HYPORT: A Phase I/II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck… (NCT04403620) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
HYPORT: A Phase I/II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck Cancer
United States59 participantsStarted 2020-07-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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.
✓. 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
✕. 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
What they're measuring
1
Phase 1: Maximally tolerated dose of hypofractionated radiation therapy
Timeframe: 3 months
2
Phase 2: Swallowing-related patient-reported quality of life
Timeframe: 12 months
Trial details
NCT IDNCT04403620
SponsorUniversity of Texas Southwestern Medical Center
✕. 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.