DRKS00003078已完成3 期
Prospective multicenter phase III clinical trial using cytoreductive surgery with hyperthermic intraoperative chemotherapy (HIPEC)after preoperative chemotherapy in patients with peritoneal carcinomatosis of gastric cancer incl. adenocarcinoma of the esophagogastreal junction - Gastripec I
Charité Campus Charité Mitte0 个研究点目标入组 105 人开始时间: 2011年11月23日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1. Histological proved diagnosis of peritoneal metastasized gastric cancer including carcinoma of the AEG
- •No evidence of other distant metastases than peritoneal carcinomatosis with exception of Krukenberger tumors
- •2. Peritoneal Staging with laparoscopy (or explorative laparotomy) and estimation of Peritoneal Cancer Index (PCI) with the possibility of 80% tumorreduction at cytoreductive surgery
- •3. = 18 and = 75 years
- •4. Karnofsky Index 70% or better
- •5.Written informed consent is obtained prior to commencement of trial treatment.
排除标准
- •1. Other than peritoneal metastasis of the gastric cancer incl. AEG and Krukenberg
- •2.Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix
- •3.Any previous chemotherapy or radiotherapy, and any investigational treatment for gastric cancer
- •4.Active systemic infections
- •5.Patients with known interstitial lung disease with New York Heart Association classification > 2
- •6.Serious cardiac dysrhythmia or condition, New York Heart Association classification of III or IV, congestive cardiac failure
- •7. cardiac arrhythmia
- •8.Uncontrolled hypertension (diastolic blood pressure constantly >100 mm Hg, systolic blood pressure constantly > 180 mm Hg).
- •9.Inadequate bone marrow function at the beginning of the trial, defined as platelet count less than <150 GPT/L or neutrophil granulocyt count less than <1.5 GPT/L
- •10. cardiac function EF < 55%
- •11.Inadequate renal function at the beginning of the trial, defined as GFR less than <60 ml/min
- •12.Inadequate liver function at the beginning of the trial, defined as Bilirubin >1.5 times ULN
- •13.Active vaccination within 6 weeks prior to randomisation
- •14.Active hepatitis B or C infection
- •15.Female patients who are pregnant or breast feeding
- •16.Fertile female patients (defined as women with less than a 12-month elapse after the last menstruation) not using an acceptable form of contraception during the trial
- •17. Missing of capacity to contract
- •18.contraindication to the drugs which are used in the trial
- •19.Participation in another therapeutic clinical trial
- •20. Persons institutionalised due to regulatory actions ore by court order.
研究者
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