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RecruitingInterventionalPhase 2

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

NCT ID: NCT05758688Sponsor: Abramson Cancer Center at Penn MedicineLast updated: 2026-06-10

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.

Arms & interventions

  • RadiationWhole 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.

Outcome measures

Primary

  • Acute clinician-reported gastrointestinal (GI) toxicity.

    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.

    Time frame: Up to 6 months after end of treatment at follow up visits

Secondary

  • Acute clinician-reported genitourinary (GU) toxicity.

    Time frame: Up to 6 months after end of treatment at follow up visits

  • 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

  • Loco-regional recurrence free survival, disease free survival, and overall survival.

    Time frame: Up to 2 years

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
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 locations (3)

Virtua Health

Voorhees Township, New Jersey, 08043

Recruiting
Kristina Montagno, RN, BSN · Contact
Barbara Dillon, MSN, RN · Contact
Graeme Williams, MD, MBA · Principal Investigator

Lancaster General Health - Ann B. Barshinger Cancer Institute

Lancaster, Pennsylvania, 17601

Recruiting
Susan Tollett, BSN, RN, OCN · Contact
Alyson Eckert, BSN, RN, OCN · Contact
Pamela Boimel, MD, PhD · Principal Investigator

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Recruiting
Project Manager · Contact
MD · Contact
Neil K Taunk, MD, MSCTS · Principal Investigator