Sequential and Concurrent FOLFOXIRI/Bevacizumab Regimens Versus FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer
Public ClinicalTrials.gov record NCT01765582. 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
Steam (Sequencing Triplet With Avastin and Maintenance): FOLFOXIRI/Bevacizumab Regimens (Concurrent and Sequential) vs. FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This randomized, open-label, multicenter study will evaluate the efficacy and safety of folinic acid (leucovorin), 5-fluorouracil (5-FU), oxaliplatin, and irinotecan (FOLFOXIRI) / bevacizumab regimens (concurrent and sequential) versus folinic acid (leucovorin), 5-fluorouracil, and oxaliplatin (FOLFOX) / bevacizumab in first-line in participants with metastatic colorectal cancer. Participants will be randomized to receive bevacizumab 5 milligrams per kilogram (mg/kg) intravenously every 2 weeks with either concurrent or sequential FOLFOXIRI or with FOLFOX for 4 to 6 months of induction therapy, followed by maintenance therapy with bevacizumab plus either leucovorin/5-fluorouracil or capecitabine until disease progression occurs. After disease progression, participants will receive treatment with a fluoropyrimidine-based chemotherapy plus bevacizumab.
Study identification
- NCT ID
- NCT01765582
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 280 participants
Conditions and interventions
Conditions
Interventions
- 5-fluorouracil Drug
- bevacizumab Drug
- capecitabine Drug
- irinotecan Drug
- folinic acid Drug
- oxaliplatin Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- 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
- Jan 23, 2013 (Actual)
- Primary completion
- Mar 14, 2016 (Actual)
- Completion
- Mar 14, 2016 (Actual)
- Last update posted
- Sep 18, 2017
2013 – 2016
United States locations
- U.S. sites
- 45
- U.S. states
- 24
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Alabama; Mitchell Cancer Institute | Mobile | Alabama | 36604 | — |
| Long Beach Memorial Medical Center; Oncology | Long Beach | California | 90806 | — |
| LAC-USC Medical Center | Los Angeles | California | 90033 | — |
| USC Norris Cancer Center | Los Angeles | California | 90033 | — |
| Pacific Cancer Care - Monterey | Monterey | California | 93940 | — |
| Sacramento Center for Hematolo | Sacramento | California | 95816 | — |
| Pacific Cancer Care | Salinas | California | 93901 | — |
| Kaiser Permanente - Franklin | Denver | Colorado | 80205 | — |
| Yale Cancer Center | New Haven | Connecticut | 06520 | — |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | — |
| Florida Cancer Specialists - Fort Myers (Colonial Center Dr) | Fort Myers | Florida | 33905 | — |
| Florida Cancer Specialist, North Region | St. Petersburg | Florida | 33705 | — |
| University Cancer & Blood Center, LLC | Athens | Georgia | 30607 | — |
| Emory University Clinic | Atlanta | Georgia | 30322 | — |
| Central Georgia Cancer Care PC | Macon | Georgia | 31201 | — |
| Summit Cancer Care PC | Savannah | Georgia | 31405 | — |
| Ingalls Memorial Hosp | Harvey | Illinois | 60426 | — |
| Edward Cancer Center Naperville | Naperville | Illinois | 60540 | — |
| Edward Cancer Center Plainfield | Plainfield | Illinois | 60585 | — |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | — |
| Johns Hopkins Univ; Bunting Blaustein Cancer Center | Baltimore | Maryland | 21231 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| St. Joseph Mercy Hospital; Cancer Care Center. | Ann Arbor | Michigan | 48106 | — |
| Karmanos Cancer Institute.. | Detroit | Michigan | 48201 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Southeast Nebraska Cancer Center;; Southeast Nebraska Hematology and Oncology | Lincoln | Nebraska | 68510 | — |
| Nebraska Methodist Hospital; Cancer Center | Omaha | Nebraska | 68114 | — |
| Dartmouth Hitchcock Med Center | Lebanon | New Hampshire | 03756 | — |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45242 | — |
| University of Oklahoma; Stephenson Oklahoma Canc Ctr | Oklahoma City | Oklahoma | 73104 | — |
| Milton S. Hershey Medical Center; Penn State Cancer Inst. | Hershey | Pennsylvania | 17033 | — |
| Chattanooga Oncology and Hematology Associates, PC | Chattanooga | Tennessee | 37404 | — |
| West Clinic | Germantown | Tennessee | 38138 | — |
| Sarah Cannon Cancer Center and Research Institute | Nashville | Tennessee | 37203 | — |
| UT Southwestern MC at Dallas | Dallas | Texas | 75390-9063 | — |
| Ctr for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | — |
| Scott and White Hospital; Cancer Center | Temple | Texas | 76508 | — |
| Virginia Cancer Institute | Richmond | Virginia | 23226 | — |
| Seattle Cancer Care Alliance - Evergreen Health | Kirkland | Washington | 98034 | — |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | — |
| Medical Oncology Associates | Spokane | Washington | 99208 | — |
| Vince Lombardi Cancer Center | Green Bay | Wisconsin | 54311 | — |
| Medical College of Wisconsin; Dept Froedtert Clin Can Ctr | Milwaukee | Wisconsin | 53226 | — |
| Aurora Research Institute | Wauwatosa | Wisconsin | 53226 | — |
| Cheyenne Oncology & Hematology Associates | Cheyenne | Wyoming | 82001 | — |
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 NCT01765582, 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 Sep 18, 2017 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01765582 live on ClinicalTrials.gov.