Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant/Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- median overall survival
研究概览
简要总结
In this multicenter study, patients with resectable pancreatic carcinoma will be treated with (a) surgery followed by 6 cycles gemcitabine or (b) 4-6 cycles FOLFIRINOX followed by surgery followed by 4-6 cycles FOLFIRINOX.
The overall survival between both therapies will be compared as well as other parameters.
详细描述
This is a phase II/III randomized multicenter study. Patients with resectable pancreatic carcinoma will be randomized in Arm A (surgery plus adjuvant gemcitabine, 6 cycles) or Arm B (4-6 cycles FOLFIRINOX neoadjuvant, 4-6 cycles FOLFIRINOX adjuvant).
Primary endpoint is the overall survival, secondary endpoints are progression-free survival, perioperative morbidity and mortality, rate of R0 resections, tolerability and feasibility of neoadjuvant FOLFIRINOX and others.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the pankreas. For histological confirmation, max. 3 tests are allowed. If no confirmation of carcinoma is possible, the patient can not be included into the study.
- •Radiological confirmation of a locally limited curativ resectable (primarily resectale or borderline situation) pankreas carcinoma without distant metastases.
- •no prior pancreas resection
- •no prior cytostatic chemotherapy
- •female and male patients > 18 and <=75 years using contraception
- •medical resectability
- •granulocytes > 1.500/µl
- •thrombocytes > 100.000/µl
- •hemoglobin ≥ 8,0 g/dl
- •serumcreatinine ≤ 1.5x of normal value or Creatinine-Clearance > 50 ml/min
- •written informed consent
排除标准
- •Endocrine pancreas carcinoma
- •locally advanced inoperable stages: non-resectable infiltration of V. porta or longway infiltration of A. mesenterica superior or infiltration of Truncus coeliacus.
- •distant metastases
- •prior radiotherapy of measurable lesions
- •peritonealcarcinosis
- •malignant secondary disease, dated back < 5 years (exeption: in-situ-carcinoma of the cervix, adequately treated skin basal cell carcinoma)
- •contraindication for operative resection
- •severe liver dysfunction (AST/ALT>3,5xULN, AP>6xULN)
- •Transhepatic drainage
- •active CHD (symptoms present), cardiomyopathy or heart insufficiency stage III-IV according to NYHA and EF < 45%
- •severe non-surgical accompanying diseases or acute infection
- •chronic diarrhea
- •chronic inflammable gastro-intestinal disease
- •peripheral polyneuropathy > NCI grade II
- •pregnancy or lactation
- •hypersensibility or contraindication for Gemcitabine, Oxaliplatin, Natriumfolinate, Irinotecan or 5-Fluorouracil
- •participation in another interventional trial
研究组 & 干预措施
FOLFIRINOX
Oxaliplatin 85mg/m², Irinotecan 180mg/m², 5-FU 400mg/m² Bolus i.v., 5-FU continuous Infusion 2400 mg/m² Natriumfolinate 400mg/m² 46h d1; qd15 6 cycles pre- and 6 cycles post- surgery
干预措施: Oxaliplatin (Drug)
FOLFIRINOX
Oxaliplatin 85mg/m², Irinotecan 180mg/m², 5-FU 400mg/m² Bolus i.v., 5-FU continuous Infusion 2400 mg/m² Natriumfolinate 400mg/m² 46h d1; qd15 6 cycles pre- and 6 cycles post- surgery
干预措施: 5-Fluorouracil (Drug)
FOLFIRINOX
Oxaliplatin 85mg/m², Irinotecan 180mg/m², 5-FU 400mg/m² Bolus i.v., 5-FU continuous Infusion 2400 mg/m² Natriumfolinate 400mg/m² 46h d1; qd15 6 cycles pre- and 6 cycles post- surgery
干预措施: Irinotecan (Drug)
FOLFIRINOX
Oxaliplatin 85mg/m², Irinotecan 180mg/m², 5-FU 400mg/m² Bolus i.v., 5-FU continuous Infusion 2400 mg/m² Natriumfolinate 400mg/m² 46h d1; qd15 6 cycles pre- and 6 cycles post- surgery
干预措施: Natriumfolinate (Drug)
Gemcitabine
Gemcitabine 1000 mg/m² d1, d8, d15; qd 29; 6 cycles after surgery
干预措施: Gemcitabine (Drug)
结局指标
主要结局
median overall survival
时间窗: From date of randomization until the date of death from any cause assessed up to 24 months
次要结局
- median progression-free survival (PFS)(From date of randomization until the date of first documented progression / relapse or date of death from any cause, whichever came first, assessed up to 24 months)
- perioperative morbidity and mortality(30 days after surgery)
- R0 resection rate(2 months after surgery)
- adverse events (grade, number per patient) related to of G-CSF prophylaxis in the Folfirinox arm(up to 40 weeks)
- pathological complete remission(at surgery)
- prevalence of iron deficiency(baseline, d1 of every cycle, end of treatment)