For further information on these on-going clinical studies, please see the Clinical Investigation Program flyer or go to http://clinicaltrials.gov/

Liver Metastases

TitleSettingSponsorStudy IDTreatment Arm(s)Location
SIRFLOX
www.sirflox.com
FOLFOX + SIR-Spheres microspheres versus FOLFOX alone in patients with liver metastases from primary colorectal cancer
1st-line Colorectal Cancer SIRTEX NCT00724503 FOLFOX (± bevacizumab) versus FOLFOX (± bevacizumab) + SIR-Spheres microspheres Global
FOXFIRE
www.octo-oxford.org.uk/alltrials/trials/FOXFIRE
www.controlled-trials.com/isrctn/pf/83867919
An open-label randomised phase III trial of 5-fluorouracil, oxaliplatin and folinic acid with or without interventional radioembolisation as first-line treatment for patients with unresectable liver-only or liver-predominant metastatic colorectal cancer
1st-line Colorectal Cancer Collaborative Group Study ISRCTN83867919 OxMdG (FOLFOX) (± biologic agent) versus OxMdG (± biologic agent) + SIR-Spheres microspheres UK
FOXFIRE Global
http://foxfireglobal.sirtex.com/  FOLFOX6m + SIR Spheres microspheres versus FOLFOX6m alone in patients with liver metastases from primary colorectal cancer
1st-line Colorectal Cancer SIRTEX NCT01721954 FOLFOX (± bevacizumab) versus FOLFOX (± bevacizumab) + SIR Spheres microspheres Global
SIR-step
A randomised phase III study comparing hepatic arterial injection of Yttrium-90 resin microspheres (SIR-Spheres microspheres) plus systemic maintenance therapy versus systemic maintenance therapy alone for patients with unresectable liver metastases from colorectal cancer which are controlled after induction systemic therapy
1st-line Colorectal Cancer Collaborative Group Study NCT01895257 1st-line chemotherapy (3 months) followed by: 5FU/LV (± bevacizumab) versus 1st-line chemotherapy (3 months) followed by 5FU/LV (± bevacizumab) + SIR-Spheres microspheres Europe
SIRUM
SIR-Spheres microspheres treatment of uveal melanoma metastasized to liver
Uveal Melanoma Investigator-Initiated Research Study NCT01473004 SIR-Spheres microspheres USA
Sorafenib and radioembolization with SIR Spheres® for the treatment of metastatic ocular melanoma Uveal Melanoma Investigator-Initiated Research Study NCT01893099 SIR Spheres microspheres > sorafenib or sorafenib > SIR Spheres microspheres Switzerland
SIRMITOC Breast Cancer Investigator-Initiated Research Study   SIR Spheres microspheres > mitomycin C Belgium
A Two Arm Safety Study of Regorafenib before or after SIR-Spheres® Microspheres (90Y) for the Treatment of Patients with Refractory Metastatic Colorectal Cancer and Liver Metastases Refractory metastatic colorectal cancer Investigator Initiated NCT02195011 regorafenib > SIR-Spheres microspheres > regorafenib versus SIR-Spheres microspheres > regorafenib USA

Primary Liver Cancer

TitleSettingSponsorStudy IDTreatment Arm(s)Location
SIRveNIB
http://www.sirvenib.com/
Study to compare selective internal radiation therapy (SIRT) versus sorafenib in locally advanced hepatocellular carcinoma
Hepatocellular Carcinoma Collaborative Group Study NCT01135056 Sorafenib versus SIR-Spheres microspheres Asia-Pacific
SARAH
Sorafenib versus radioembolization in advanced hepatocellular carcinoma
Hepatocellular Carcinoma Collaborative Group Study NCT01482442 Sorafenib versus SIR-Spheres microspheres France
SORAMIC
www.soramic.de Sorafenib and micro-therapy guided by primovist-enhanced MRI in patients with inoperable liver cancer
Hepatocellular Carcinoma Investigator-Initiated Research Study NCT01126645 Sorafenib versus SIR-Spheres microspheres > Sorafenib Europe
TRYPHON
Y90 radioembolization prior to surgical resection or radiofrequency for hepatocellular carcinoma in cirrhotic liver
Hepatocellular Carcinoma Investigator-Initiated Research Study NCT01686880 SIR Spheres microspheres Belgium
Selective internal radiation therapy (SIRT) versus transarterial chemoembolisation (TACE) for the treatment of cholangiocellular carcinoma (CCC) Intra-Hepatic Cholangiocarcinoma Investigator-Initiated Research Study NCT01798147 SIR Spheres microspheres versus transarterial chemoembolisation (TACE) Germany

Primary Renal Cell Carcinoma

TitleSettingSponsorStudy IDTreatment Arm(s)Location
RESIRT
Pilot study of selective internal radiation therapy (SIRT) with yttrium-90 resin microspheres (SIR-Spheres microspheres) in patients with renal cell carcinoma
Renal Cell Carcinoma SIRTEX ACTRN 12610000690055 SIR-Spheres microspheres Australia


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