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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source | |
| U19CA021239 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (LET optimized IMPT) | Experimental | Patients receive LET optimized IMPT for up to 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy | Radiation | Given LET optimized IMPT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | 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. | Up to 6 months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Identify imaging biomarkers of structural and biological changes after proton therapy | Descriptive statistics will be used to summarize the study data. | Up to 24 months post-treatment |
| Quantitative image biomarkers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Grosshans | Contact | 713-563-2300 | dgrossha@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| David R Grosshans | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Not yet recruiting | Boston | Massachusetts | 02114 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D004806 | Ependymoma |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| D018499 | Linear Energy Transfer |
| ID | Term |
|---|---|
| D004735 | Energy Transfer |
| D055592 | Biophysical Phenomena |
| D055585 | Physical Phenomena |
| D001669 | Biochemical Phenomena |
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| Quality-of-Life Assessment | Other | Ancillary studies |
|
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| Questionnaire Administration | Other | Ancillary studies |
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Descriptive statistics will be used to summarize the study data.
| Up to 24 months post-treatment |
| Validity of relative biological effectiveness models | Descriptive statistics will be used to summarize the study data. | Up to 24 months post-treatment |
| Incidence of late and acute toxicities | 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. | Up to 24 months post treatment |
| Progression-free survival | The method of Kaplan and Meier will be used to provide estimates. | Up to 24 months post treatment |
| Overall survival | The method of Kaplan and Meier will be used to provide estimates. | Up to 24 months post treatment |
| Disease outcomes following the use of a simultaneous integrated boost | Descriptive statistics will be used to summarize the study data. | Up to 24 months post-treatment |
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D055598 |
| Chemical Phenomena |