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NCT01765582 · ClinicalTrials.gov registry record · Phase 2
Sequential and Concurrent FOLFOXIRI/Bevacizumab Regimens Versus FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 2
- Development phase
- 280
- Enrollment target
NCT01765582: Clinical Trial Phase 2 study, sponsored by Hoffmann-La Roche.
NCT01765582 is a Phase 2 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 280 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (111% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01765582, a Phase 2 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 280 participants
- Enrollment target
Study Summary
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.
Primary Outcome
ORR1 was the percentage of participants with complete response (CR) or partial response (PR) during first-line therapy as assessed by investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v.1.1). CR was defined as disappearance of all extranodal target lesions and all pathological lymph nodes had to have decreased to \<10 millimeter (mm) in short axis. PR was defined as at least a 30% decrease in the sum of longest diameters of target lesions, taking as refer
Interventions
- DRUG 5-fluorouracil
- DRUG bevacizumab
- DRUG capecitabine
- DRUG folinic acid
- DRUG irinotecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2013-01-23 |
| Est. Completion | 2016-03-14 |
| Phase | Phase 2 |
Why NCT01765582 stopped before completion
NCT01765582 is an interventional study that assigns participants to a tested intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (111% higher).
The record links to 0 conditions, and to 5 interventions - of which 5-fluorouracil is the first listed.
NCT01765582 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01765582 about?
NCT01765582 is a clinical study titled "Sequential and Concurrent FOLFOXIRI/Bevacizumab Regimens Versus FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer". 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 (FOLF...
What is the current status of trial NCT01765582?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 280 participants. The study started on 2013-01-23. Estimated completion is 2016-03-14.
What interventions are being tested in trial NCT01765582?
The interventions under investigation include: 5-fluorouracil (DRUG), bevacizumab (DRUG), capecitabine (DRUG), folinic acid (DRUG), irinotecan (DRUG).
Who is sponsoring clinical trial NCT01765582?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01765582's enrollment target sits among peer trials
280 196th of 2000 higher than 1,800 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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