Recruiting
Phase 1

LET Optimized IMPT

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT03750513

Conditions

Anaplastic Ependymoma

Ependymoma

Eligibility Criteria

Sex: All

Age: 0 - 22

Healthy Volunteers: Not accepted

Interventions

Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy

Quality-of-Life Assessment

Questionnaire Administration

Study Details

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 LET optimized IMPT, uses proton beams to kill tumor cells and shrink tumors without damaging surrounding normal tissues.

Conditions

Anaplastic Ependymoma

Ependymoma

Study ID

NCT03750513

Start date

Apr 1, 2019

Status verified date

May, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 22

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

48 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (LET optimized IMPT)

Patients receive LET optimized IMPT for up to 6 weeks.

Interventions

Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy

Given LET optimized IMPT

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Incidence of adverse events [ Time Frame: Up to 6 months post treatment ]

Central Contacts and Locations

Central contacts

David Grosshans

713-563-2300dgrossha@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

David R. Grosshans

713-563-2300

Principal Investigator:

David R. Grosshans

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 20, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-05-20.