Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00004259 · ClinicalTrials.gov registry record · Phase 3
Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas
A Phase 3 study of Brain and Central Nervous System Tumors, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 230
- Enrollment target
- 20
- Study locations
NCT00004259: Completed Phase 3 study of Brain and Central Nervous System Tumors, sponsored by Radiation Therapy Oncology Group.
NCT00004259 is a Phase 3 study of Brain and Central Nervous System Tumors that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 230 participants, above the 179-participant average among 45 other Brain and Central Nervous System Tumors trials with a reported enrollment target (28% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00004259, a Phase 3 study of Brain and Central Nervous System Tumors, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 230 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as temozolomide, carmustine, and lomustine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: This randomized phase III trial is studying radiation therapy and temozolomide to see how well they work compared to radiation therapy and carmustine or lomustine in treating patients with anaplastic astrocytoma or mixed gliomas.
Primary Outcome
Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Per the protocol, the pilot arms were not included in the Phase III analyses.
Conditions Studied
Interventions
- RADIATION radiation therapy
- DRUG CCNU
- DRUG BCNU 80mg/m2
- DRUG TMZ 200mg/m2
- DRUG BCNU 150mg/m2
Study Locations (20)
Florida
- Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center - Boca Raton
- University of Florida Shands Cancer Center - Gainesville
- Baptist Cancer Institute - Jacksonville - Jacksonville
- Florida Oncology Associates at Southside Cancer Center - Jacksonville
- Baptist Medical Center South - Jacksonville
- Integrated Community Oncology Network - Jacksonville Beach
- Florida Oncology Associates - Orange Park
- Florida Cancer Center - Palatka - Palatka
- Flagler Cancer Center - Saint Augustine
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida - Tampa
Illinois
- St. Joseph Medical Center - Bloomington
- Graham Hospital - Canton
- Memorial Hospital - Carthage
- Eureka Community Hospital - Eureka
California
- Enloe Cancer Center at Enloe Medical Center - Chico
- North Bay Cancer Center - Fairfield
- Solano Radiation Oncology Center - Vacaville
Alabama
- Mobile Infirmary Medical Center - Mobile
Arizona
- Arizona Oncology Services Foundation - Phoenix
Georgia
- John B. Amos Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2000-06 |
| Est. Completion | 2018-05-14 |
| Phase | Phase 3 |
What the finished NCT00004259 record still lists
NCT00004259 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, above the 179-participant average among 45 other Brain and Central Nervous System Tumors trials with a reported enrollment target (28% 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 radiation therapy is the first listed.
NCT00004259 names 20 study sites across 6 states, led by Florida, Illinois, California.
Frequently Asked Questions
What is clinical trial NCT00004259 about?
NCT00004259 is a clinical study titled "Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas". RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as temozolomide, carmustine, and lomustine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor...
What is the current status of trial NCT00004259?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 230 participants. The study started on 2000-06. Estimated completion is 2018-05-14.
What conditions does trial NCT00004259 study?
This clinical trial studies the following conditions: Brain and Central Nervous System Tumors.
What interventions are being tested in trial NCT00004259?
The interventions under investigation include: radiation therapy (RADIATION), CCNU (DRUG), BCNU 80mg/m2 (DRUG), TMZ 200mg/m2 (DRUG), BCNU 150mg/m2 (DRUG).
Who is sponsoring clinical trial NCT00004259?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00004259 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Brain and Central Nervous System Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00004259's enrollment target sits among peer trials
230 10th of 45 higher than 36 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma
ACTIVE NOT RECRUITING · Phase 3
-
Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH)
ACTIVE NOT RECRUITING · Phase 3
-
Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma
ACTIVE NOT RECRUITING · Phase 3
-
SU-101 Compared With Procarbazine in Treating Patients With Glioblastoma Multiforme
COMPLETED · Phase 3
-
Opioid Titration Order Sheet or Standard Care in Treating Patients With Cancer Pain
COMPLETED · Phase 3
-
Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02710253 · 230 participants · Phase 2
Salvage Radiation Therapy in Treating Patients With Metastatic Cancer That Has Progressed After Systemic Immunotherapy
- NCT02777879 · 230 participants
Lung Microbiome and Inflammation in Early COPD
- NCT03824483 · 230 participants · Phase 2
Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL)
- NCT03833622 · 230 participants · NA
Shared Decision Making to Improve Goals of Care in the ED
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia