Regorafenib+FOLFIRI Versus Placebo+FOLFIRI as 2nd Line Tx in Metastatic Colorectal Cancer
Public ClinicalTrials.gov record NCT01298570. 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
Multi-Center, Randomized, Placebo-Controlled Phase II Study of Regorafenib in Combination With FOLFIRI Versus Placebo With FOLFIRI as Second-Line Therapy in Patients With Metastatic Colorectal Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This randomized (2:1), multi-center, placebo-controlled, phase II efficacy study is designed to compare PFS between regorafenib + FOLFIRI chemotherapy (ARM A) versus placebo + FOLFIRI (ARM B) in patients with mCRC previously treated with a FOLFOX regimen.
Study identification
- NCT ID
- NCT01298570
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 181 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
- Apr 7, 2011 (Actual)
- Primary completion
- Nov 15, 2016 (Actual)
- Completion
- Oct 2, 2020 (Actual)
- Last update posted
- Jan 6, 2021
2011 – 2020
United States locations
- U.S. sites
- 23
- U.S. states
- 10
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | — |
| Mount Sinai Medical Center-Miami | Miami | Florida | 33140 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Georgia Cancer Specialists | Atlanta | Georgia | 30341 | — |
| Indiana University Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| University of Louisville James Brown Cancer Center | Louisville | Kentucky | 40202 | — |
| North Shore Long Island Jewish Health System | Manhasset | New York | 11030 | — |
| New York University Langone Medical Center | New York | New York | 10016 | — |
| Seby B. Jones Cancer Center | Boone | North Carolina | 28607 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| Carolinas HealthCare System | Charlotte | North Carolina | 28262 | — |
| Southeast Medical Oncology Center | Goldsboro | North Carolina | 27534 | — |
| The Moses Cone Regional Cancer Center | Greensboro | North Carolina | 27403 | — |
| Leo W. Jenkins Cancer Center at ECU Medical School | Greenville | North Carolina | 27834 | — |
| First Health of the Carolinas, Moore Regional Hospital | Pinehurst | North Carolina | 28374 | — |
| Rex Cancer Center at Rex Hospital | Raleigh | North Carolina | 27607 | — |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43221 | — |
| University of Virginia | Charlottesville | Virginia | 22903 | — |
| Portsmouth Naval Medical Center | Portsmouth | Virginia | 23708 | — |
| Multicare Regional Cancer Center | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01298570, 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 Jan 6, 2021 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01298570 live on ClinicalTrials.gov.