Trial Outcomes & Findings for Temporally Feathered Radiation Therapy (TFRT) for Head and Neck Squamous Cell Carcinoma (NCT NCT03768856)
NCT ID: NCT03768856
Last Updated: 2022-06-27
Results Overview
Number of participants starting radiotherapy within 15 days of simulation. The TFRT technique will be deemed feasible if 3/5 participants meet this criteria.
COMPLETED
NA
5 participants
15 days from start of treatment
2022-06-27
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Temporally Feathered Radiation Therapy (TFRT) for Head and Neck Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Temporally Feathered Radiation Therapy (TFRT)
n=5 Participants
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.
|
|---|---|
|
Age, Customized
50-59 years
|
2 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 days from start of treatmentPopulation: Participants enrolled in study
Number of participants starting radiotherapy within 15 days of simulation. The TFRT technique will be deemed feasible if 3/5 participants meet this criteria.
Outcome measures
| Measure |
Temporally Feathered Radiation Therapy (TFRT)
n=5 Participants
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.
|
|---|---|
|
Feasibility of TFRT Planning and Delivery Defined by Number of Participants Starting Radiotherapy Within 15 Days of Simulation
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 90 days after treatmentPopulation: Participants enrolled in study
Number of participants who experienced grade 3-5 acute toxicities as defined by CTCAE version 4
Outcome measures
| Measure |
Temporally Feathered Radiation Therapy (TFRT)
n=5 Participants
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.
|
|---|---|
|
Number of Participants Who Experienced Grade 3-5 Acute Toxicities Per CTCAE Version 4
|
1 Participants
|
SECONDARY outcome
Timeframe: At weeks 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatmentPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At weeks 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatmentPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At week 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatmentPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 months from start of treatmentPopulation: Participants enrolled in study
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.
Outcome measures
| Measure |
Temporally Feathered Radiation Therapy (TFRT)
n=5 Participants
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.
|
|---|---|
|
Number of Participants Considered Compliant With Plan Delivery
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4 Participants
|
Adverse Events
Temporally Feathered Radiation Therapy (TFRT)
Serious adverse events
| Measure |
Temporally Feathered Radiation Therapy (TFRT)
n=5 participants at risk
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.
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|---|---|
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Endocrine disorders
Acute kidney injury
|
20.0%
1/5 • Number of events 2 • Up to 3 mos post post-treatment
|
Other adverse events
Adverse event data not reported
Additional Information
Dr Shlomo Koyfman
Cleveland Clinic, Case Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place