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NCT00803647 · ClinicalTrials.gov registry record · Phase 2
A Study With Neoadjuvant mFOLFOX7 Plus Cetuximab to Determine the Surgical Conversion Rate for Unresectable Colorectal Cancer With Metastases Confined to the Liver
A Phase 2 study, sponsored by NSABP Foundation.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT00803647 is a Phase 2 study that has completed, run by NSABP Foundation. The registered enrollment target is 20 participants.
The verdict
NCT00803647, a Phase 2 study, has completed, sponsored by NSABP Foundation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
FC-6 is a Phase II, multi-center clinical trial for patients with unresectable, wild-type K-RAS, colorectal cancer with metastases confined to the liver. Liver metastases must be determined by FC-6 criteria to be unresectable, and the colorectal cancer (CRC) tumor (primary or metastatic) must be found to be wild-type K-RAS. Patients with mutant K-RAS tumors are ineligible. K-RAS testing can be done through the local hospital or a tumor sample can be submitted to the FC-6 central lab (Esoterix Clinical Trial Services). A primary aim of this study is to evaluate the surgical conversion rate using cytotoxic combination chemotherapy and biologic therapy with cetuximab, a monoclonal antibody targeted against the epidermal growth factor receptor. A second primary aim is to evaluate the safety and tolerability of a chemotherapy/targeted therapy regimen in this patient population. Secondary aims include determination of clinical response rate, recurrence-free survival for patients undergoing complete resection and/or ablation of liver metastases, and overall survival.
Interventions
- DRUG 5-FU
- DRUG oxaliplatin
- BIOLOGICAL cetuximab
- DRUG leucovorin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-01 |
| Est. Completion | 2014-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00803647
The ClinicalTrials.gov registry entry for NCT00803647 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NSABP Foundation, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which 5-FU is the first listed.
NCT00803647 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00803647 about?
NCT00803647 is a clinical study titled "A Study With Neoadjuvant mFOLFOX7 Plus Cetuximab to Determine the Surgical Conversion Rate for Unresectable Colorectal Cancer With Metastases Confined to the Liver". FC-6 is a Phase II, multi-center clinical trial for patients with unresectable, wild-type K-RAS, colorectal cancer with metastases confined to the liver. Liver metastases must be determined by FC-6 criteria to be unresectable, and the colorectal cancer (CRC) tumor (primary or metastatic) must be fou...
What is the current status of trial NCT00803647?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2010-01. Estimated completion is 2014-11.
What interventions are being tested in trial NCT00803647?
The interventions under investigation include: 5-FU (DRUG), oxaliplatin (DRUG), cetuximab (BIOLOGICAL), leucovorin (DRUG).
Who is sponsoring clinical trial NCT00803647?
This trial is sponsored by NSABP Foundation, which has 44 total clinical trials registered on ClinicalTrials.gov.
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