores range from 0-100.

  13. Patient-reported outcomes (PRO) after TFRT using EORTC QLQ-H&N35 questionnaire [ Time Frame: At 3 months post treatment ]
    Health-related quality of life measurements and symptoms among head and neck cancer patients based on European Organization of Research and Treatment of Head and Neck cancer questionnaire (EORTC QLQ-C30). Scores range from 0-100.

  14. Patient-reported outcomes (PRO) of mouth dryness during TFRT using Xerostomia Questionnaire [ Time Frame: At week 1 of treatment ]
    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.

  15. Patient-reported outcomes (PRO) of mouth dryness during TFRT using Xerostomia Questionnaire [ Time Frame: At week 4 of treatment ]
    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.

  16. Patient-reported outcomes (PRO) of mouth dryness during TFRT using Xerostomia Questionnaire [ Time Frame: At week 7 of treatment ]
    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.

  17. Patient-reported outcomes (PRO) of mouth dryness after TFRT using Xerostomia Questionnaire [ Time Frame: At 2 weeks post treatment ]
    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.

  18. Patient-reported outcomes (PRO) of mouth dryness after TFRT using Xerostomia Questionnaire [ Time Frame: At 4 weeks post treatment ]
    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.

  19. Patient-reported outcomes (PRO) of mouth dryness after TFRT using Xerostomia Questionnaire [ Time Frame: At 3 months post treatment ]
    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.

  20. Compliance with plan delivery [ Time Frame: 5 months from start of treatment ]
    Number of patients 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768856


Contacts
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Contact: Nikhil Joshi, MD 886-223-8100 CancerCenterResearch@ccf.org

Locations
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United States, Ohio
Cleveland Clinic, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Nikhil Joshi, MD    800-641-2422    cancer@case.edu   
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Nikhil Joshi, MD The Cleveland Clinic

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03768856     History of Changes
Other Study ID Numbers: CASE4318
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Case Comprehensive Cancer Center:
Radiation

Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site