FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer (SIRFLOX)

Sirtex Medical

Status: Completed

Conditions: Colorectal Carcinoma; Liver Metastases; Colorectal Cancer

Treatments: Device: SIR-Spheres yttrium-90 microspheres; Drug: Systemic chemotherapy (FOLFOX)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00724503

STX0206

Details and patient eligibility

About

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.

Enrollment: 530 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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).
• Suitable for either treatment regimen.
• Prior chemotherapy for metastatic colorectal cancer is not allowed.
• WHO performance status 0-1.
• Adequate hematological, renal and hepatic function.
• Age 18 years or older.
• Willing and able to provide written informed consent.
• Life expectancy of at least 3 months without any active treatment.

Exclusion Criteria

• Evidence of ascites, cirrhosis, portal hypertension, main portal or venous tumor involvement or thrombosis as determined by clinical or radiologic assessment.
• Previous radiotherapy delivered to the upper abdomen.
• Non-malignant disease that would render the patient unsuitable for treatment according to the protocol.
• Peripheral neuropathy > grade 1 (NCI-CTC).
• Dose limiting toxicity with previous adjuvant 5-FU or oxaliplatin chemotherapy.
• Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is not an exclusion criteria provided that it was completed more than 6 months before entry into the study.
• Pregnant or breast-feeding.
• Other active malignancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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530 participants in 2 patient groups

mFOLFOX6 + SIRT

Experimental group

Description:

A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)

Treatment:

Device: SIR-Spheres yttrium-90 microspheres

mFOLFOX6

Active Comparator group

Description:

Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5- Fluorouracil (FOLFOX).

Treatment:

Drug: Systemic chemotherapy (FOLFOX)