Randomised Comparative Study of folinic acid, 5-fluorouracil and oxaliplatin (FOLFOX6m) Plus SIR-Spheres(r) versus FOLFOX6m alone treatment on progression-free survival in first line patients with non-resectable Liver Metastases from Primary Colorectal Carcinoma

Sirtex Technology Pty Ltd0 个研究点目标入组 318 人开始时间: 2006年5月2日最近更新: 2020年1月13日

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•Histologically confirmed adenocarcinoma of the colon or rectum OR radiological evidence of carcinoma of the colon or rectum together with elevated serum CEAUnequivocal contrast CT OR histologic/cytologic evidence of malignant metastases in the liverLimited extra-hepatic metastases in the lung and/or abdominal lymph nodes are permitted. Metastases in the lung must not be more than 5 nodules in number with no nodule more than 2 cm in diameter. Involvement of abdominal lymph nodes are permitted provided they measure less than 5 cm in diameter.All imaging evidence used as a basis for study entry must be less than 29 days old at the time of study entry.Liver metastases are not treatable by surgical resection or by some form of local ablation with the intent of curing the patient.Suitable for either treatment regimen as determined by clinical assessment undertaken by the investigator.Prior chemotherapy for metastatic colorectal cancer is not allowed.Adequate haematological, renal and hepatic function. Willing and able to provide written informed consentFemale patients must either be post menopausal, sterile or if sexually active using an acceptable method of contraception.Life expectancy of at least 3 months without any active treatment.

•Evidence of ascites, cirrhosis or portal hypertension as determined by clinical or radiologic assessment.Previous radiotherapy delivered to the upper abdomenNon-malignant disease that would render the patient unsuitable for treatment according to protocolEquivocal, immeasurable, or unevaluable metastases in the liverPeripheral neuropathy > grade 1 (NCI-CTC)DLT associated with previous adjuvant 5-FU or oxaliplatin chemotherapyPrevious chemotherapy for any malignancy. Adjuvant chemotherapy completed more than 4 months before the documentation of metastatic disease.Pregnant or breast-feeding womenOther active malignancy.

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