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NCT00597402 · ClinicalTrials.gov registry record · Phase 2
Avastin in Combination With Radiation (XRT) & Temozolomide, Followed by Avastin, Temozolomide and Irinotecan for Glioblastoma (GBM) and Gliosarcomas
A Phase 2 study of Glioblastoma and Brain Tumor, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 125
- Enrollment target
- 1
- Study location
NCT00597402: Completed Phase 2 study of Glioblastoma and Brain Tumor, sponsored by Duke University.
NCT00597402 is a Phase 2 study of Glioblastoma and Brain Tumor that has completed, run by Duke University. The registered enrollment target is 125 participants, above the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (16% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00597402, a Phase 2 study of Glioblastoma and Brain Tumor, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 125 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary objective: To use overall survival to assess the efficacy of the combination of radiation therapy, temozolomide and Avastin followed by Avastin, temozolomide, and irinotecan in the treatment of grade IV malignant glioma patients following surgical resection. Secondary objective: To determine the progression-free survival following the combination of radiation therapy, temozolomide and Avastin followed by Avastin, temozolomide, and irinotecan. Exploratory Objective: To explore the relationship between biomarkers and outcome (overall survival and progression-free survival) among patients with grade IV malignant glioma treated with radiation therapy, temozolomide and Avastin followed by Avastin, temozolomide, and irinotecan. To describe the toxicity of radiation therapy,temozolomide and Avastin followed by Avastin, temozolomide, and irinotecan.
Primary Outcome
Percentage of participants surviving sixteen months from the start of study treatment. OS was defined as the time from the date of study treatment initiation to the date of death due to any cause.
Conditions Studied
Interventions
- DRUG Temozolomide
- DRUG Irinotecan
- DRUG Avastin
- RADIATION Radiation Therapy (XRT)
Study Locations (1)
North Carolina
- Duke University Health System - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2007-07 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
What the finished NCT00597402 record still lists
NCT00597402 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, above the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (16% higher).
The record links to 3 conditions, with Glioblastoma appearing as the primary indexed condition, and to 4 interventions - of which Temozolomide is the first listed.
NCT00597402 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT00597402 about?
NCT00597402 is a clinical study titled "Avastin in Combination With Radiation (XRT) & Temozolomide, Followed by Avastin, Temozolomide and Irinotecan for Glioblastoma (GBM) and Gliosarcomas". Primary objective: To use overall survival to assess the efficacy of the combination of radiation therapy, temozolomide and Avastin followed by Avastin, temozolomide, and irinotecan in the treatment of grade IV malignant glioma patients following surgical resection. Secondary objective: To determin...
What is the current status of trial NCT00597402?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2007-07. Estimated completion is 2013-05.
What conditions does trial NCT00597402 study?
This clinical trial studies the following conditions: Glioblastoma, Brain Tumor, Gliosarcoma.
What interventions are being tested in trial NCT00597402?
The interventions under investigation include: Temozolomide (DRUG), Irinotecan (DRUG), Avastin (DRUG), Radiation Therapy (XRT) (RADIATION).
Who is sponsoring clinical trial NCT00597402?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00597402 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00597402's enrollment target sits among peer trials
125 39th of 199 higher than 160 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma 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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