Status:
RECRUITING
LET Optimized IMPT in Treating Pediatric Patients With Ependymoma
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anaplastic Ependymoma
Ependymoma
Eligibility:
All Genders
Up to 22 years
Phase:
PHASE1
Brief 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 LE...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the safety of linear energy transfer (LET) optimized image modulated proton therapy (IMPT) (bio-IMPT) for pediatric patients with ependymoma. SECONDARY OBJECTIVES:...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03750513
Start Date
April 1 2019
End Date
December 31 2027
Last Update
November 13 2025
Active Locations (2)
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1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
2
M D Anderson Cancer Center
Houston, Texas, United States, 77030