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NCT00361231 · ClinicalTrials.gov registry record · Phase 2
Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Biliary Tract and Gallbladder Cancer
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT00361231: Completed Phase 2 study, sponsored by Massachusetts General Hospital.
NCT00361231 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00361231, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
The purposes of this study are to test the safety of bevacizumab when given in combination with gemcitabine and oxaliplatin and to see what effects (good and bad) this combination has on patients with cancer of bile duct or gallbladder. Bevacizumab has been shown to slow or stop cell growth in tumors by decreasing the blood supply to the tumors.
Primary Outcome
To assess the median progression free survival in patients with BTC on GEMOX-B. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition, death in the absence of radiological disease progression was also categorized as progression.
Interventions
- DRUG Bevacizumab
- DRUG Oxaliplatin
- DRUG Gemcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2006-05 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
What the finished NCT00361231 record still lists
NCT00361231 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 3 interventions - of which Bevacizumab is the first listed.
NCT00361231 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00361231 about?
NCT00361231 is a clinical study titled "Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Biliary Tract and Gallbladder Cancer". The purposes of this study are to test the safety of bevacizumab when given in combination with gemcitabine and oxaliplatin and to see what effects (good and bad) this combination has on patients with cancer of bile duct or gallbladder. Bevacizumab has been shown to slow or stop cell growth in tumor...
What is the current status of trial NCT00361231?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2006-05. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00361231?
The interventions under investigation include: Bevacizumab (DRUG), Oxaliplatin (DRUG), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT00361231?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00361231's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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