Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sirtex Medical
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer
