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NCT00978458 · ClinicalTrials.gov registry record · Phase 3
Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma
A Phase 3 study of Brain and Central Nervous System Tumors and Neurotoxicity, sponsored by Eastern Cooperative Oncology Group.
- Active
- Registry status
- Phase 3
- Development phase
- 540
- Enrollment target
- 20
- Study locations
NCT00978458: Active Phase 3 study of Brain and Central Nervous System Tumors and Neurotoxicity, sponsored by Eastern Cooperative Oncology Group.
NCT00978458 is a Phase 3 study of Brain and Central Nervous System Tumors and Neurotoxicity that is active but no longer recruiting, run by Eastern Cooperative Oncology Group. The registered enrollment target is 540 participants, above the 172-participant average among 45 other Brain and Central Nervous System Tumors trials with a reported enrollment target (214% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00978458, a Phase 3 study of Brain and Central Nervous System Tumors and Neurotoxicity, is active but no longer recruiting, sponsored by Eastern Cooperative Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 540 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with or without temozolomide in treating patients with low-grade glioma. PURPOSE: This randomized phase III trial is studying radiation therapy so see how well it works when given together with or without temozolomide in treating patients with low-grade glioma.
Conditions Studied
Interventions
- DRUG temozolomide
- RADIATION intensity-modulated radiation therapy
- RADIATION 3-dimensional conformal radiation therapy
Study Locations (20)
Colorado
- Aurora Presbyterian Hospital - Aurora
- St. Anthony Central Hospital - Denver
- Porter Adventist Hospital - Denver
- Presbyterian - St. Luke's Medical Center - Denver
- St. Joseph Hospital - Denver
- CCOP - Colorado Cancer Research Program - Denver
- Swedish Medical Center - Englewood
- Sky Ridge Medical Center - Lone Tree
Illinois
- Illinois CancerCare - Bloomington - Bloomington
- St. Joseph Medical Center - Bloomington
- Graham Hospital - Canton
California
- Rebecca and John Moores UCSD Cancer Center - La Jolla
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center - Orange
Florida
- Mayo Clinic - Jacksonville - Jacksonville
- Florida Hospital Cancer Institute at Florida Hospital Orlando - Orlando
Alabama
- UAB Comprehensive Cancer Center - Birmingham
Arizona
- Arizona Oncology Services Foundation - Phoenix
Connecticut
- Eastern Connecticut Hematology and Oncology Associates - Norwich
Delaware
- CCOP - Christiana Care Health Services - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 540 participants |
| Start Date | 2009-11-17 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
What the registry record for NCT00978458 still lists
NCT00978458 is an interventional study that assigns participants to a tested intervention. The registered 540 participants enrollment target is mid-sized for trials with a published cap, above the 172-participant average among 45 other Brain and Central Nervous System Tumors trials with a reported enrollment target (214% higher).
The record links to 2 conditions, with Brain and Central Nervous System Tumors appearing as the primary indexed condition, and to 3 interventions - of which temozolomide is the first listed.
NCT00978458 names 20 study sites across 9 states, led by Colorado, Illinois, California.
Frequently Asked Questions
What is clinical trial NCT00978458 about?
NCT00978458 is a clinical study titled "Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma". RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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, such as temozolomide, work in different w...
What is the current status of trial NCT00978458?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 540 participants. The study started on 2009-11-17. Estimated completion is 2026-12-31.
What conditions does trial NCT00978458 study?
This clinical trial studies the following conditions: Brain and Central Nervous System Tumors, Neurotoxicity.
What interventions are being tested in trial NCT00978458?
The interventions under investigation include: temozolomide (DRUG), intensity-modulated radiation therapy (RADIATION), 3-dimensional conformal radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT00978458?
This trial is sponsored by Eastern Cooperative Oncology Group, which has 141 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00978458 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00978458's enrollment target sits among peer trials
540 4th of 45 higher than 42 of 45 other Brain and Central Nervous System Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain and Central Nervous System Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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