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NCT00724503 · ClinicalTrials.gov registry record · NA
FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer
A NA study, sponsored by Sirtex Medical.
- Completed
- Registry status
- NA
- Development phase
- 530
- Enrollment target
NCT00724503: Completed NA study, sponsored by Sirtex Medical.
NCT00724503 is a NA study that has completed, run by Sirtex Medical. The registered enrollment target is 530 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00724503, a NA study, has completed, sponsored by Sirtex Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 530 participants
- Enrollment target
Study Summary
This study is a randomized multi-center trial that will assess the effect of adding Selective Internal Radiation Therapy (SIRT), using SIR-Spheres microspheres®, to a standard chemotherapy regimen of FOLFOX as first line therapy in patients with non-resectable liver metastases from primary colorectal adenocarcinoma. 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 treating Investigator.
Primary Outcome
PFS defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as an increase in the sum of the longest diameters of ≥ 20% and an absolute increase in the sum of the longest diameters of ≥ 5 mm, or the appearance of a new lesion.
Interventions
- DEVICE SIR-Spheres yttrium-90 microspheres
- DRUG Systemic chemotherapy (FOLFOX)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 530 participants |
| Start Date | 2006-08 |
| Est. Completion | 2015-05 |
| Phase | NA |
What the finished NCT00724503 record still lists
NCT00724503 is an interventional study that assigns participants to a tested intervention. The registered 530 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which SIR-Spheres yttrium-90 microspheres is the first listed.
NCT00724503 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00724503 about?
NCT00724503 is a clinical study titled "FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer". This study is a randomized multi-center trial that will assess the effect of adding Selective Internal Radiation Therapy (SIRT), using SIR-Spheres microspheres®, to a standard chemotherapy regimen of FOLFOX as first line therapy in patients with non-resectable liver metastases from primary colorecta...
What is the current status of trial NCT00724503?
This trial is currently completed. It is a NA study. The enrollment target is 530 participants. The study started on 2006-08. Estimated completion is 2015-05.
What interventions are being tested in trial NCT00724503?
The interventions under investigation include: SIR-Spheres yttrium-90 microspheres (DEVICE), Systemic chemotherapy (FOLFOX) (DRUG).
Who is sponsoring clinical trial NCT00724503?
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 NCT00724503's enrollment target sits among peer trials
530 188th of 2000 higher than 1,813 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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