Trial Information

Clinical Investigation Plan STX 0206: Randomised Comparative Study of FOLFOX6m plus SIR-SpheresÒ Microspheres versus FOLFOX6m Alone as First Line Treatment in Patients with Non-Resectable Liver Metastases from Primary Colorectal Carcinoma

Selective Internal Radiation Therapy (SIRT) is a form of treatment that has been designed to selectively deliver radiation to cancer within the liver. The main purpose of this study is to find out if the combination of SIRT and chemotherapy has better results than chemotherapy alone for patients with colorectal cancer that has spread to the liver. Individuals who are eligible to take part in the study will be randomly assigned either to chemotherapy alone or to chemotherapy plus SIRT and will be asked to come to the hospital for the study treatment.

Patient Inclusion Criteria:

Aged 18 years or older
Histologically confirmed adenocarcinoma of the colon or rectum, with or without primary tumour in situ
Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent at the time of trial entry

Patient Exclusion Criteria:

Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis as determined by clinical or radiologic assessment
Any extra-hepatic metastases other than: a) lung metastases that are not more than five nodules in number with no nodule more than 1 cm in diameter and b) involvement of abdominal lymph nodes that measure less than 2 cm in diameter
Pregnant or breast feeding

Joel Victor
Einstein-Montefiore Institute for Clinical & Translational Research
Montefiore Medical Center
Division of Oncology
111 East 210th Street
Bronx, NY 10467
Phone: 718-920-6680
Email: JVICTOR@montefiore.org

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Research Center Information: Einstein-Montefiore Institute for Clinical & Translational Research

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