NCT02456714已完成2 期
Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年5月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- pilot study: toxicity
研究概览
简要总结
Cholangiocarcinoma, is a malignant gastrointestinal tumor of low incidence with a poor prognosis. Chemotherapy is the most common treatment for advanced disease. On the basis of a phase III clinical study, cisplatin plus gemcitabine is considered standard first-line treatment in advanced cholangiocarcinoma patients, but there is no established second line therapy.
Since fluorouracil and leucovorin combined with irinotecan and oxaliplatin (FOLFIRINOX) appears to be safe and demonstrated efficacy in clinical studies of advanced pancreatic cancer, colorectal cancer and a phase I study in cholangiocarcinoma, this combination could be an effective second-line treatment for patients with advanced cholangiocarcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological diagnosis of cholangiocarcinoma.
- •Metastatic disease or irresectable locally advanced cholangiocarcinoma.
- •Measurable disease according RECIST criteria version 1.
- •Age from 18 to 75 year.
- •WHO/ECOG performance status 0-
- •Patients who received at least 3 cycles of gemcitabine/cisplatin in the first line.
- •Adequate hematological function (WBC > 3.0 x 109/L, platelets > 100 x109/L)
- •Adequate hepatic function (bilirubin ≤ 1.5 x upper normal limit (ULN); ALAT or ASAT <5x ULN in case of liver metastases and < 2.5 x ULN in absence of liver metastases.
- •Adequate renal function (creatinine clearance > 60 ml/min; creatinine <120 µmol/L)
- •Absence of cardiac insufficiency, chest pain (not medically controlled) and myocardial infarction in the 12 months preceding study entry.
- •Signed informed consent.
排除标准
- •Concurrent secondary malignancies or other malignancies within 3 years prior to enter this study with the exception of non-metastatic basal cell or squamous cell skin cancer or carcinoma in situ of the cervix treated by cone-biopsy or resection
- •Presence of cerebral or meningeal metastases
- •Contraindication to any of the substances of the planned treatment.
- •History of chronic diarrhea or colorectal inflammatory conditions, or of unresolved occlusion or sub-occlusion for which symptomatic treatment is being administered
- •Active infection or other serious underlying conditions which may prevent the patient from receiving the planned treatment. For example: prolonged unresolved bacterial cholangitis with destruction of bile duct branches (e.g. after endoprosthesis insertion) or two or more cholangitis in the last 6 months. Patients with other active or uncontrolled severe infection, cirrhosis or chronic active hepatitis will be excluded.
- •Presence of cardiac insufficiency, unstable angina pectoris, symptomatic congestive heart, failure myocardial infarction 6 months prior to randomization, serious uncontrolled cardiac arrhythmia.
- •Inclusion in another investigational clinical trial
- •Women who are pregnant, breast-feeding or not using adequate contraceptive
- •Age younger than 18 or older than 76 years
- •Individuals under correctional supervision or guardianship
研究组 & 干预措施
Progressive cholangiocarcinoma, second line treatment
Experimental
FOLFIRINOX
干预措施: FOLFIRINOX (Drug)
结局指标
主要结局
pilot study: toxicity
时间窗: 24 weeks
number of adverse events in accordance with CTCAEv4.0
phase II: the response rate
时间窗: 24 weeks
次要结局
- phase II: toxicity during the treatment period and 30 days after the treatment.(24 weeks)
- phase II: the overall survival.(24 weeks)
- phase II: time to progression.(24 weeks)
- phase II: quality of life(24 weeks)
- pilot study: the response rate(24 weeks)
- pilot study: the overall survival(24 weeks)
- pilot study: quality of life(24 weeks)
- pilot study: time to progression.(24 weeks)
研究者
Heinz-Josef Klumpen
Dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
研究点 (1)
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