RECRUITING
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PROton Therapy for Post Surgical Treatment of GYNecologic Cancer
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 Start (Actual) 6 November 2023
🗓️ Primary Completion (Estimated) May 2026
✅ Study Completion (Estimated) November 2026
👥 Enrollment (Estimated) 25
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Philadelphia, Pennsylvania, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 January 2023
  • First Submitted that Met QC Criteria 24 February 2023
  • First Posted 7 March 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 3 July 2024
  • Last Update Posted 5 July 2024
  • Last Verified July 2024
I'm interested ...!!