FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer (FOXFIREGlobal)

Sirtex Medical

Status and phase: Completed; Phase 3

Conditions: Colorectal Cancer Metastatic

Treatments: Drug: FOLFOX6m; Device: SIR-Spheres microspheres

Study type: Interventional

Funder types: Industry

Identifiers

NCT01721954

STX0112

Details and patient eligibility

About

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.

Enrollment: 209 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older
• Willing and able to provide written informed consent
• Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation
• Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (Lung: 5 lesions total, < 1 cm, or 1 single lesion of up to 1.7 cm; Lymph nodules in one single anatomic area (pelvis, abdomen or chest): any number, < 2 cm)
• All imaging evidence used as part of the screening process must be within 28 days
• Suitable for either treatment regimen
• WHO performance status 0-1
• Adequate hematological, renal and hepatic function
• Life expectancy of at least 3 months without any active treatment

Exclusion criteria

• Evidence of ascites, cirrhosis, portal hypertension, main portal or venous involvement or thrombosis as determined by clinical or radiologic assessment
• Previous radiotherapy delivered to the liver
• Non-malignant disease that would render the patient unsuitable for treatment according to the protocol
• Peripheral neuropathy > grade 2 (NCI-CTC)
• Dose-limiting toxicity associated with previous adjuvant 5-FU or oxaliplatin chemotherapy
• Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is permitted provided that it was completed more than 6 months before entry into the study
• Pregnant or breast feeding
• Concurrent or prior history of cancer other than adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
• Allergy to contrast media that would preclude angiography of the hepatic arteries

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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209 participants in 2 patient groups

Control Arm

Active Comparator group

Description:

Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.

Treatment:

Drug: FOLFOX6m

Experimental Arm

Experimental group

Description:

Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.

Treatment:

Device: SIR-Spheres microspheres

Drug: FOLFOX6m