Clinical trial NCT03768856: Temporally Feathered Radiation Therapy (TFRT) for Head and Neck Squamous Cell Carcinoma
Official title: Feasibility Study of Temporally Feathered Radiation Therapy (TFRT) for Head and Neck Squamous Cell Carcinoma: Means of Toxicity Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Radiation
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

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).

Primary outcomes:
measure: Feasibility of TFRT Planning and Delivery Defined by Number of Participants Starting Radiotherapy Within 15 Days of Simulation
timeFrame: 15 days from start of treatment
Secondary outcomes:
measure: Number of Participants Who Experienced Grade 3-5 Acute Toxicities Per CTCAE Version 4
timeFrame: Up to 90 days after treatment
measure: Participant-reported Outcomes (PRO) During TFRT Using EORTC QLQ-C30 Questionnaire
timeFrame: At weeks 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment
measure: Participant-reported Outcomes (PRO) During TFRT Using EORTC QLQ-H&N35 Questionnaire
timeFrame: At weeks 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment
measure: Participant-reported Outcomes (PRO) of Mouth Dryness After TFRT Using Xerostomia Questionnaire
timeFrame: At week 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment
measure: Number of Participants Considered Compliant With Plan Delivery
timeFrame: 5 months from start of treatment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Nikhil Joshi, MD
role: PRINCIPAL_INVESTIGATOR
References: