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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 is a Phase 2 study that was terminated before completion, run by SCRI Development Innovations. The registered enrollment target is 12 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01769508
The ClinicalTrials.gov registry entry for NCT01769508 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SCRI Development Innovations, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Oxaliplatin is the first listed.
NCT01769508 reports 0 study locations.
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.
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