HYPORT: A Phase I/II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck Cancer
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- STATUS
- Recruiting
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- End date
- Aug 5, 2027
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- participants needed
- 98
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- sponsor
- University of Texas Southwestern Medical Center
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.
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 (3-4 weeks depending on Phase 1 results) to establish non-inferiority of hypofractionated radiation therapy.
Details
| Condition | Head and Neck Squamous Cell Carcinoma |
|---|---|
| Age | 18-100 years |
| Treatment | Intensity-modulated radiation therapy (IMRT) |
| Clinical Study Identifier | NCT04403620 |
| Sponsor | University of Texas Southwestern Medical Center |
| Last Modified on | 19 February 2024 |
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