LET Optimized IMPT in Treating Pediatric Patients With Ependymoma
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| ClinicalTrials.gov Identifier: NCT03750513 |
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Recruitment Status :
Recruiting
First Posted : November 22, 2018
Last Update Posted : June 12, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anaplastic Ependymoma Ependymoma | Radiation: Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration | Phase 1 |
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.
| Study Type : | Interventional |
| Estimated Enrollment : | 48 participants |
| 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 : | April 1, 2019 |
| Estimated Primary Completion Date : | May 31, 2020 |
| Estimated Study Completion Date : | May 31, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment (LET optimized IMPT)
Patients receive LET optimized IMPT for up to 6 weeks.
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Radiation: Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy
Given LET optimized IMPT
Other Names:
Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies |
- Incidence of adverse events [ Time Frame: 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.
- Identify imaging biomarkers of structural and biological changes after proton therapy [ Time Frame: Up to 24 months post-treatment ]Descriptive statistics will be used to summarize the study data.
- Quantitative image biomarkers [ Time Frame: Up to 24 months post-treatment ]Descriptive statistics will be used to summarize the study data.
- Validity of relative biological effectiveness models [ Time Frame: Up to 24 months post-treatment ]Descriptive statistics will be used to summarize the study data.
- Incidence of late and acute toxicities [ Time Frame: 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.
- Progression-free survival [ Time Frame: Up to 24 months post treatment ]The method of Kaplan and Meier will be used to provide estimates.
- Overall survival [ Time Frame: Up to 24 months post treatment ]The method of Kaplan and Meier will be used to provide estimates.
- Disease outcomes following the use of a simultaneous integrated boost [ Time Frame: Up to 24 months post-treatment ]Descriptive statistics will be used to summarize the study data.
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| Ages Eligible for Study: | up to 22 Years (Child, Adult) |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750513
| Contact: David Grosshans | 713-563-2300 | dgrossha@mdanderson.org |
| United States, Massachusetts | |
| Massachusetts General Hospital Cancer Center | Not yet recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Jacqueline Lewy jlewy@mgh.harvard.edu | |
| Principal Investigator: Shannon M. MacDonald | |
| United States, Texas | |
| M D Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: David R. Grosshans 713-563-2300 | |
| Principal Investigator: David R. Grosshans | |
| Principal Investigator: | David R Grosshans | M.D. Anderson Cancer Center |
Additional Information:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT03750513 History of Changes |
| Other Study ID Numbers: |
2018-0344 NCI-2018-02519 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2018-0344 ( Other Identifier: M D Anderson Cancer Center ) P30CA016672 ( U.S. NIH Grant/Contract ) U19CA021239 ( U.S. NIH Grant/Contract ) |
| First Posted: | November 22, 2018 Key Record Dates |
| Last Update Posted: | June 12, 2019 |
| Last Verified: | June 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Ependymoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |