Colon Cancer Clinical Trial
FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer
Summary
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.
Eligibility 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.
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There are 76 Locations for this study
Scottsdale Arizona, 85258, United States
Duarte California, 91010, United States
North Miami Beach Florida, 33169, United States
Berwyn Illinois, 60402, United States
Chicago Illinois, 60612, United States
Harvey Illinois, 80426, United States
Hinsdale Illinois, 60525, United States
Louisville Kentucky, 40202, United States
Baltimore Maryland, 21201, United States
Royal Oak Michigan, 48073, United States
Minneapolis Minnesota, 55407, United States
Teaneck New Jersey, 07666, United States
Bronx New York, 10467, United States
Charlotte North Carolina, 28203, United States
Charlotte North Carolina, 28203, United States
Grand Forks North Dakota, 58201, United States
Pittsburgh Pennsylvania, 15232, United States
Salt Lake City Utah, 84124, United States
Seattle Washington, 98109, United States
Milwaukee Wisconsin, 53215, United States
Milwaukee Wisconsin, 53226, United States
Concord New South Wales, 2139, Australia
Darlinghurst New South Wales, 2010, Australia
Kingswood New South Wales, , Australia
Kogarah New South Wales, 2217, Australia
St Leonards New South Wales, 2065, Australia
Wahroonga New South Wales, 2076, Australia
Westmead New South Wales, 2145, Australia
Auchenflower Queensland, 4066, Australia
Cairns Queensland, 4870, Australia
Herston Queensland, 4029, Australia
Southport Queensland, 4215, Australia
Southport Queensland, 4215, Australia
Woolloongabba Queensland, , Australia
Adelaide South Australia, , Australia
Ashford South Australia, , Australia
Bedford Park South Australia, , Australia
Elizabeth Vale South Australia, 5012, Australia
Woodville South South Australia, , Australia
Hobart Tasmania, 7000, Australia
Bentleigh East Victoria, , Australia
Coburg Victoria, 3058, Australia
Footscray Victoria, 3011, Australia
Frankston Victoria, 3199, Australia
Noble Park Victoria, 3174, Australia
Parkville Victoria, 3050, Australia
Ringwood East Victoria, 3135, Australia
Ringwood Victoria, 3135, Australia
Nedlands Western Australia, 6009, Australia
Nedlands Western Australia, , Australia
Perth Western Australia, 6005, Australia
Perth Western Australia, , Australia
Aalst , 9300, Belgium
Antwerpen , 2020, Belgium
Antwerp , , Belgium
Bonheiden , 2820, Belgium
Bornem , 2880, Belgium
Brussels , , Belgium
Gent , 9000, Belgium
Gent , , Belgium
Haine-Saint-Paul , 7100, Belgium
Leuven , 3000, Belgium
Liege , , Belgium
Mechelen , 2800, Belgium
Reet , 2840, Belgium
Wilrijk , 2610, Belgium
Bordeaux , 33000, France
La Tronche , 38700, France
Longjumeau , 91161, France
Nice , 06202, France
Paris , 7590, France
Rennes Cedex , , France
Altstadt , 84028, Germany
Berlin , 1335, Germany
Bonn , 53123, Germany
Bonn , , Germany
Bonn , , Germany
Essen , 45136, Germany
Essen , , Germany
Frankfurt , 6059, Germany
Hamburg , 20367, Germany
Hamburg , , Germany
Holzkirch , 83607, Germany
Ingolstadt , 85049, Germany
Karlsruhe , 76133, Germany
Magdeburg , 39104, Germany
Magdeburg , 39130, Germany
Magdeburg , , Germany
Marburg , 35043, Germany
Muenchen , , Germany
Muenchen , , Germany
Munchen , , Germany
Munchen , , Germany
Munchen , , Germany
Velbert , 42551, Germany
Weilheim , , Germany
Haifa , , Israel
Jerusalem , 91031, Israel
Petah Tiqva , 49100, Israel
Ramat Gan , 52621, Israel
Tel Aviv , 64239, Israel
Bologna , 40138, Italy
Auckland , , New Zealand
Christchurch , , New Zealand
Dunedin , , New Zealand
Newtown , , New Zealand
Palmerston , , New Zealand
Warsaw , 04-14, Poland
Pamplona , 31008, Spain
Pamplona , 31008, Spain
Zurich , CH-80, Switzerland
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