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NCT00515216 · ClinicalTrials.gov registry record · Phase 2
Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal Junction (GEJ) Tumors
A Phase 2 study, sponsored by Vanderbilt University.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT00515216: Completed Phase 2 study, sponsored by Vanderbilt University.
NCT00515216 is a Phase 2 study that has completed, run by Vanderbilt University. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00515216, a Phase 2 study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
This study is for patients who have stomach cancer or cancer of the lower part of the esophagus that has spread to other organs. There are many different chemotherapy treatments for this type of cancer. At the present time, there is no general agreement on the way to choose the most beneficial therapy for an individual patient. Patients with different genetic backgrounds may respond differently to the same chemotherapy treatments. In this study the investigators will use a certain genetic difference in an important gene (thymidylate synthase or TS gene) to see whether treating patients who have a particular type of that gene will respond better to a standard chemotherapy regimen. The investigators are hoping that by treating patients according to their genes, that they may respond to treatment of their cancer better and it will help the investigators choose cancer treatments better in the future.
Primary Outcome
* ORR = complete response + partial response * Complete response - disappearance of all target and non-target lesions * Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter
Interventions
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG 5-fluorouracil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2007-08 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
What the finished NCT00515216 record still lists
NCT00515216 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 3 interventions - of which Leucovorin is the first listed.
NCT00515216 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00515216 about?
NCT00515216 is a clinical study titled "Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal Junction (GEJ) Tumors". This study is for patients who have stomach cancer or cancer of the lower part of the esophagus that has spread to other organs. There are many different chemotherapy treatments for this type of cancer. At the present time, there is no general agreement on the way to choose the most beneficial thera...
What is the current status of trial NCT00515216?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2007-08. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00515216?
The interventions under investigation include: Leucovorin (DRUG), Oxaliplatin (DRUG), 5-fluorouracil (DRUG).
Who is sponsoring clinical trial NCT00515216?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00515216's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 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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