Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Peritoneal Carcinosis Free Survival
研究概览
简要总结
Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer
详细描述
The gastric carcinoma is one of the four most common tumors occurring worldwide. The advanced phase is characterized by metastasis and poses a very poor prognosis for survival. In 20%-30% of gastric carcinomas the tumor spreads into the abdominal cavity, which leads to metastases in the wall of the peritoneal cavity. This is known as peritoneal carcinomatosis and its five-year survival rate is less than 2%. Even after R0 resection of a localized gastric carcinoma the five-year survival rate is only 40%, not least of all because relapses in the form of peritoneal metastases are a common occurrence.
Patients with gastric carcinoma and not yet diagnosed with metastases, but who show free tumor cells in cytology in preoperative laparoscopy before neoadjuvant chemotherapy and gastrectomy, have an 80% risk of developing peritoneal carcinomatosis within one year, which stands in strong contrast to the 40% risk for patients with negative cytology.
In the study presented here (group A) therapeutic hyperthermic intraperitoneal chemoperfusion (HIPEC, in the literature also known as HIIC (heated intraoperative intraperitoneal chemotherapy) or IPHC (intraperitoneal chemohyperthermia)) with mitomycin c and cisplatin will be administered following gastrectomy in patients with a gastric carcinoma with free tumor cells in cytology diagnosed in the preoperative laparoscopy in comparison to (group B) solely gastrectomy in patients with a gastric carcinoma and also with free tumor cells diagnosed in cytology in the preoperative laparoscopy.
A randomization will be performed between group A and B. Patients with gastric carcinoma (TNM Stage ≥ T2<T4) without proven metastases (TNM stage M0), with and without involved regional lymph nodes (TNM stage +N/-N) and positive cytology in preoperative abdominal lavage will be included. Exclusion criteria are extended disease or inoperable tumor.
This study is already permitted by the local ethic commission and the German Federal Institute for Drugs and Medical Devices (BfArM) (EudraCT-Nr.: 2011-004405-25 / Study code: HIPEC_Stomach) and was initiated in August 2012.
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
- •Histologically proven gastric adenocarcinoma: uT1,uT2, uT3, Nx, M0
- •No prior chemotherapy
- •Patients of full age, independent of gender ECOG ≤ 2
- •No dissemination of the tumor confirmed by CT of the lung and the abdomen.
- •Signed Consent form of the Patient agreeing to investigations
- •Leucocytes > 3.000/µl
- •Thrombocytes > 100.000/µl
- •Creatinine ≤ 1.5mg/dl and or Clearance > 60 ml/min
- •informed consent of the patient
- •normal ejection-fraction of the heart
排除标准
- •Dissemination of the tumor or non-resectable primary tumor
- •Malignant secondary disease < 5 years in the past (Exception: in-situ-carcinoma of the cervix and appropriately treated basal cell carcinoma of the skin)
- •Patient not of full age
- •Inflammatory chronic bowel disease
- •Inclusion of the patient in a different study
- •Pregnancy or lactation
研究组 & 干预措施
positive cytology with HIPEC
gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative
干预措施: positive cytology with HIPEC (Drug)
结局指标
主要结局
Peritoneal Carcinosis Free Survival
时间窗: 5 Years
Three patients were enrolled in the study. No study results because no patient has received study drug.
Disease Free Survival
时间窗: 5 years
No study results because no patient has received study drug.
次要结局
未报告次要终点