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NCT00626990 · ClinicalTrials.gov registry record · Phase 3
Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH)
A Phase 3 study of Brain and Central Nervous System Tumors, sponsored by European Organisation for Research and Treatment of Cancer - EORTC.
- Active
- Registry status
- Phase 3
- Development phase
- 751
- Enrollment target
- 20
- Study locations
NCT00626990: Active Phase 3 study of Brain and Central Nervous System Tumors, sponsored by European Organisation for Research and Treatment of Cancer - EORTC.
NCT00626990 is a Phase 3 study of Brain and Central Nervous System Tumors that is active but no longer recruiting, run by European Organisation for Research and Treatment of Cancer - EORTC. The registered enrollment target is 751 participants, above the 167-participant average among 45 other Brain and Central Nervous System Tumors trials with a reported enrollment target (350% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00626990, a Phase 3 study of Brain and Central Nervous System Tumors, is active but no longer recruiting, sponsored by European Organisation for Research and Treatment of Cancer - EORTC.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 751 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma. PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy alone in treating patients with anaplastic glioma.
Primary Outcome
The duration of survival is the time interval between randomization and the date of death due to any cause. Patients not reported dead or lost to follow up will be censored at the date of the last follow up examination.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG temozolomide
- PROCEDURE quality-of-life assessment
- GENETIC DNA methylation analysis
- PROCEDURE adjuvant therapy
Study Locations (20)
Florida
- University of Florida - Gainesville
- Mayo Clinic in Florida - Jacksonville
- Florida Hospital - Orlando
Indiana
- Oncology Associates PC - Fort Wayne
- Parkview Hospital - Fort Wayne
- Saint Vincent Oncology Center - Indianapolis
California
- Cedars-Sinai Medical Center - Los Angeles
- UCSF University of California San Francisco Medical Center-Mount Zion - San Francisco
Georgia
- Emory University - Atlanta
- Memorial Health University Medical Center - Savannah
Illinois
- Northwestern University - Chicago
- Loyola University Medical Center - Maywood
Iowa
- McFarland Clinic - Ames
- June E. Nylen Cancer Center - Sioux City
Kansas
- Via Christi Regional Medical Center - Wichita
- Wesley Medical Center - Wichita
Massachusetts
- Boston Medical Center - Boston
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 751 participants |
| Start Date | 2007-12 |
| Est. Completion | 2029-12 |
| Phase | Phase 3 |
What the registry record for NCT00626990 still lists
NCT00626990 is an interventional study that assigns participants to a tested intervention. The registered 751 participants enrollment target is mid-sized for trials with a published cap, above the 167-participant average among 45 other Brain and Central Nervous System Tumors trials with a reported enrollment target (350% higher).
The record links to 1 condition, with Brain and Central Nervous System Tumors appearing as the primary indexed condition, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT00626990 names 20 study sites across 10 states, led by Florida, Indiana, California.
Frequently Asked Questions
What is clinical trial NCT00626990 about?
NCT00626990 is a clinical study titled "Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH)". RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Giving radiation therapy together with temozolomide may...
What is the current status of trial NCT00626990?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 751 participants. The study started on 2007-12. Estimated completion is 2029-12.
What conditions does trial NCT00626990 study?
This clinical trial studies the following conditions: Brain and Central Nervous System Tumors.
What interventions are being tested in trial NCT00626990?
The interventions under investigation include: laboratory biomarker analysis (OTHER), temozolomide (DRUG), quality-of-life assessment (PROCEDURE), DNA methylation analysis (GENETIC), adjuvant therapy (PROCEDURE).
Who is sponsoring clinical trial NCT00626990?
This trial is sponsored by European Organisation for Research and Treatment of Cancer - EORTC, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00626990 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00626990's enrollment target sits among peer trials
751 2nd of 45 the highest 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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