Clincosm LogoSign in Get a demo

LET Optimized IMPT in Treating Pediatric Patients With Ependymoma

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03750513
Collaborator
National Cancer Institute (NCI) (NIH)
48
Enrollment
2
Locations
1
Arm
50
Anticipated Duration (Months)
24
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
 Phase 1

Detailed Description

PRIMARY OBJECTIVES:
  1. To evaluate the safety of linear energy transfer (LET) optimized image modulated proton therapy (IMPT) (bio-IMPT) for pediatric patients with ependymoma.
SECONDARY OBJECTIVES:

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

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

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

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

  5. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Trial of LET Optimized IMPT for Pediatric Patients With Ependymoma
Actual Study Start Date :
Apr 1, 2019
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (LET optimized IMPT)

Patients receive LET optimized IMPT for up to 6 weeks.

Radiation: Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy
Given LET optimized IMPT
Other Names:
  • LET-Optimized IMPT
  • LET-Optimized Intensity Modulated Proton Therapy
  • Linear Energy Transfer (LET)-Optimized Intensity Modulated Proton Therapy (IMPT)

    • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events [Up to 6 months post treatment]

      The safety of linear energy transfer-optimized intensity modulated proton therapy will be defined by treatment failures which include imaging changes consistent with necrosis in the presence of Common Terminology Criteria for Adverse Events version 4.03 symptoms of grade 3 brain necrosis and/or local recurrence within the first 6 months from the end of proton therapy.

    Secondary Outcome Measures

    1. Identify imaging biomarkers of structural and biological changes after proton therapy [Up to 24 months post-treatment]

      Descriptive statistics will be used to summarize the study data.

    2. Quantitative image biomarkers [Up to 24 months post-treatment]

      Descriptive statistics will be used to summarize the study data.

    3. Validity of relative biological effectiveness models [Up to 24 months post-treatment]

      Descriptive statistics will be used to summarize the study data.

    4. Incidence of late and acute toxicities [Up to 24 months post treatment]

      Descriptive statistics will be used to summarize the study data. For each study cohort, we will tabulate treatment- failures and other relevant clinically-related features. Interval estimates for proportions will be provided using exact 95% confidence intervals.

    5. Progression-free survival [Up to 24 months post treatment]

      The method of Kaplan and Meier will be used to provide estimates.

    6. Overall survival [Up to 24 months post treatment]

      The method of Kaplan and Meier will be used to provide estimates.

    7. Disease outcomes following the use of a simultaneous integrated boost [Up to 24 months post-treatment]

      Descriptive statistics will be used to summarize the study data.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 22 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    2 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: David R Grosshans, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT03750513
    Other Study ID Numbers:
    • 2018-0344
    • NCI-2018-02519
    • 2018-0344
    • P30CA016672
    • U19CA021239
    First Posted:
    Nov 23, 2018
    Last Update Posted:
    Jan 14, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Ependymoma

    Study Results

    No Results Posted as of Jan 14, 2021