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NCT01721954 · ClinicalTrials.gov registry record · Phase 3
FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer
A Phase 3 study, sponsored by Sirtex Medical.
- Completed
- Registry status
- Phase 3
- Development phase
- 209
- Enrollment target
NCT01721954: Completed Phase 3 study, sponsored by Sirtex Medical.
NCT01721954 is a Phase 3 study that has completed, run by Sirtex Medical. The registered enrollment target is 209 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01721954, a Phase 3 study, has completed, sponsored by Sirtex Medical.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 209 participants
- Enrollment target
Study Summary
This study is a randomized, multi-center study that will compare the efficacy and safety of selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with non-resectable liver metastases from primary colorectal carcinoma. Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the Investigator.
Primary Outcome
OS defined as the time interval between the date of randomization and the date of death from any cause.
Interventions
- DRUG FOLFOX6m
- DEVICE SIR-Spheres microspheres
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 209 participants |
| Start Date | 2013-05-01 |
| Est. Completion | 2017-02-28 |
| Phase | Phase 3 |
What the finished NCT01721954 record still lists
NCT01721954 is an interventional study that assigns participants to a tested intervention. The registered 209 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which FOLFOX6m is the first listed.
NCT01721954 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01721954 about?
NCT01721954 is a clinical study titled "FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer". This study is a randomized, multi-center study that will compare the efficacy and safety of selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with non-resectable liver me...
What is the current status of trial NCT01721954?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 209 participants. The study started on 2013-05-01. Estimated completion is 2017-02-28.
What interventions are being tested in trial NCT01721954?
The interventions under investigation include: FOLFOX6m (DRUG), SIR-Spheres microspheres (DEVICE).
Who is sponsoring clinical trial NCT01721954?
This trial is sponsored by Sirtex Medical, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01721954's enrollment target sits among peer trials
209 1345th of 2000 higher than 656 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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