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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 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.

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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.

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

FieldValue
Enrollment Target 230 participants
Start Date 2000-06
Est. Completion 2018-05-14
Phase Phase 3

Sponsor

Radiation Therapy Oncology Group

144 total trials

What the Registry Record Tells You About NCT00004259

The ClinicalTrials.gov registry entry for NCT00004259 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 179-participant average among 45 other Brain and Central Nervous System Tumors trials with a reported enrollment target (28% higher). The listed sponsor is Radiation Therapy Oncology Group, which has 144 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.

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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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.