HYPORT: A Phase I/II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck Cancer (NCT04403620)
HYPORT: A Phase I/II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck Squamous Cell Carcinoma
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (15 items) and avoid the listed exclusions (12 items).
Location: University of Texas Southwestern Medical Center — Dallas, Texas
Age range: 18 Years
🧪 Interventions in This Study
- Intensity-modulated Radiation Therapy (IMRT) (RADIATION)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of Texas Southwestern Medical Center — Dallas, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Squamous Cell Carcinoma of Head and Neck
- A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer — La Jolla, California
- Pembrolizumab Plus Olaparib in LA-HNSCC — Indianapolis, Indiana
- TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC — Tampa, Florida
- Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas — Philadelphia, Pennsylvania
- 5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC — New Haven, Connecticut
Explore by condition: All Squamous Cell Carcinoma of Head and Neck clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.