LET Optimized IMPT in Treating Pediatric Patients With Ependymoma

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    48
  • sponsor
    M.D. Anderson Cancer Center
Updated on 3 February 2022
ependymoma
tumor cells

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.

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:

I. To utilize advanced multiparametric magnetic resonance (MR) imaging to identify imaging biomarkers of structural and biological changes after proton therapy in pediatric ependymoma patients.

II. To compare quantitative image biomarkers in patients treated with bio-IMPT and standard proton therapy using a voxel level analysis.

III. To test and evaluate the validity of relative biological effectiveness (RBE) models and enhance their precision based on prospectively collected clinical image biomarkers.

IV. To evaluate acute and late toxicities, including pseudoprogression and symptom burden, in patients treated with bio-IMPT.

V. To estimate progression-free survival (PFS) and overall survival (OS). VI. To evaluate disease outcomes following the use of a simultaneous integrated boost (SIB) for pediatric ependymoma patients with gross residual disease following surgery.

OUTLINE

Patients receive LET optimized IMPT for up to 6 weeks.

After completion of study treatment, patients are followed up at 1 month, then every 3 months for up to 24 months.

Details
Condition Anaplastic Ependymoma, Ependymoma
Treatment questionnaire administration, quality-of-life assessment, Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy
Clinical Study IdentifierNCT03750513
SponsorM.D. Anderson Cancer Center
Last Modified on3 February 2022

Eligibility

Yes No Not Sure

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
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