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LET Optimized IMPT in Treating Pediatric Patients With Ependymoma
This phase I trial studies the side effects of linear energy transfer (LET) optimized image modulated proton therapy (IMPT) in treating pediatric patients with ependymoma. Radiation therapy such as LET optimized IMPT, uses proton beams to kill tumor cells and shrink tumors without damaging surrounding normal tissues.
Conditions:
🦠 Anaplastic Ependymoma 🦠 Ependymoma
🗓️ Study Start (Actual) 1 April 2019
🗓️ Primary Completion (Estimated) 31 December 2027
✅ Study Completion (Estimated) 31 December 2027
👥 Enrollment (Estimated) 48
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Boston, Massachusetts, United States
📍 Houston, Texas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Previous pathologic confirmation of ependymoma, World Health Organization (WHO) grade II or III
    • * Disease must be confined to the brain (no evidence of spread on MR imaging of the spine or on staging lumbar puncture)
    • * Patient may not receive chemotherapy concurrent with radiation
    • * Signed informed consent by patient and/or parents or legal guardian
    • * Lansky performance status score of 50 -100

    Exclusion Criteria:

    • * Patients with previous radiation therapy to the brain
    • * Ependymoma of the spine
    • * Disseminated ependymoma requiring craniospinal radiation therapy
    • * Pregnancy
    • * Inability to undergo MR imaging
    • * Inability to receive gadolinium-based contrast agent
Ages Eligible for Study: N/A to 22 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
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 15 November 2018
  • First Submitted that Met QC Criteria 20 November 2018
  • First Posted 23 November 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 7 May 2024
  • Last Update Posted 8 May 2024
  • Last Verified May 2024
I'm interested ...!!