PROton Therapy for Post Surgical Treatment of GYNecologic Cancer (PROPS GYN)

June 9, 2026 updated by: Abramson Cancer Center at Penn Medicine

Adjuvant Proton Whole Pelvis Radiation Therapy for Treatment of Post-Surgical Gynecologic Cancers

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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. The study will be conducted at the University of Pennsylvania Department of Radiation Oncology and associated Clinical facilities.

The study intervention is Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) as part of the definitive treatment of gynecologic cancers in the post-hysterectomy, adjuvant setting. Patients will be treated with doses of 45 or 50.4 Gy in 1.8 Gy daily fractions.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • Voorhees Township, New Jersey, United States, 08043
        • Recruiting
        • Virtua Health
        • Contact:
        • Contact:
        • Principal Investigator:
          • Graeme Williams, MD, MBA
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17601
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Contact:
          • MD
        • Contact:
        • Principal Investigator:
          • Neil K Taunk, MD, MSCTS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed cervical or endometrial cancer
  • Indication for adjuvant whole pelvic radiation therapy, with or without systemic therapy
  • Age of 18 years or older
  • Written informed consent
  • ECOG of 0-2 within 3 months of enrolling

Exclusion Criteria:

  • Prior course of pelvic radiation
  • Metastatic disease outside of the pelvis
  • Active inflammatory bowel disease
  • Incapacity to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adjuvant Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT)
The study intervention is Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) as part of the definitive treatment of gynecologic cancers in the post-hysterectomy, adjuvant setting. Patients will be treated with doses of 45 or 50.4 Gy in 1.8 Gy daily fractions. The volume treated will include the whole pelvis according to Radiation Therapy Oncology Group post-hysterectomy pelvis guidelines.
Radiation: Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT)
The study intervention is Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) as part of the definitive treatment of gynecologic cancers in the post-hysterectomy, adjuvant setting. Patients will be treated with doses of 45 or 50.4 Gy in 1.8 Gy daily fractions. The volume treated will include the whole pelvis according to Radiation Therapy Oncology Group post-hysterectomy pelvis guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute clinician-reported gastrointestinal (GI) toxicity.
Time Frame: Up to 6 months after end of treatment at follow up visits
Determine the rate of acute clinician-reported gastrointestinal (GI), with the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria. Acute GI grade 2 or higher toxicity is the primary powering endpoint.
Up to 6 months after end of treatment at follow up visits

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute clinician-reported genitourinary (GU) toxicity.
Time Frame: Up to 6 months after end of treatment at follow up visits
Determine the rate of the acute clinician-reported genitourinary (GU) toxicity, with the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria.
Up to 6 months after end of treatment at follow up visits
Acute patient-reported gastrointestinal (GI) and genitourinary (GU) toxicity and quality of life.
Time Frame: Up to 6 months after end of treatment at follow up visits
Determine the rate of acute patient-reported gastrointestinal (GI) and genitourinary (GU) toxicity and quality of life using the EPIC urinary and bowel score (expanded prostate cancer index composite) and FACT-Cx.
Up to 6 months after end of treatment at follow up visits
Loco-regional recurrence free survival, disease free survival, and overall survival.
Time Frame: Up to 2 years
Determine loco-regional recurrence free survival, disease free survival, and overall survival.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Investigators

  • Principal Investigator: Neil K Taunk, MD, MSCTS, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 24, 2023

First Submitted That Met QC Criteria

February 24, 2023

First Posted (Actual)

March 7, 2023

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 27822
  • 852760 (Other Identifier: University of Pennsylvania)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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