PROton Therapy for Post Surgical Treatment of GYNecologic Cancer

Sponsor: Abramson Cancer Center at Penn Medicine

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05758688

Patient View

This Phase II, single-arm study at the University of Pennsylvania evaluates Whole Pelvis Pencil Beam Scanning Proton Radiation for post-surgical gynecologic cancer treatment. Eligible participants are adults with confirmed cervical or endometrial cancer needing adjuvant radiation. The intervention involves 45 or 50.4 Gy doses in 1.8 Gy fractions, targeting the whole pelvis.

Patient Parameters

Program Overview

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.

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.

Eligibility Criteria

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

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