- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04403620
HYPORT: A Phase I/II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck Cancer
HYPORT: A Phase I/II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck Squamous Cell Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Kajal Desai, MS
- Email: kajal.desai@utsouthwestern.edu
Study Contact Backup
- Name: Sarah Neufeld, MS
- Phone Number: 214-645-8525
- Email: sarah.hardee@utsouthwestern.edu
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75390
- Recruiting
- University of Texas Southwestern Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Inclusion criteria will be the same for Phase I and Phase II.
Pathologically proven diagnosis of stage I-IVB squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx status post gross total resection with pathology showing one or more of the following intermediate risk factors:
- T3/4 disease (AJCC 8th edition), positive lymph node(s), close margin(s), perineural invasion, and/or lymphovascular invasion
Close margin(s) defined as either:
- Final patient margin of <5 mm without disease on ink OR
- Initial positive margin in the specimen regardless of the final patient margin (e.g. if resection margin on the initial specimen is positive, final patient margin after subsequent resections can be ≥5 mm and still be considered close margin)
- Age ≥18 years
- ECOG performance status 0-2
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
Medically acceptable birth control (contraceptives) includes:
- approved hormonal contraceptives (such as birth control pills, patch or ring; Depo-Provera, Implanon), or
- barrier methods (such as condom or diaphragm) used with a spermicide
Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Negative serum or urine pregnancy test within 2 weeks before registration for women of childbearing potential.
- Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
Phase I:
- Distant metastasis
- Stage I and II glottic squamous cell carcinoma
- High risk factors following surgical resection requiring concurrent chemotherapy: final positive margin(s) and/or extranodal extension
- Feeding tube dependence at baseline assessment.
- Synchronous non-skin cancer primaries outside of the oropharynx, oral cavity, larynx, and hypopharynx except for low- and intermediate-risk prostate cancer and synchronous well-differentiated thyroid cancer. For prostate cancer, patient should not be receiving active treatment. For thyroid cancer, thyroid surgery may occur before or after treatment, provided all other eligibility criteria are met.
- Prior invasive malignancy with an expected disease-free interval of less than 3 years
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields
- Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.
- Uncontrolled intercurrent 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, in the opinion of the investigator, would limit compliance with study requirements
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- History of severe immunosuppression, including HIV, and organ or autologous or allogeneic stem cell transplant
Phase II:
The exclusion criteria will be the same as Phase I except for feeding tube dependence. Patients who are feeding tube dependent are excluded from Phase I to accurately assess treatment associated toxicity affecting swallowing and oral intake. During Phase II, patients who are feeding tube dependent will be eligible to enroll and stratified at randomization.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Conventionally fractionated radiotherapy
60 Gy in 30 fractions, 5 fractions/week
|
Patients will receive adjuvant radiation therapy using intensity-modulated radiation therapy (IMRT) within 8 weeks of surgical resection
|
Experimental: Hypofractionated radiotherapy
Dose and fractionation determined by Phase I: Level 1: 44.4 Gy in 12 fractions, 4 fractions/week Level 0: 46.5 Gy in 15 fractions, 5 fractions/week Level -1: 52 Gy in 20 fractions, 5 fractions/week Level -2: 50 Gy in 20 fractions, 5 fractions/week |
Patients will receive adjuvant radiation therapy using intensity-modulated radiation therapy (IMRT) within 8 weeks of surgical resection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase 1: Maximally tolerated dose of hypofractionated radiation therapy
Time Frame: 3 months
|
Dose and fractionation to be used for Phase 2
|
3 months
|
Phase 2: Swallowing-related patient-reported quality of life
Time Frame: 12 months
|
MD Anderson Dysphagia Inventory (MDADI) composite score: 20-100, higher scores mean better quality of life
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinician-reported acute toxicities
Time Frame: 1-3 months
|
CTCAE v5.0
|
1-3 months
|
Clinician-reported late toxicities
Time Frame: 6-24 months
|
CTCAE v5.0
|
6-24 months
|
Locoregional control
Time Frame: 12-24 months
|
12-24 months
|
|
Progression free survival
Time Frame: 12-24 months
|
12-24 months
|
|
Swallowing-related patient-reported quality of life
Time Frame: 1-24 months
|
MD Anderson Dysphagia Inventory (MDADI): 20-100, higher scores mean better quality of life
|
1-24 months
|
Head and neck patient-reported quality of life
Time Frame: 1-24 months
|
University of Washington QOL questionnaire (UW-QOL): 0-100, higher scores mean better quality of life
|
1-24 months
|
Xerostomia-related patient-reported quality of life
Time Frame: 1-24 months
|
University of Michigan Xerostomia questionnaire (XQ): 0-100, higher scores mean worse quality of life
|
1-24 months
|
General patient-reported quality of life
Time Frame: 1-24 months
|
EuroQol-5 dimensions (EQ-5D-5L): 1-5, higher scores mean worse quality of life
|
1-24 months
|
Feeding tube dependence
Time Frame: 1-24 months
|
Feeding tube dependence defined as daily use of the feeding tube with ≥2 nutritional supplements (e.g.
Ensure, Boost, etc.) per day at the time of enrollment on trial
|
1-24 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dominic Moon, MD, UT Southwestern Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU 2020-0522
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Squamous Cell Carcinoma of Head and Neck
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Washington University School of MedicineMerck Sharp & Dohme LLCActive, not recruitingHead and Neck Cancer | Squamous Cell Carcinoma of the Head and Neck | Cancer of Head and Neck | Carcinoma, Squamous Cell of Head and Neck | Neoplasms, Head and Neck | Squamous Cell Carcinoma, Head and NeckUnited States
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Arnaud Bewley, MDNational Cancer Institute (NCI); Genentech, Inc.TerminatedStage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 | Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck | Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and NeckUnited States
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