Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma
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ClinicalTrials.gov Identifier: NCT00003375 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : October 19, 2020
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Tracking Information | |||||||||||||
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First Submitted Date ICMJE | November 1, 1999 | ||||||||||||
First Posted Date ICMJE | January 27, 2003 | ||||||||||||
Last Update Posted Date | October 19, 2020 | ||||||||||||
Study Start Date ICMJE | October 1998 | ||||||||||||
Actual Primary Completion Date | August 2005 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
Overall Survival [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years or 80 deaths have been reported. ] | ||||||||||||
Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
Change History | |||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
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 Type ICMJE | Interventional | ||||||||||||
Study Phase ICMJE | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: 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 ICMJE |
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Publications * |
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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 | Completed | ||||||||||||
Actual Enrollment ICMJE |
370 | ||||||||||||
Original Enrollment ICMJE | Not Provided | ||||||||||||
Actual Study Completion Date ICMJE | May 14, 2018 | ||||||||||||
Actual Primary Completion Date | August 2005 (Final data collection date for primary outcome measure) | ||||||||||||
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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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 120 Years (Adult, Older Adult) | ||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries ICMJE | Not Provided | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT00003375 | ||||||||||||
Other Study ID Numbers ICMJE | RTOG-9802 CDR0000066367 E-R9802 NCCTG-R9802 SWOG-R9802 |
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Has Data Monitoring Committee | Yes | ||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||||||||
Current Responsible Party | Radiation Therapy Oncology Group | ||||||||||||
Original Responsible Party | Not Provided | ||||||||||||
Current Study Sponsor ICMJE | Radiation Therapy Oncology Group | ||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Radiation Therapy Oncology Group | ||||||||||||
Verification Date | May 2018 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |