Recruiting

Phase 2

WP PBS PRTPROton Therapy for Post Surgical Treatment of GYNecologic Cancer

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT05758688

Conditions

Cervical Cancer

Uterine Cancer

Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Cervical Cancer

Uterine Cancer

Endometrial Cancer

Study ID

NCT05758688

Start date

Nov 6, 2023

Status verified date

Sep, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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

Primary outcome measure

Acute clinician-reported gastrointestinal (GI) toxicity. [ Time Frame: Up to 6 months after end of treatment at follow up visits ]

Central Contacts and Locations

Central contacts

Project Manager

215-662-3790 RadOncCRU@PennMedicine.upenn.edu

Locations

Virtua Health

Recruiting

Voorhees Township, New Jersey, United States, 08043

Contacts

Kristina Montagno, RN, BSN

856-206-4728 kmontag1@virtua.org

Barbara Dillon, MSN, RN

856-247-7395 bdillon@virtua.org

Principal Investigator:

Catherine Kim, MD

Lancaster General Health - Ann B. Barshinger Cancer Institute

Recruiting

Lancaster, Pennsylvania, United States, 17601

Contacts

Susan Tollett, BSN, RN, OCN

717-544-0511 susan.tollett@pennmedicine.upenn.edu

Alyson Eckert, BSN, RN, OCN

717-544-0511 alyson.eckert@pennmedicine.upenn.edu

Principal Investigator:

Pamela Boimel, MD, PhD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Project Manager

RadOncCRU@PennMedicine.upenn.edu

Principal Investigator:

Neil K Taunk, MD, MSCTS

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-09-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.