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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 83
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control Arm
Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.
干预措施: FOLFOX6m (Drug)
Experimental Arm
Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.
干预措施: FOLFOX6m (Drug)
Experimental Arm
Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.
干预措施: SIR-Spheres microspheres (Device)
结局指标
主要结局
Overall Survival (OS)
时间窗: From date of randomization until the date of death from any cause assessed up 3 yrs 8 months
OS defined as the time interval between the date of randomization and the date of death from any cause.
次要结局
- Progression-free Survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years 8 months.)