PROton Therapy for Post Surgical Treatment of GYNecologic Cancer

NCT ID: NCT05758688

Last Updated: 2025-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-06

Study Completion Date

2026-11-30

Brief Summary

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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

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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.

Conditions

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Cervical Cancer Uterine Cancer Endometrial Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil K Taunk, MD, MSCTS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Virtua Health

Voorhees Township, New Jersey, United States

Site Status RECRUITING

Lancaster General Health - Ann B. Barshinger Cancer Institute

Lancaster, Pennsylvania, United States

Site Status RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Project Manager

Role: CONTACT

215-662-3790

Facility Contacts

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Kristina Montagno, RN, BSN

Role: primary

856-206-4728

Barbara Dillon, MSN, RN

Role: backup

856-247-7395 ext. 77395

Susan Tollett, BSN, RN, OCN

Role: primary

717-544-0511

Alyson Eckert, BSN, RN, OCN

Role: backup

717-544-0511

Project Manager

Role: primary

MD

Role: backup

Other Identifiers

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852760

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 27822

Identifier Type: -

Identifier Source: org_study_id

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