Pilot Trial of LET Optimized IMPT for Pediatric Patients With Ependymoma

Trial ID: NCT03750513

Interventional - Phase 1 - Recruiting

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

Interventions

• Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy
• Quality-of-Life Assessment
• Questionnaire Administration

Eligibility

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

Sponsor

M.D. Anderson Cancer Center, National Cancer Institute (NCI)

Source: ClinicalTrials.gov

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