Radiation Therapy in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Grade II or Grade III Meningioma
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | February 28, 2008 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | December 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Progression-free survival [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00626730 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Radiation Therapy in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Grade II or Grade III Meningioma | ||||
| Official Title ICMJE | Adjuvant Postoperative High-Dose Radiotherapy for Atypical and Malignant Meningioma: a Phase-II and Observation Study | ||||
| Brief Summary | RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving high-dose radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying radiation therapy to see how well it works in treating patients who have undergone surgery for newly diagnosed grade II or grade III meningioma. |
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| Detailed Description | OBJECTIVES: Primary
OUTLINE: Patients with grade II disease are stratified according to resection status (complete excision [Simpson's stages 1-3] vs incomplete excision [Simpson's stages 4-5]) and participate in a phase II study. These patients are assigned to 1 of 2 treatment groups according to Simpson staging. Only data from these patients is analyzed with respect to the progression-free survival endpoint. Patients with grade III disease are treated in group 1 or 2 according to Simpson staging (as patients with grade II disease). After treatment, the clinical results from these patients are observed and described.
Patients complete a Mini-Mental Status Exam at baseline and at 6 weeks and 6 months after completion of study. After completion of study treatment, patients are followed at 6 weeks, at 6 and 12 months, and then annually for at least 3 years. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-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) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* 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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 77 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Switzerland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00626730 | ||||
| Other Study ID Numbers ICMJE | CDR0000583070, EORTC-22042, EORTC-26042, EudraCT-2005-005551-18 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | European Organisation for Research and Treatment of Cancer - EORTC | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | February 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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