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NCT01747551 · ClinicalTrials.gov registry record · Phase 2
FOLFOX +/- Ziv-Aflibercept for Esophageal and Gastric Cancer
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
NCT01747551 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 64 participants.
The verdict
NCT01747551, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
Study Summary
Anti-angiogenic therapy is a proven therapeutic target in refractory gastric and gastroesophageal junction adenocarcinoma. This trial assessed whether the addition of a high affinity angiogenesis inhibitor, ziv-aflibercept, could improve the efficacy of first-line mFOLFOX6 (oxaliplatin, leucovorin, and bolus plus infusional 5- fluorouracil) chemotherapy in metastatic esophagogastric adenocarcinoma. In this study (ZAMEGA), patients with treatment-naïve esophagogastric adenocarcinoma were randomly assigned 2:1 in a multicenter, placebo-controlled double-blind trial to receive first-line mFOLFOX6 with or without ziv-aflibercept 4mg/kg every 2 weeks. Randomization was stratified by ECOG performance status (0-1 vs. 2) and primary site of disease (esophagus or GE junction vs stomach).
Interventions
- DRUG Fluorouracil
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG Ziv-aflibercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2013-01 |
| Est. Completion | 2017-07-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01747551
The ClinicalTrials.gov registry entry for NCT01747551 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Fluorouracil is the first listed.
NCT01747551 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01747551 about?
NCT01747551 is a clinical study titled "FOLFOX +/- Ziv-Aflibercept for Esophageal and Gastric Cancer". Anti-angiogenic therapy is a proven therapeutic target in refractory gastric and gastroesophageal junction adenocarcinoma. This trial assessed whether the addition of a high affinity angiogenesis inhibitor, ziv-aflibercept, could improve the efficacy of first-line mFOLFOX6 (oxaliplatin, leucovorin, ...
What is the current status of trial NCT01747551?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2013-01. Estimated completion is 2017-07-26.
What interventions are being tested in trial NCT01747551?
The interventions under investigation include: Fluorouracil (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), Ziv-aflibercept (DRUG).
Who is sponsoring clinical trial NCT01747551?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
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