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



Status:Active, not recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/19/2016
Start Date:February 2013
End Date:December 2019

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Assessment of Overall Survival of FOLFOX6m Plus SIR-Spheres Microspheres Versus FOLFOX6m Alone as First-line Treatment in Patients With Non-resectable Liver Metastases From Primary Colorectal Carcinoma in a Randomised Clinical Study

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.


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
We found this trial at
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24 Sturtevant St
Orlando, Florida 32806
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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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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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Buffalo, New York 14263
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111 Colchester Ave
Burlington, Vermont 05401
(802) 847-0000
Fletcher Allen Health Care As Vermont’s University Medical Center, we at Fletcher Allen are committed...
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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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Dallas, Texas 75203
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Duarte, California 91010
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Gosford, New South Wales 2250
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Hinsdale, Illinois
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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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Morgantown, West Virginia 26505
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New Orleans, Louisiana 70121
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New York, New York 10021
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Pembroke Pines, Florida 33028
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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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Salt Lake City, Utah 84124
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Spartanburg, South Carolina 29303
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