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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-05118 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P30CA138292 | U.S. NIH Grant/Contract | View source | |
| RAD4737-19 | Other Identifier | Emory University Hospital/Winship Cancer Institute |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institutes of Health (NIH) | NIH |
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This trial studies the feasibility of using intensity modulated proton therapy to deliver craniospinal irradiation while avoiding the bones of the vertebral column. Intensity modulated proton therapy is an advanced radiation therapy modality that uses high energy protons to kill cancer cells and shrink tumors, and may reduce the side effects of treatment by reducing radiation exposure to the spinal column.
PRIMARY OBJECTIVES:
I. To demonstrate the feasibility and safety of using intensity modulated proton therapy to deliver vertebral body sparing craniospinal irradiation in growing children.
Ia. To report the dose received to the vertebral bodies and the dose gradient/heterogeneity within the vertebral body.
Ib. To document, using weekly cone beam computed tomography (CT) of the cervical and lumbar spine, delivered dose in comparison with planned dose after accounting for any errors in patient positioning.
II. To evaluate acute toxicity of vertebral body sparing (VBS) craniospinal irradiation (CSI).
IIa. To report absolute lymphocyte counts over time and occurrence of grade 3-4 hematological toxicity.
IIb. To report the incidence and severity of any grade esophagitis during or within 4 weeks of radiation therapy.
III. To evaluate the feasibility of magnetic resonance imaging (MRI) imaging during CSI therapy as in vivo proton range verification.
IIIa. To demonstrate the feasibility of completing interim non-contrast MRIs of the spine during treatment.
IIIb. To characterize the earliest time point at which radiation induced bone marrow changes can be detected in children receiving proton CSI.
OUTLINE:
Patients undergo intensity modulated proton therapy once daily over 30 fractions and also undergo MRI over 20 minutes during fractions 7, 13, 20, and 30 of radiation in the absence of disease progression or unacceptable toxicity.
After the completion of study treatment, patients are followed up at 4 weeks and then every 3-12 months thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (intensity modulated proton therapy) | Experimental | Patients undergo intensity modulated proton therapy once daily over 30 fractions and also undergo MRI over 20 minutes during fractions 7, 13, 20, and 30 of radiation in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensity-Modulated Proton Therapy | Procedure | Undergo intensity modulated proton therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of acute hematologic toxicity | Will be graded according to Common Terminology Criteria for Adverse Events version 5.0. | Up to 2 years |
| Dose delivered to vertebral bodies and quality assurance of treatment plans | Multiple measurements will be aggregated to arrive at one reported value when toxicities are graded (1-5). Dose statistics are in units of Gy or may be % | Up to 2 years |
| Bone marrow changes on MRI | Will be quantitatively and qualitatively analyzed in relationship to the proton dose distribution | At baseline, and fractions 7, 13, 20, and 30 of radiation therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bree R Eaton | Emory University Hospital/Winship Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Proton Therapy Center | Atlanta | Georgia | 30308 | United States | ||
| Emory University Hospital/Winship Cancer Institute |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 1, 2019 | Apr 28, 2023 |
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| Magnetic Resonance Imaging | Procedure | Undergo MRI |
|
|
| Atlanta |
| Georgia |
| 30322 |
| United States |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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