A Phase III Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Combined With Systemic Chemotherapy And Cytoreductive Surgery (CRS) in the Treatment of Peritoneal Carcinomatosis From Gastric Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Median overall survival
研究概览
简要总结
This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy that stage IV limited peritoneal metastasis of gastric cancer patients accept hyperthermic intraperitoneal chemotherapy plus neoadjuvant chemotherapy with CRS and systemic chemotherapy. With advanced-stage gastric patients of confined to the peritoneal as the research object, with median progression-free survival and overall survival, adverse events as the end points.
详细描述
Peritoneal metastases in gastric cancer are considered as terminal disease with poor prognosis, the median survival time of this kind of patients is less than 1 year and even worse in China. Recently, cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) has been suggested to improve survival in patients with peritoneal metastases from gastric cancer. Even though the REGATTA trial demonstrated that the removal of the primary tumor is not necessarily beneficial, the role of operation aiming at R0 resection combined with new regimens like HIPEC and new chemotherapeutic agents is still confusing. Neoadjuvant chemotherapy prolonged OS of patients received macroscopically radical (CC0) surgery. Compared to systemic chemotherapy, HIPEC promotes chemotherapy to penetrate deeper into the cancer tissue, which needed multicenter randomized clinical trials (RCTs) to comfirm. Therefore, we has conducting prospective phase III trial of HIPEC combined with systemic chemotherapy and CRS for gastric cancer with peritoneal metastasis.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastic adenocarcinoma is diagnosed by histological and cytological examination.
- •Peritoneal carcinomastosis of gastric cancer is diagnosed by laparotomy or laparoscopic exploration.
- •According to Sugarbaker's peritoneal cancer index (PCI), PCI score of participant is no more than
- •18 < Age < 70 year old
- •Expected survival > 3 months
- •Performance status: ECOG 0-1
- •Adequate bone marrow function Hb ≥9 g/dl (After correction in case of iron deficient anemia) WBC ≥ 3,500/mm3, Platelet ≥ 100,000/mm3
- •Adequate renal function Creatinine ≤ 1.5 mg/dl, and adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 2.5×ULN
- •Voluntary participation after getting written informed consent.
排除标准
- •Except for peritoneal carcinomatosis, gastric cancer concurrently metastasized to liver, lung, para-aortic lymph node and other distant organs.
- •Extensive adhesion in peritoneal cavity
- •Previous History of other malignancies
- •Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction<50%
- •Receiving other chemotherapy, radiotherapy or immunotherapy
- •Patients who are unsuitable candidates by doctor's decision
- •Without given written informed consent
结局指标
主要结局
Median overall survival
时间窗: 3 years
assess median overall survival rate during 3 years in both study arms
次要结局
- Risk factors for morbidity and mortality(Through study completion, an average of 1 year.)
研究者
Shu-Zhong Cui
President of Affiliated Tumor Hospital of Guangzhou Medical
Affiliated Cancer Hospital & Institute of Guangzhou Medical University