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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 is a Phase 3 study that has completed, run by Sirtex Medical. The registered enrollment target is 209 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01721954
The ClinicalTrials.gov registry entry for NCT01721954 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 209 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sirtex Medical, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which FOLFOX6m is the first listed.
NCT01721954 reports 0 study locations.
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.
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