N/A
N=5
Temporally Feathered Radiation Therapy (TFRT) for Head and Neck Squamous Cell Carcinoma
Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03768856 ↗Enrolled (actual)
5
Serious AEs
20.0%
Results posted
Jul 2020
Primary outcome: Primary: Feasibility of TFRT Planning and Delivery Defined by Number of Participants Starting Radiotherapy Within 15 Days of Simulation — 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Temporally Feathered Radiation Therapy (TFRT) (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Comprehensive Cancer Center
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of TFRT Planning and Delivery Defined by Number of Participants Starting Radiotherapy Within 15 Days of Simulation |
4 | — |
| SECONDARY Number of Participants Who Experienced Grade 3-5 Acute Toxicities Per CTCAE Version 4 |
1 | — |
| SECONDARY Participant-reported Outcomes (PRO) During TFRT Using EORTC QLQ-C30 Questionnaire |
— | — |
| SECONDARY Participant-reported Outcomes (PRO) During TFRT Using EORTC QLQ-H&N35 Questionnaire |
— | — |
| SECONDARY Participant-reported Outcomes (PRO) of Mouth Dryness After TFRT Using Xerostomia Questionnaire |
— | — |
| SECONDARY Number of Participants Considered Compliant With Plan Delivery |
4 | — |
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.
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).
Data sourced from ClinicalTrials.gov (NCT03768856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.