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NCT00857246 · ClinicalTrials.gov registry record · Phase 2
Pre-operation Chemo and Antibody Therapy Followed by Surgical Resection and Adjuvant Chemoradiation for Gastric Cancer
A Phase 2 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00857246: Completed Phase 2 study, sponsored by NYU Langone Health.
NCT00857246 is a Phase 2 study that has completed, run by NYU Langone Health. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00857246, a Phase 2 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study intends to evaluate the feasibility and treatment efficacy of adding an antibody blocking the epidermal growth factor (EGF) pathway to a neoadjuvant approach with proven efficacy developed at New York University.
Primary Outcome
Clinical response rate is defined as the percentage of patients who responded to the induction regimen. The response is determined based on endoscopic ultrasonography (EUS) staging pre-treatment and post-treatment, CT scans pre- and post- operatively, and initial clinical stage (based on these tests) compared with the pathologic stage. Any "down-staging" of T or N stage is considered to be a result of induction therapy and counted as a clinical response.
Interventions
- DRUG Cisplatin
- DRUG Cetuximab
- DRUG Irinotecan
- PROCEDURE Surgery
- DRUG 5-FU
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2005-07 |
| Est. Completion | 2015-10 |
| Phase | Phase 2 |
What the finished NCT00857246 record still lists
NCT00857246 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT00857246 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00857246 about?
NCT00857246 is a clinical study titled "Pre-operation Chemo and Antibody Therapy Followed by Surgical Resection and Adjuvant Chemoradiation for Gastric Cancer". This study intends to evaluate the feasibility and treatment efficacy of adding an antibody blocking the epidermal growth factor (EGF) pathway to a neoadjuvant approach with proven efficacy developed at New York University.
What is the current status of trial NCT00857246?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2005-07. Estimated completion is 2015-10.
What interventions are being tested in trial NCT00857246?
The interventions under investigation include: Cisplatin (DRUG), Cetuximab (DRUG), Irinotecan (DRUG), Surgery (PROCEDURE), 5-FU (DRUG).
Who is sponsoring clinical trial NCT00857246?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00857246's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 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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