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Protocol Summary


Protocol No.
PSCI-22-140
Prinicipal Investigator
Machtay, Mitchell
Phase
Phase I
Age Group
Adult
Scope
National
Secondary Protocol No.
ACR 3518
Title
ACR 3518: Phase I Safety Assessment of Hypofractionated Postoperative Radiotherapy (H-PORT) for Intermediate-Risk Head and Neck Cancer
Objective
Primary Objective: To determine if a hypofractionated postoperative radiotherapy (H-PORT) schedule for patients with intermediate-risk head and neck cancer (squamous cell carcinoma of the oral cavity, oropharynx, or larynx) who have undergone surgery is safe and feasible for further evaluation in a phase II clinical trial.

Secondary Objectives: To assess H-PORT treatment-related and unrelated adverse events during treatment and within one year after treatment completion. To assess H-PORT tolerability and compliance, as measured by treatment interruptions and discontinuations, and to assess the reasons for those modifications.
Applicable Disease Sites
Head and Neck
Status
Open
Participating Institutions
Hershey Medical Center