EUCTR2008-003737-25-IT进行中（未招募）不适用
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 - SIRFLOX study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 318
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Willing and able to provide written informed consent.
- •- Histologically confirmed adenocarcinoma of the colon or rectum OR radiological evidence of carcinoma of the colon or rectum. - 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 - Limited extra-hepatic metastases in the lung and/or abdominal lymph nodes are permitted. Metastases in the lung must be not more than five nodules in number with no nodule more than 1 cm in diameter. Involvement of abdominal lymph nodes are permitted provided they measure less than 2 cm in diameter. - Suitable for either treatment regimen as determined by clinical assessment undertaken by the Investigator. - Prior chemotherapy for metastatic colorectal cancer is not allowed. Patients may have received both adjuvant chemotherapy and/or radiotherapy following resection of the primary colorectal cancer, provided the last dose of chemotherapy and/or radiotherapy was administered at least 6 months prior to entry into this study. - WHO performance status 0 - 1 - Adequate haematological, renal and hepatic function - Aged 18 years or older. - Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active using an acceptable method of contraception. - Male patients must be surgically sterile or if sexually active and having a pre-menopausal partner must be using an acceptable method of contraception. - Life expectancy of at least 3 months without any active treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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. - Previous radiotherapy delivered to the upper abdomen. - Non-malignant disease that would render the patient unsuitable for treatment according to this protocol. - Equivocal, immeasurable, or unevaluable metastases in the liver. - Peripheral neuropathy > grade 1 (NCI-CTCv3). - Dose-limiting toxicity associated with previous adjuvant 5-FU or oxaliplatin chemotherapy. - Previous chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is not an exclusion criteria provided that it was completed more than 6 months before the documentation of metastatic disease. - Pregnant or breast feeding. - Other active malignancy.
研究者
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