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Whole Pelvis Proton Radiation for Gynecologic Cancer — GynWPProton  

Cervical Cancer Clinical Trial

Official title:
Phase II Study of Whole Pelvis Proton Radiotherapy for Postoperative Gynecologic Cancer

Clinical Trial Summary

This is a single institution, multi-center, Phase II, single-arm study, using Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) in the post-surgical, adjuvant setting for definitive treatment of gynecologic cancers. The purpose of this study is to estimate rate of acute clinician-reported gastrointestinal (GI) toxicity using WP PBS PRT in the definitive treatment of gynecologic cancers in the post-surgical, adjuvant setting.

Clinical Trial Description

Study Population: This is a single institution, multi-site study, and thus will include patients from geographic locations with Penn proton centers in the Philadelphia, Lancaster and South New Jersey area. Description of Sites/Facilities: The study will be conducted at the University of Pennsylvania Department of Radiation Oncology and associated Clinical facilities. Enrolling Sites: Enrolling sites are within the Penn institution and have proton capabilities. They include the following facilities: 1. Penn Medicine Abramson Center in Philadelphia, PA 2. Penn Medicine Lancaster General Health in Lancaster, PA 3. Penn Medicine Virtua Voorhees in South New Jersey Description of Study Intervention: Patients will be treated with PBS PRT with doses of 45 or 50.4Gy relative biological effectiveness (RBE) in 1.8Gy daily fractions. Study Duration: The duration of the study will be 6 months after the last patient was treated. The recruitment period is planned over 24 months. Thus, estimated time from when study opens to completion of data analysis is 36 months. Participant Duration: 6 months from end of treatment, which including treatment time is approximately 7.5 months ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05758688
Study type Interventional
Source Abramson Cancer Center at Penn Medicine
Contact Neil K Taunk, MD, MSCTS
Phone 267-593-9059
Email taunk@pennmedicine.upenn.edu
Status Recruiting
Phase N/A
Start date November 6, 2023
Completion date March 2026
View Details
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