Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00943826 · ClinicalTrials.gov registry record · Phase 3
A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma
A Phase 3 study of Glioblastoma, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 921
- Enrollment target
- 20
- Study locations
NCT00943826 is a Phase 3 study of Glioblastoma that has completed, run by Hoffmann-La Roche. The registered enrollment target is 921 participants, above the 104-participant average among 199 other Glioblastoma trials with a reported enrollment target (786% higher). The trial reports 20 study locations across 15 states.
The verdict
NCT00943826, a Phase 3 study of Glioblastoma, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 921 participants
- Enrollment target
- 20
- Study locations
Study Summary
This 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide) as compared to the current standard of care alone. Participants were randomly assigned to either the bevacizumab (10 milligrams per kilogram (mg/kg) intravenously \[IV\] once every 2 week \[q2w\]) or the placebo arm, in combination with radiation therapy (total dose 60 Gray \[Gy\], administered as 2 Gy fractions, 5 days/week) plus temozolomide (75 milligrams per meter squared \[mg/m\^2\] oral administration \[po\] daily) for 6 weeks. After a 4 week treatment break, participants continued to receive bevacizumab (10 mg/kg IV q2w) or placebo, plus temozolomide (150-200 mg/m\^2 po daily on days 1-5 of each 4 week cycle) for 6 cycles of maintenance treatment or until disease progression or unacceptable toxicity, whichever occured first. Following the maintenance phase, bevacizumab (15 mg/kg iv every 3 weeks \[q3w\]) or placebo monotherapy continued. The time on study treatment was until disease progression.
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Placebo
- DRUG Temozolomide
- RADIATION Radiation therapy
Study Locations (20)
Other
- Clin Univ de Bxl Hôpital Erasme - Brussels
- Cliniques Universitaires St-Luc - Brussels
- UZ Antwerpen - Edegem
- AZ Sint Lucas (Sint Lucas) - Ghent
New South Wales
- Prince of Wales Hospital; Department of Medical Oncology - Randwick
- North Shore Private Hospital; Northern Specialist Centre - St Leonards
- Royal North Shore Hospital; Department of Medical Oncology - St Leonards
Alabama
- University of Alabama At Birmingham; Neuro-Oncology - Birmingham
California
- UCLA - Los Angeles
Colorado
- University of Colorado - Aurora
Florida
- Moffitt Cancer Center - Tampa
Illinois
- Oncology-Evanston Nthwest Healthcare Kellogg Cancer Care Ctr - Evanston
Michigan
- Henry Ford Health System - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 921 participants |
| Start Date | 2009-06-29 |
| Est. Completion | 2015-09-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00943826
The ClinicalTrials.gov registry entry for NCT00943826 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 921 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 104-participant average among 199 other Glioblastoma trials with a reported enrollment target (786% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Glioblastoma appearing as the primary indexed condition, and to 4 interventions - of which Bevacizumab is the first listed.
NCT00943826 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Other, New South Wales, Alabama.
Frequently Asked Questions
What is clinical trial NCT00943826 about?
NCT00943826 is a clinical study titled "A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma". This 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide) as compared to the current standard of care alone. Participants were randomly as...
What is the current status of trial NCT00943826?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 921 participants. The study started on 2009-06-29. Estimated completion is 2015-09-09.
What conditions does trial NCT00943826 study?
This clinical trial studies the following conditions: Glioblastoma.
What interventions are being tested in trial NCT00943826?
The interventions under investigation include: Bevacizumab (DRUG), Placebo (DRUG), Temozolomide (DRUG), Radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT00943826?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00943826 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Glioblastoma
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.
-
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
RECRUITING · Phase 3
-
A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma
RECRUITING · Phase 3
-
Advanced Imaging Techniques for Evaluating the Tumor Immune Microenvironment in Glioblastoma Patients
RECRUITING · Phase 3
-
Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM
RECRUITING · Phase 3
-
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
RECRUITING · Phase 3
-
Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme
ACTIVE NOT RECRUITING · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
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.