NCT05538533

Hypofractionated Preoperative Radiation for Head and Neck Cancers (HyPR-HN)

A Phase I Study of Hypofractionated Preoperative Radiation for Head and Neck Cancers (HyPR-HN)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1 study to determine the safety of a condensed preoperative radiation regimen (10, 7, or 5 fractions) for the management of head and neck squamous cell carcinoma.

Detailed description

All subjects in this study will receive pre-operative hypofractionated radiation therapy, which will be subject to fractionation reduction, that being 10 fractions, 7 fractions, or 5 fractions, as compared to 30 fractions of conventional radiation therapy. All patients will subsequently undergo surgery for resection of remaining disease at the primary site and at-risk nodal basins 6-8 weeks after completion of radiation. The subjects will receive smaller number of fractions (total visits) but with a higher dose of radiation with each Dose Level. Participants will receive a total radiation dose of 46 Gy in 10 fractions (Dose Level 1), 40 Gy in 7 fractions (Dose Level 2), or 35 Gy in 5 fractions (Dose Level 3), depending on the assigned experimental total fractions. Radiation will be delivered using intensity modulated radiation therapy (IMRT) with a daily cone-beam CT for five days a week, for less than two weeks depending on the assigned dose level at the time of enrollment. Due to the novelty of translational data and non-dependency on the primary endpoint, presentation and publication in a scientific journal of the translational endpoints may precede publication of the primary endpoint.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
RADIATION	46 Gy Radiation Therapy	Dose per fraction of 4.6.
RADIATION	40 Gy Radiation Therapy	Dose per fraction 5.7.
RADIATION	35 Gy Radiation Therapy	Dose per fraction 7.0.

Timeline

• Start date: 2023-01-06
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2022-09-14
• Last updated: 2026-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study