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RecruitingPhase 1NCT03750513

LET Optimized IMPT in Treating Pediatric Patients With Ependymoma

Pilot Trial of LET Optimized IMPT for Pediatric Patients With Ependymoma

Sponsor

M.D. Anderson Cancer Center

Enrollment

48 participants

Start Date

Apr 1, 2019

Study Type

INTERVENTIONAL

Conditions

EpendymomaAnaplastic Ependymoma

Summary

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.

Eligibility

Max Age: 22 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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

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Interventions

RADIATIONLinear Energy Transfer-Optimized Intensity Modulated Proton Therapy

Given LET optimized IMPT

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

Locations(2)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

M D Anderson Cancer Center

Houston, Texas, United States

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NCT03750513

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