Head and Neck Cancer Clinical Trial
Official title:
Feasibility Study of Temporally Feathered Radiation Therapy (TFRT) for Head and Neck Squamous Cell Carcinoma: Means of Toxicity Reduction
Verified date | June 2022 |
Source | Case Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | December 3, 2019 |
Est. primary completion date | July 18, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic, Case Comprehensive Cancer Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 15 days from start of treatment | |
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 | Up to 90 days after treatment | |
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. | At weeks 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment | |
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. | At weeks 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment | |
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. | At week 1, 4, and 7 of treatment and at 2 weeks, 4 weeks, and 3 months post-treatment | |
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. | 5 months from start of treatment |
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