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PROton Therapy for Post Surgical Treatment of GYNecologic Cancer

RECRUITINGPhase 2Sponsored by Abramson Cancer Center at Penn Medicine
Actively Recruiting
PhasePhase 2
SponsorAbramson Cancer Center at Penn Medicine
Started2023-11-06
Est. completion2026-05
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations3 sites

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.

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers 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

Conditions4

CancerCervical CancerEndometrial CancerUterine Cancer

Locations3 sites

New Jersey

1 site
Virtua Health
Voorhees Township, New Jersey, 08043
Kristina Montagno, RN, BSN856-206-4728kmontag1@virtua.org

Pennsylvania

2 sites
Lancaster General Health - Ann B. Barshinger Cancer Institute
Lancaster, Pennsylvania, 17601
Susan Tollett, BSN, RN, OCN717-544-0511susan.tollett@pennmedicine.upenn.edu
University of Pennsylvania
Philadelphia, Pennsylvania, 19104

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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