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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 7, 2001 | ||||
| Last Updated Date | April 14, 2009 | ||||
| Start Date ICMJE | August 2003 | ||||
| Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Event-free survival, defined as time to disease progression, disease relapse, occurrence of second neoplasm, or death from any cause at 2 and 5 years [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Event-free survival, defined as time to disease progression, disease relapse, occurrence of second neoplasm, or death from any cause at 2 and 5 years | ||||
| Change History | Complete list of historical versions of study NCT00027846 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Overall survival, defined as time to death at 2 and 5 years [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Overall survival, defined as time to death at 2 and 5 years | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma | ||||
| Official Title ICMJE | A Phase II Trial of Conformal Radiation Therapy for Pediatric Patients With Localized Ependymoma, Chemotherapy Prior to Second Surgery for Incompletely Resected Ependymoma and Observation for Completely Resected, Differentiated, Supratentorial Ependymoma | ||||
| Brief Summary | RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase II trial to determine the effectiveness of specialized radiation therapy either alone or after chemotherapy and second surgery in treating children who have undergone surgery for localized ependymoma. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to extent of prior surgical resection.
Patients are followed every 4 months for 3 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 250-350 patients will be accrued for this study within 5 years. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Brain and Central Nervous System Tumors | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 350 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | October 2008 (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:
Other:
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| Gender | Both | ||||
| Ages | 1 Year to 21 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Australia, Canada, Netherlands, New Zealand, Switzerland | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00027846 | ||||
| Responsible Party | Gregory H. Reaman, Children's Oncology Group - Group Chair Office | ||||
| Study ID Numbers ICMJE | CDR0000069086, COG-ACNS0121 | ||||
| Study Sponsor ICMJE | Children's Oncology Group | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | October 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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