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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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". |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 90 days after treatment |
| Participant-reported Outcomes (PRO) During TFRT Using EORTC QLQ-C30 Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nikhil Joshi, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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". 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants enrolled in study
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| ID | Title | Description |
|---|---|---|
| BG000 | 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". 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants enrolled in study | Posted | Count of Participants | Participants | 15 days from start of treatment |
|
Up to 3 mos post post-treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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". 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Endocrine disorders | CTCAE v5.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Shlomo Koyfman | Cleveland Clinic, Case Comprehensive Cancer Center | 1-800-223-2273 | TaussigResearch@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2020 | Jun 1, 2022 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 26, 2019 | Jul 13, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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. |
| 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 | 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. | 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 | 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. | 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 | 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. | 5 months from start of treatment |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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 | Participants enrolled in study | Posted | Count of Participants | Participants | Up to 90 days after treatment |
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| Secondary | 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. | No participant were analyzed for quality of life questionnaires as there was an error in obtaining this data. A trial deviation was filed for this error. | Posted | At weeks 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment |
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| Secondary | 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. | No participants were analyzed for quality of life questionnaires as there was an error in obtaining this data. A trial deviation was filed for this error. | Posted | At weeks 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment |
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| Secondary | 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. | No participants were analyzed for quality of life questionnaires as there was an error in obtaining this data. A trial deviation was filed for this error. | Posted | At week 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment |
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| Secondary | 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. | Participants enrolled in study | Posted | Count of Participants | Participants | 5 months from start of treatment |
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