Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
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ClinicalTrials.gov Identifier: NCT00085202 |
Recruitment Status
:
Active, not recruiting
First Posted
: June 11, 2004
Results First Posted
: February 27, 2014
Last Update Posted
: January 23, 2018
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Tracking Information | |||||
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First Submitted Date ICMJE | June 10, 2004 | ||||
First Posted Date ICMJE | June 11, 2004 | ||||
Results First Submitted Date | November 4, 2013 | ||||
Results First Posted Date | February 27, 2014 | ||||
Last Update Posted Date | January 23, 2018 | ||||
Study Start Date ICMJE | August 2003 | ||||
Actual Primary Completion Date | December 2016 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Not Provided | ||||
Change History | Complete list of historical versions of study NCT00085202 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor | ||||
Official Title ICMJE | Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor | ||||
Brief Summary | Drugs used in chemotherapy, such as vincristine, cisplatin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. It is not yet known which radiation therapy regimen combined with chemotherapy and donor stem cell transplant is more effective in treating medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor. This phase III trial is studying two different regimens of radiation therapy when given together with chemotherapy and autologous stem cell transplant to see how well they work in treating patients with newly diagnosed medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor. PRIMARY OBJECTIVE:
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Detailed Description | SECONDARY OBJECTIVES:
EXPLORATORY OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to disease risk (high-risk disease vs average-risk disease). Patients in both strata undergo peripheral blood stem cell or bone marrow harvest.
Some patients undergo a neuropsychology assessment at baseline, before chemotherapy, and then annually for 5 years. After completion of study therapy, patients are followed every 3 months until month 30 (2.5 years) after diagnosis and then every 6 months until month 72 (6 years) after diagnosis. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Brain and Central Nervous System Tumors | ||||
Intervention ICMJE |
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Study Arms |
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Publications * | Xu H, Robinson GW, Huang J, Lim JY, Zhang H, Bass JK, Broniscer A, Chintagumpala M, Bartels U, Gururangan S, Hassall T, Fisher M, Cohn R, Yamashita T, Teitz T, Zuo J, Onar-Thomas A, Gajjar A, Stewart CF, Yang JJ. Common variants in ACYP2 influence susceptibility to cisplatin-induced hearing loss. Nat Genet. 2015 Mar;47(3):263-6. doi: 10.1038/ng.3217. Epub 2015 Feb 9. Erratum in: Nat Genet. 2015 Apr;47(4):423. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
416 | ||||
Original Enrollment ICMJE | Not Provided | ||||
Estimated Study Completion Date | January 2023 | ||||
Actual Primary Completion Date | December 2016 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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Sex/Gender |
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Ages | 3 Years to 21 Years (Child, Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Australia, Canada, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00085202 | ||||
Other Study ID Numbers ICMJE | SJMB03 NCI-2011-01185 ( Registry Identifier: NCI Clinical Trial Registration Program ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | St. Jude Children's Research Hospital | ||||
Study Sponsor ICMJE | St. Jude Children's Research Hospital | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | St. Jude Children's Research Hospital | ||||
Verification Date | December 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |