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NCT01128387 · ClinicalTrials.gov registry record · Phase 1
Trial of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation in Esophageal Cancer
A Phase 1 study, sponsored by University of Wisconsin, Madison.
- Terminated
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT01128387 is a Phase 1 study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 11 participants.
The verdict
NCT01128387, a Phase 1 study, was terminated before completion, sponsored by University of Wisconsin, Madison.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
The overall study objective is to evaluate the dose limiting toxicities and the recommended phase II dose of Panitumumab when combined with the standard of care treatment with cisplatin, fluorouracil and radiation in patients with locally advanced esophageal cancer. The investigators will also be assessing the ability of PET (Positron Emission Tomography) imaging to predict the degree of pathologic response. All patients will have a pre-study FDG (F-18 Fluorodeoxyglucose) PET scan and will receive radiation therapy and chemotherapy over a 35 day period. 4-8 weeks post radiation and chemotherapy patients will be restaged with a PET/CT scan. It is anticipated that approximately 30 patients enrolled will undergo an esophagectomy which is considered standard of care post radiation and chemotherapy. The surgery will allow us to compare this study regimen to the historical standard of care (Cisplatin/fluorouracil chemotherapy with radiation therapy).
Interventions
- DRUG Panitumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2010-05 |
| Est. Completion | 2016-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01128387
The ClinicalTrials.gov registry entry for NCT01128387 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Panitumumab is the first listed.
NCT01128387 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01128387 about?
NCT01128387 is a clinical study titled "Trial of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation in Esophageal Cancer". The overall study objective is to evaluate the dose limiting toxicities and the recommended phase II dose of Panitumumab when combined with the standard of care treatment with cisplatin, fluorouracil and radiation in patients with locally advanced esophageal cancer. The investigators will also be as...
What is the current status of trial NCT01128387?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2010-05. Estimated completion is 2016-10.
What interventions are being tested in trial NCT01128387?
The interventions under investigation include: Panitumumab (DRUG).
Who is sponsoring clinical trial NCT01128387?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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