Radiotherapy or Radiosurgery Compared With Observation Alone in Treating Patients With Newly Diagnosed, Benign Meningioma That Has Been Partially Removed by Surgery
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First Received Date ICMJE | March 3, 2005 | ||||||||||||||||
Last Updated Date | September 20, 2012 | ||||||||||||||||
Start Date ICMJE | December 2004 | ||||||||||||||||
Primary Completion Date | November 2006 (final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
Progression-free survival [ Designated as safety issue: No ] | ||||||||||||||||
Original Primary Outcome Measures ICMJE |
Progression-free survival | ||||||||||||||||
Change History | Complete list of historical versions of study NCT00104936 on ClinicalTrials.gov Archive Site | ||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||||||||||||||
Original Other Outcome Measures ICMJE | |||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | Radiotherapy or Radiosurgery Compared With Observation Alone in Treating Patients With Newly Diagnosed, Benign Meningioma That Has Been Partially Removed by Surgery | ||||||||||||||||
Official Title ICMJE | Observation Versus Conventional-Fractionated Radiotherapy or Radiosurgery After Non-radical Surgery for Benign Intracranial Meningiomas: A Phase III Study | ||||||||||||||||
Brief Summary | RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving radiation therapy or radiosurgery after surgery may kill any remaining tumor cells. It is not yet known whether radiation therapy or radiosurgery is more effective than observation alone in treating benign meningioma. PURPOSE: This randomized phase III trial is studying radiation therapy or radiosurgery to see how well they work compared to observation alone in treating patients with newly diagnosed, benign meningioma that has been partially removed by surgery. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to post-surgery MRI staging (3 vs 4 vs 5), skull base location (yes vs no), age (< 60 vs ≥ 60), and participating center. Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline, at 6 months after randomization, and then annually thereafter. After completion of study treatment, patients are followed at 3 and 6 months after randomization and then annually thereafter. PROJECTED ACCRUAL: A total of 478 patients (239 per treatment arm) will be accrued for this study within 3-4 years. |
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Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase | Phase 3 | ||||||||||||||||
Study Design ICMJE | Allocation: Randomized Primary Purpose: Treatment |
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Condition ICMJE | Brain and Central Nervous System Tumors | ||||||||||||||||
Intervention ICMJE |
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Study Arm (s) | |||||||||||||||||
Publications * | |||||||||||||||||
* 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 | Terminated | ||||||||||||||||
Enrollment ICMJE | 9 | ||||||||||||||||
Completion Date | |||||||||||||||||
Primary Completion Date | November 2006 (final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||||||||||||||
Ages | 18 Years and older | ||||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
Location Countries ICMJE | Germany, Netherlands, Switzerland | ||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT00104936 | ||||||||||||||||
Other Study ID Numbers ICMJE | EORTC-26021 -22021, EORTC-26021, EORTC-22021, CAN-NCIC-EORTC-26021 | ||||||||||||||||
Has Data Monitoring Committee | |||||||||||||||||
Responsible Party | European Organization for Research and Treatment of Cancer - EORTC | ||||||||||||||||
Study Sponsor ICMJE | European Organization for Research and Treatment of Cancer - EORTC | ||||||||||||||||
Collaborators ICMJE | NCIC Clinical Trials Group | ||||||||||||||||
Investigators ICMJE |
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Information Provided By | European Organization for Research and Treatment of Cancer - EORTC | ||||||||||||||||
Verification Date | September 2012 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |