PROton Therapy for Post Surgical Treatment of GYNecologic Cancer

Phase 2

Recruiting

• Conditions: Endometrial Cancer; Cervical Cancer; Uterine Cancer
• Interventions: Radiation: Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT)

• Registration Number: NCT05758688
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief 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.

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 Timeline

• Study First Submitted: 2023-01-24
• Study First Submitted QC: 2023-02-24
• Study First Posted: 2023-03-07
• Study Start: 2023-11-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-10
• Primary Completion: 2026-05
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adjuvant Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT)	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.

Primary Outcome Measures

Name	Time	Method
Acute clinician-reported gastrointestinal (GI) toxicity.	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 Outcome Measures

Name	Time	Method
Acute clinician-reported genitourinary (GU) toxicity.	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.
Loco-regional recurrence free survival, disease free survival, and overall survival.	Up to 2 years	Determine loco-regional recurrence free survival, disease free survival, and overall survival.
Acute patient-reported gastrointestinal (GI) and genitourinary (GU) toxicity and quality of life.	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.

Trial Locations

Locations (3)

Virtua Health; 🇺🇸 Voorhees, New Jersey, United States

Lancaster General Health - Ann B. Barshinger Cancer Institute; 🇺🇸 Lancaster, Pennsylvania, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States