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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 530
- 试验地点
- 111
- 主要终点
- Progression-Free Survival (PFS) at Any Site
研究概览
简要总结
This study is a randomized multi-center trial that will assess the effect of adding Selective Internal Radiation Therapy (SIRT), using SIR-Spheres microspheres®, to a standard chemotherapy regimen of FOLFOX as first line therapy in patients with non-resectable liver metastases from primary colorectal adenocarcinoma.
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 treating 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
- •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).
- •Suitable for either treatment regimen.
- •Prior chemotherapy for metastatic colorectal cancer is not allowed.
- •WHO performance status 0-
- •Adequate hematological, renal and hepatic function.
- •Age 18 years or older.
- •Willing and able to provide written informed consent.
- •Life expectancy of at least 3 months without any active treatment.
- •Exclusion Criteria
- •Evidence of ascites, cirrhosis, portal hypertension, main portal or venous tumor involvement or thrombosis as determined by clinical or radiologic assessment.
- •Previous radiotherapy delivered to the upper abdomen.
- •Non-malignant disease that would render the patient unsuitable for treatment according to the protocol.
- •Peripheral neuropathy > grade 1 (NCI-CTC).
- •Dose limiting toxicity with previous adjuvant 5-FU or oxaliplatin chemotherapy.
- •Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is not an exclusion criteria provided that it was completed more than 6 months before entry into the study.
- •Pregnant or breast-feeding.
- •Other active malignancy.
排除标准
- 未提供
研究组 & 干预措施
mFOLFOX6 + SIRT
A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
干预措施: SIR-Spheres yttrium-90 microspheres (Device)
mFOLFOX6
Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5- Fluorouracil (FOLFOX).
干预措施: Systemic chemotherapy (FOLFOX) (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) at Any Site
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
PFS defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as an increase in the sum of the longest diameters of ≥ 20% and an absolute increase in the sum of the longest diameters of ≥ 5 mm, or the appearance of a new lesion.
次要结局
- Percentage of Participants With Overall Response(Through study completion, up to 60 months)