HYPORT: A Phase I/II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck Squamous Cell Carcinoma

University of Texas Southwestern Medical Center1 site in 1 country59 target enrollmentJuly 28, 2020

ConditionsSquamous Cell Carcinoma of Head and Neck

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Squamous Cell Carcinoma of Head and Neck
Sponsor: University of Texas Southwestern Medical Center
Enrollment: 59
Locations: 1
Primary Endpoint: Phase 1: Maximally tolerated dose of hypofractionated radiation therapy
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

There is a strong radiobiological and economic rationale for hypofractionated radiation therapy in head and neck cancer. Phase 1 of the trial aims to assess the acute toxicity and tolerability of hypofractionated radiation therapy in the post-operative setting, and to determine the dose/fractionation for Phase 2. Phase 2 aims to establish non-inferiority of swallowing-related quality of life and to assess the toxicity and efficacy of hypofractionated radiation therapy compared to conventionally fractionated radiation therapy in the post-operative setting.

Detailed Description

The trial will assess the effects of aggressive hypofractionated radiation therapy in patients with oral cavity, oropharynx, hypopharynx, or larynx cancer after surgical resection with pathology showing intermediate risk factors requiring post-operative radiation therapy without concurrent chemotherapy. During Phase 1, the maximum tolerated dose/fractionation and tolerability will be determined. During Phase 2, patients will be randomized between conventionally fractionated radiation therapy (6 weeks) vs. hypofractionated radiation therapy (3 weeks) to establish non-inferiority of hypofractionated radiation therapy.

Registry

clinicaltrials.gov

Start Date

July 28, 2020

End Date

August 2027

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

University of Texas Southwestern Medical Center

Responsible Party

Principal Investigator

Dominic Moon

Assistant Professor

University of Texas Southwestern Medical Center

Eligibility Criteria

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:

Exclusion Criteria

•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.