FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer (FOXFIREGlobal)
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|ClinicalTrials.gov Identifier: NCT01721954|
Recruitment Status : Completed
First Posted : November 6, 2012
Results First Posted : October 22, 2019
Last Update Posted : November 5, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic||Drug: FOLFOX6m Device: SIR-Spheres microspheres||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||209 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of Overall Survival of FOLFOX6m Plus SIR-Spheres Microspheres Versus FOLFOX6m Alone as First-line Treatment in Patients With Non-resectable Liver Metastases From Primary Colorectal Carcinoma in a Randomised Clinical Study|
|Actual Study Start Date :||May 1, 2013|
|Actual Primary Completion Date :||December 23, 2016|
|Actual Study Completion Date :||February 28, 2017|
Active Comparator: Control Arm
Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.
Experimental: Experimental Arm
Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.
Device: SIR-Spheres microspheres
- Overall Survival (OS) [ Time Frame: From date of randomization until the date of death from any cause assessed up 3 yrs 8 months ]OS defined as the time interval between the date of randomization and the date of death from any cause.
- Progression-free Survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years 8 months. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721954