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



Status:Completed
Conditions:Colorectal Cancer, Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/28/2019
Start Date:August 2006
End Date:May 2015

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Randomised Comparative Study Of Folfox6m Plus Sir-Spheres® Microspheres Versus Folfox6m Alone As First Line Treatment In Patients With Nonresectable Liver Metastases From Primary Colorectal Carcinoma

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.


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.
We found this trial at
22
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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100 NW 170th St # 410
North Miami Beach, Florida 33169
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Berwyn, Illinois 60402
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Charlotte, North Carolina 28203
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
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Concord, New South Wales 2138
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Duarte, California 91010
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Grand Forks, North Dakota 58201
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1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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Hinsdale, Illinois 60521
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
414-649-6000
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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Minneapolis, Minnesota 55408
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Royal Oak, Michigan 48073
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Salt Lake City, Utah 84124
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Scottsdale, Arizona 85258
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Teaneck, New Jersey 07666
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