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

Completed · Not applicable

Conditions studied: Colorectal Cancer, Colorectal Carcinoma, Liver Metastases

In brief

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.

Key facts

Study ID

NCT00724503

Run by

Sirtex Medical

People needed

530

Starts

2006-08-01

Expected to finish

2015-05-01

Last updated by the study team

2019-03-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• City of Hope Hospital — Duarte, California, United States
• Florida International University College of Medicine Practice — North Miami Beach, Florida, United States
• Vanguard Health — Berwyn, Illinois, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Adventist Hinsdale Hospital — Hinsdale, Illinois, United States
• University of Louisville — Louisville, Kentucky, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Virginia Piper Cancer Institute — Minneapolis, Minnesota, United States
• Holy Name Hospital — Teaneck, New Jersey, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Carolinas Hematology-Oncology Associates — Charlotte, North Carolina, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Altru Health Systems — Grand Forks, North Dakota, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• St. Mark's Hospital — Salt Lake City, Utah, United States
• University of Washington — Seattle, Washington, United States
• Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States
• Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital — Milwaukee, Wisconsin, United States
• Concord Hospital — Concord, New South Wales, Australia
• St. Vincent's Hospital — Darlinghurst, New South Wales, Australia
• Nepean Cancer Care Centre — Kingswood, New South Wales, Australia
• St. George Hospital — Kogarah, New South Wales, Australia
• Pinnacle Oncology Hematology — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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