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NCT00580073 · ClinicalTrials.gov registry record · Phase 2
Phase II Trial of Neoadjuvant FOLFOX4 and Cetuximab for Localized Adenocarcinoma of Rectum
A Phase 2 study, sponsored by University of Wisconsin, Madison.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT00580073: Clinical Trial Phase 2 study, sponsored by University of Wisconsin, Madison.
NCT00580073 is a Phase 2 study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00580073, a Phase 2 study, was terminated before completion, sponsored by University of Wisconsin, Madison.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
This study involves the use of Oxaliplatin, 5-Fluorouracil (5-FU), Leucovorin and Cetuximab, which are all medicines approved by the Food and Drug Administration (FDA) and are commercially available. This treatment regimen will possibly be combined with radiation before and/or after surgery depending on your response to the treatment. Their use in this exact combination is considered experimental. The purpose of this study is to find out how effective this combination of chemotherapy is as treatment for rectal cancer that has not spread to other parts of the body. The side effects and survival experienced by subjects receiving these drugs will also be evaluated. This is a phase II research study.
Primary Outcome
Down-staging of the tumor and tumor response rate is defined as the proportion of participant who have any evidence of complete response (CR), pathologic complete response (pCR), or partial response (PR).
Interventions
- DRUG Cetuximab
- DRUG FOLFOX4
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2007-12 |
| Est. Completion | 2009-11 |
| Phase | Phase 2 |
Why NCT00580073 stopped before completion
NCT00580073 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Cetuximab is the first listed.
NCT00580073 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00580073 about?
NCT00580073 is a clinical study titled "Phase II Trial of Neoadjuvant FOLFOX4 and Cetuximab for Localized Adenocarcinoma of Rectum". This study involves the use of Oxaliplatin, 5-Fluorouracil (5-FU), Leucovorin and Cetuximab, which are all medicines approved by the Food and Drug Administration (FDA) and are commercially available. This treatment regimen will possibly be combined with radiation before and/or after surgery dependin...
What is the current status of trial NCT00580073?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2007-12. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00580073?
The interventions under investigation include: Cetuximab (DRUG), FOLFOX4 (DRUG).
Who is sponsoring clinical trial NCT00580073?
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 NCT00580073's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 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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