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| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | November 1, 1999 | ||||||||||||||||
| Last Updated Date | February 6, 2009 | ||||||||||||||||
| Start Date ICMJE | October 1998 | ||||||||||||||||
| Primary Completion Date | |||||||||||||||||
| Current Primary Outcome Measures ICMJE | |||||||||||||||||
| Original Primary Outcome Measures ICMJE | |||||||||||||||||
| Change History | Complete list of historical versions of study NCT00003375 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma | ||||||||||||||||
| Official Title ICMJE | A Phase II Study of Observation in Favorable Low-Grade Glioma and a Phase II Study of Radiation With or Without PCV Chemotherapy in Unfavorable Low-Grade Glioma | ||||||||||||||||
| Brief Summary | RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy combined with chemotherapy is more effective than radiation therapy alone in treating patients with low-grade glioma. PURPOSE: Phase II/III trial to evaluate observation and to compare the effectiveness of radiation therapy with or without combination chemotherapy in treating patients with low-grade glioma. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to tumor subtype (astrocytoma [mixed-astro dominant or equal astro/oligo mix] vs oligodendroglioma [mixed-oligo dominant]), age (younger than 40 vs at least 40), Karnofsky performance status (60-80% vs 90-100%), and contrast enhancement on preoperative scan (present vs absent). Patients with low-risk disease (younger than 40 years old whose tumors have been surgically removed) are assigned to arm I. Patients with high-risk disease (at least 40 years old or who have had incomplete tumor removal) are randomized to arm II or III.
Patients are followed every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 252 patients will be accrued within 5.25 years. |
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| Study Phase | Phase II, Phase III | ||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Design ICMJE | Treatment, Randomized, Active Control | ||||||||||||||||
| Condition ICMJE | Brain and Central Nervous System Tumors | ||||||||||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||||||||||
| Publications * | Shaw EG, Berkey B, Coons SW, Bullard D, Brachman D, Buckner JC, Stelzer KJ, Barger GR, Brown PD, Gilbert MR, Mehta M. Recurrence following neurosurgeon-determined gross-total resection of adult supratentorial low-grade glioma: results of a prospective clinical trial. J Neurosurg. 2008 Nov;109(5):835-41. | ||||||||||||||||
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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 | 252 | ||||||||||||||||
| Completion Date | |||||||||||||||||
| Primary Completion Date | |||||||||||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Neurological:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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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 | |||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT ID ICMJE | NCT00003375 | ||||||||||||||||
| Responsible Party | |||||||||||||||||
| Study ID Numbers ICMJE | CDR0000066367, RTOG-9802, E-R9802, NCCTG-R9802, SWOG-R9802, RTOG-DEV-1012 | ||||||||||||||||
| Study Sponsor ICMJE | Radiation Therapy Oncology Group | ||||||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||||||||||
| Verification Date | November 2002 | ||||||||||||||||
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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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