Study Comparing Optimized 5-FU Dosing and Standard Dosing in Metastatic Colorectal Cancer Patients Treated With mFOLFOX6
Public ClinicalTrials.gov record NCT01468623. 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 Prospective, Randomized, Open-label Trial Comparing OnDose® AUC Optimized 5-FU Based Administration Versus Standard Body Surface Area (BSA) Dosing in Metastatic Colorectal Cancer Patients (mCRC) Treated With mFOLFOX6
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to compare OnDose® based pharmacokinetic administration of 5-FU versus standard Body Surface Area (BSA) based administration of 5-FU in patients with metastatic colorectal cancer treated with mFOLFOX6, with or without bevacizumab, to determine if the use of OnDose® achieves an improvement in the Overall Response Rate (ORR) relative to BSA dosing response.
Study identification
- NCT ID
- NCT01468623
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 51 participants
Conditions and interventions
Conditions
Interventions
Other
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
- Sep 2011 (Type not available)
- Primary completion
- Aug 2012 (Actual)
- Completion
- Aug 2012 (Actual)
- Last update posted
- Jul 19, 2023
2011 – 2012
United States locations
- U.S. sites
- 58
- U.S. states
- 24
- U.S. cities
- 58
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Corona | California | — | — |
| Not listed | Fountain Valley | California | — | — |
| Not listed | La Jolla | California | — | — |
| Not listed | Modesto | California | — | — |
| Not listed | Rancho Cucamonga | California | — | — |
| Not listed | Riverside | California | — | — |
| Not listed | Santa Rosa | California | — | — |
| Not listed | Washington D.C. | District of Columbia | — | — |
| Not listed | Merritt Island | Florida | — | — |
| Not listed | Ocala | Florida | — | — |
| Not listed | Titusville | Florida | — | — |
| Not listed | Viera | Florida | — | — |
| Not listed | Albany | Georgia | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Crystal Lake | Illinois | — | — |
| Not listed | Galesburg | Illinois | — | — |
| Not listed | Grayslake | Illinois | — | — |
| Not listed | Highland Park | Illinois | — | — |
| Not listed | Lake Forest | Illinois | — | — |
| Not listed | Libertyville | Illinois | — | — |
| Not listed | Niles | Illinois | — | — |
| Not listed | Skokie | Illinois | — | — |
| Not listed | Munster | Indiana | — | — |
| Not listed | Louisville | Kentucky | — | — |
| Not listed | Baton Rouge | Louisiana | — | — |
| Not listed | Metairie | Louisiana | — | — |
| Not listed | Ann Arbor | Michigan | — | — |
| Not listed | Detroit | Michigan | — | — |
| Not listed | Farmington Hills | Michigan | — | — |
| Not listed | Great Falls | Montana | — | — |
| Not listed | Las Vegas | Nevada | — | — |
| Not listed | Hackensack | New Jersey | — | — |
| Not listed | Johnson City | New York | — | — |
| Not listed | Greensboro | North Carolina | — | — |
| Not listed | Fargo | North Dakota | — | — |
| Not listed | Minot | North Dakota | — | — |
| Not listed | Canton | Ohio | — | — |
| Not listed | Columbus | Ohio | — | — |
| Not listed | Bend | Oregon | — | — |
| Not listed | Drexel Hill | Pennsylvania | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Crossville | Tennessee | — | — |
| Not listed | Huntsville | Tennessee | — | — |
| Not listed | Bedford | Texas | — | — |
| Not listed | Garland | Texas | — | — |
| Not listed | Grapevine | Texas | — | — |
| Not listed | Kerrville | Texas | — | — |
| Not listed | McAllen | Texas | — | — |
| Not listed | San Antonio | Texas | — | — |
| Not listed | Tyler | Texas | — | — |
| Not listed | Waco | Texas | — | — |
| Not listed | Ogden | Utah | — | — |
| Not listed | Salt Lake City | Utah | — | — |
| Not listed | Fairfax | Virginia | — | — |
| Not listed | Newport News | Virginia | — | — |
| Not listed | Edmonds | Washington | — | — |
| Not listed | Seattle | Washington | — | — |
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 NCT01468623, 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 Jul 19, 2023 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01468623 live on ClinicalTrials.gov.