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NCT01769508 · ClinicalTrials.gov registry record · Phase 2
Study of 5-FU, Oxaliplatin, & Lapatinib Combined With Radiation Therapy to Treat HER2 Positive Esophagogastric Cancer
A Phase 2 study, sponsored by SCRI Development Innovations.
- Terminated
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT01769508: Clinical Trial Phase 2 study, sponsored by SCRI Development Innovations.
NCT01769508 is a Phase 2 study that was terminated before completion, run by SCRI Development Innovations. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01769508, a Phase 2 study, was terminated before completion, sponsored by SCRI Development Innovations.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
With improvements in response rate and survival seen for HER2 positive patients treated with HER2 blockade in the metastatic setting, the use of HER2 blockade in the neoadjuvant setting to increase antitumor effect shows promise. Patients with previously untreated localized HER2 positive esophageal, GE junction and gastric adenocarcinomas will be enrolled. Patients meeting all inclusion/exclusion criteria will receive neoadjuvant treatment with concurrent chemotherapy and radiation therapy beginning on day 1 of treatment. During the lead-in safety portion, the optimal dose of lapatinib will be determined.
Primary Outcome
Defined as the absence of invasive tumor in esophagogastric and lymph node tissue removed at time of surgery, as judged by the local pathologist. An improvement in pCR rate from 30 percent (historical) to 50 percent is the primary efficacy endpoint.
Interventions
- DRUG Oxaliplatin
- RADIATION Radiation Therapy
- DRUG 5-Fluorouracil
- DRUG Lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-02 |
| Est. Completion | 2015-02 |
| Phase | Phase 2 |
Why NCT01769508 stopped before completion
NCT01769508 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 4 interventions - of which Oxaliplatin is the first listed.
NCT01769508 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01769508 about?
NCT01769508 is a clinical study titled "Study of 5-FU, Oxaliplatin, & Lapatinib Combined With Radiation Therapy to Treat HER2 Positive Esophagogastric Cancer". With improvements in response rate and survival seen for HER2 positive patients treated with HER2 blockade in the metastatic setting, the use of HER2 blockade in the neoadjuvant setting to increase antitumor effect shows promise. Patients with previously untreated localized HER2 positive esophageal,...
What is the current status of trial NCT01769508?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2013-02. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01769508?
The interventions under investigation include: Oxaliplatin (DRUG), Radiation Therapy (RADIATION), 5-Fluorouracil (DRUG), Lapatinib (DRUG).
Who is sponsoring clinical trial NCT01769508?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01769508's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 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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