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Testing the Safety of Giving a Standard Dose of Radiation Over a Shorter Period of Time for Patients Who Had Surgery for Intermediate-Risk Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:
Phase I Safety Assessment of Hypofractionated Postoperative Radiotherapy (H-PORT) for Intermediate-Risk Head and Neck Cancer

Clinical Trial Summary

This phase I trial is looking to determine if hypofractionated radiation therapy can be given safely after surgery for intermediate-risk head and neck cancer.

Clinical Trial Description

PRIMARY OBJECTIVE: I. 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: I. To assess H-PORT treatment-related and unrelated adverse events during treatment and within one year after treatment completion. II. To assess H-PORT tolerability and compliance, as measured by treatment interruptions and discontinuations, and to assess the reasons for those modifications. ARM I: Patients undergo surgery per standard of care followed by hypofractionated radiotherapy. Patients receive 50 Gy over 4 weeks (i.e., 2.5 Gy per day x 20 fractions). Radiation therapy should start after there is adequate healing and no evidence of gross residual/recurrent cancer. Patients are followed up at 1 month, 3 months, 6 months and 12 months post H-PORT therapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05540899
Study type Interventional
Source American College of Radiology
Contact Etta Pisano, MD
Phone 215-574-3150
Email episano@acr.org
Status Recruiting
Phase Phase 1
Start date November 8, 2023
Completion date November 2028
View Details
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