Head and Neck CancerNCT03768856
Temporally Feathered Radiation Therapy (TFRT) for Head and Neck Squamous Cell Carcinoma
A study testing Temporally Feathered Radiation Therapy (TFRT) in people with Head and Neck Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Temporally Feathered Radiation Therapy (TFRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2018to 3 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Feasibility Study of Temporally Feathered Radiation Therapy (TFRT) for Head and Neck Squamous Cell Carcinoma: Means of Toxicity Reduction
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- Temporally Feathered Radiation Therapy (TFRT)
- Keywords
- Radiation
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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". Receives: Radiation: Temporally Feathered Radiation Therapy (TFRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 days from start of treatment
Secondary outcomes (5)
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
Measured: Up to 90 days after treatment
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 months from start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start7 Dec 2018
- Primary completion18 Jul 2019
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikhil Joshi, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768856
- Sponsor's protocol ID
- CASE4318
- Status last verified
- Jun 2022
- First submitted
- 13 Nov 2018
- Last updated
- 27 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Temporally Feathered Radiation Therapy (TFRT) for Head and Neck Squamous Cell Carcinoma: Means of Toxicity Reduction
- ClinicalTrials.gov ID
- NCT03768856
- Acronym / sponsor ID
- CASE4318
- Conditions
- Head and Neck Cancer
- Keywords
- Radiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 18 Jul 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Posted 27 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temporally Feathered Radiation Therapy (TFRT) | Experimental | Radiation: 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". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | Temporally Feathered Radiation Therapy (TFRT) |
Primary outcome
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.
5 secondary outcomes
Number of Participants Who Experienced Grade 3-5 Acute Toxicities Per CTCAE Version 4
Time frame: Up to 90 days after treatment
Participant-reported Outcomes (PRO) During TFRT Using EORTC QLQ-C30 Questionnaire
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 5 months from start of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikhil Joshi, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporally Feathered Radiation Therapy (TFRT) in people with Head and Neck Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.