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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: Clinical Trial Phase 1 study, sponsored by University of Wisconsin, Madison.
NCT01128387 is a Phase 1 study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Maximum Tolerated Dose (MTD) will be where 0 of 6 patients experienced Dose Limiting Toxicities (DLT) from start until 28 days after the completion of radiation. The investigator considered DLTs related to the treatment to be: grade 4 hematologic toxicity, grade 3 hematologic toxicity lasting \>7 days, any neutropenic fever, all grade 3 non-hematologic toxicities (excluding alopecia and nausea/vomiting/diarrhea if controlled with antiemetics or anti-diarrheal agents), grade 4 lab abnormality (wh
Interventions
- DRUG Panitumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2010-05 |
| Est. Completion | 2016-10 |
| Phase | Phase 1 |
Why NCT01128387 stopped before completion
NCT01128387 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Panitumumab is the first listed.
NCT01128387 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01128387's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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