A Study With Neoadjuvant mFOLFOX7 Plus Cetuximab to Determine the Surgical Conversion Rate for Unresectable Colorectal Cancer With Metastases Confined to the Liver
Public ClinicalTrials.gov record NCT00803647. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Study to Determine the Surgical Conversion Rate in Patients Receiving Neoadjuvant mFOLFOX7 + Cetuximab for Unresectable Wild-Type K-RAS Colorectal Cancer With Metastases Confined to the Liver
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00803647
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 20 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2009
- Primary completion
- Jun 30, 2013
- Completion
- Oct 31, 2014
- Last update posted
- Oct 5, 2021
2010 – 2014
United States locations
- U.S. sites
- 23
- U.S. states
- 14
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Loma Linda University Medical Center | Loma Linda | California | 92354 | — |
| St. Joseph Hospital | Orange | California | 92868 | — |
| Kaiser Permanente-San Diego | San Diego | California | 92120 | — |
| Kaiser Permanente Medical Center - Vallejo | Vallejo | California | 94589 | — |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19718 | — |
| M.D. Anderson Cancer Center - Orlando | Orlando | Florida | 32806 | — |
| CCOP - NorthShore University HealthSystem | Evanston | Illinois | 60201 | — |
| Edward Hospital | Naperville | Illinois | 60566 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| NortonHealthcare, Inc. | Louisville | Kentucky | 40202-5070 | — |
| Franklin Square Hospital Center | Baltimore | Maryland | 21237 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| CCOP - Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan | 49503 | — |
| CCOP, William Beaumont Hospital | Royal Oak | Michigan | 48073 | — |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | — |
| CCOP, Dayton, OH | Dayton | Ohio | 45420 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| NSABP Foundation, Inc. | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15232-1305 | — |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | — |
| Vermont Cancer Center at University of Vermont | Burlington | Vermont | 05405-0075 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00803647, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 5, 2021 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00803647 live on ClinicalTrials.gov.