NCT02465112终止3 期
A Randomized Phase III of Adjuvant Targeted Radionuclide Therapy With In111-Pentetreotide in Patients With Digestive Neuroendocrine Tumors After Complete Surgical Resection of Liver Metastases.
GERCOR - Multidisciplinary Oncology Cooperative Group5 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 5
- 主要终点
- relapse-free survival (RFS)
研究概览
简要总结
TERAVECT is a phase III randomized study of patients with digestive neuroendocrine tumors after complete surgical resection of liver metastases treated with In111-Pentetreotide-based adjuvant radiotherapy.
In this study, targeted radionuclide therapy is used at an earlier stage of the disease.The objective is to target residual tumor cells and/or micrometastases which escaped surgical resection. Given the poor prognosis associated with recurrence, this treatment should prevent relapse.
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
- •Signed and dated informed consent,
- •Age ≥ 18 years,
- •Patients with well differenciated digestive neuroendocrine tumors and liver metastases, for whom a complete surgical resection of liver metastases and of the primary tumor was performed, in 1 or 2 times,
- •Immunohistochemical confirmation of neuroendocrine tumors with WHO 2010 grading specification and Ki67 determined of the surgical specimen,
- •ECOG Performance Status (PS) 0-1,
- •Adequate hematological status: Platelets >100000/mm3, Hemoglobin >10g/dL,
- •Adequate Clearance Creatinine >60 mL/min,
- •Adequate liver function: Total Serum Bilirubin <1.5x upper limit of normal (ULN), transaminases <3 x ULN,
- •Grade of In111-Pentetreotide uptake ≥ 2 (scored according to the Krenning et al scale.: more intense than physiological liver uptake),
- •Treatment started within 14 weeks after surgical resection,
- •Men and women are required to use adequate birth control measures during the course of the study and for a period of 12 months after the last administration of study drug. Female patients with childbearing potential must have a negative serum pregnant test (β-HCG) within 7 days before starting study treatment,
- •Life expectancy >6 months
- •Registration with the National Health Care System (CMU included for France)
排除标准
- •History of previous or second cancer or progressive cancer occurring within 5 years prior to inclusion, except for basal cell or squamous cell carcinoma,
- •Patients with known sensibility or hypersensibility to In111- Pentetreotide or any component of the treatment drug,
- •Pregnant or breast-feeding women without adequate birth control measures,
- •Patient with known medical history of psychological or psychiatric disorders that may affect patient participation in study due to lack of cooperation or loss of autonomy preventing hospitalization and initiation of study treatment (in good radiation protection conditions),
- •Treatment with any investigational drug within 28 days prior to study entry,
- •Patient protected by law (tutelage or guardianship).
研究组 & 干预措施
metabolic radiotherapy
Experimental
In111-Pentetréotide at 12, 18 and 24 weeks after surgery,
干预措施: In111-Pentetréotide (Drug)
No metabolic radiotherapy - simple monitoring
Active Comparator
No metabolic radiotherapy - simple monitoring without theraoy
干预措施: simple monitoring without active therapy (Other)
结局指标
主要结局
relapse-free survival (RFS)
时间窗: up to 3-year
次要结局
- Overall survival (1)(up to 3-year)
- Overall survival (2)(up to 5-year)
- Quality of life (EORTC QLQ-C30)(up to 5-year)
- Tolerability(up to 5-year after surgery)
- Impact of the therapy on 5-year RFS in treatment and control group(Up to 5-year)
- Identify predictive factors of RFS(Up to 3-year)
- Impact of the therapy on 1-year RFS in treatment and control group(Up to 1-year)
研究者
研究点 (5)
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