Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05758688

PROton Therapy for Post Surgical Treatment of GYNecologic Cancer

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cervical Cancer Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cancer Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Virtua Health, Voorhees Township, New Jersey, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT)

Radiation

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Project Manager

CONTACT

[email protected]

215-662-3790

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

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

Acronym: PROPS GYN

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2023
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.