Cytoreductive Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy and Systemic Chemotherapy in Gastric Cancer With Regional Peritoneal Metastasis, a Multicenter and Single-arm Phase III Study
试验速览
- 阶段
- 3 期
- 入组人数
- 220
- 试验地点
- 13
- 主要终点
- 2-year Median survival time
研究概览
简要总结
This study evaluates the survival benefit and safety of cytoreductive surgery(CRS) combined with HIPEC and chemotherapy in gastric cancer with peritoneal metastasis.
详细描述
Peritoneal metastasis is one of the most frequent non-curable factors in advanced gastric cancer with poor prognosis, the median survival time of patients is less than 1 year and even worse in China. Recently, several new modalities have been developed and reported to improve survival, including the new chemotherapeutic agents, molecular targeting agents and hyperthermic intraperitoneal chemotherapy（HIPEC）.Still, the long-term outcomes based on multicenter randomized clinical trials (RCTs) are awaited.
The surgical approach to metastatic lesions has been proved to play a very crucial role in prolonging the survival of metastatic colorectal patients, which might be able to cure patients with the operation aiming at R0 resection. For patients with metastatic gastric cancer, surgical intervention of primary tumor and measurable metastatic lesion is technically feasible, while the survival benefit is controversial. 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 and new categories of classification for metastatic gastric cancer based on the treatment response is needed.
In order to evaluate the survival benefit and safety of cytoreductive surgery(CRS) and HIPEC before beginning chemotherapy in gastric cancer with peritoneal metastasis, patients who fulfill the inclusion and exclusion criteria will be recruited in this study and receive CRS, HIPEC and chemotherapy. Chemotherapy regimen based on cisplatin and fluorouracil(CF) are recommended. Patients are followed up for 2 years and the safety and survival outcome will be analyzed.
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
- 19 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from over 18 to under 75 years
- •Histologically proven primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy
- •Diagnosed with clinical T1-4N0-3M1（distant metastases confined to peritoneum, P1）according to the American Joint Committee on Cancer(AJCC) Cancer Staging Manual Seventh Edition by laparoscopic exploration
- •Localized peritoneal metastasis with peritoneal cancer index(PCI) less than 20
- •Resection of primary tumor and metastasis is anticipated to reach the CC0 status(no residual tumor )
- •Performance status of 0 or 1 on Eastern Cooperative Oncology Group(ECOG) scale
- •Written informed consent
排除标准
- •Adenocarcinoma of esophageal-gastric junction(AEG) that requires thoracotomy
- •Distant metastases not confined to peritoneum, including liver (H1), para-aortic lymphnode (stations 16a1 and/or b2), lung, brain, bone and other organs
- •Histologically proven Human epidermal growth factor receptor 2(HER2)-neu overexpressing adenocarcinoma
- •History of previous neoadjuvant chemotherapy , radiotherapy or clinical trial treatment within 3 months
- •Contraindication for anesthesia, surgery, chemotherapeutic agents or HIPEC
- •Women of child-bearing potential who are pregnant or breastfeeding
- •History of prior/other malignancies within the 5 years prior to enrollment
- •Cerebrovascular accident occurred within 6 months (myocardial infarction, unstable angina, cerebral infarction, or cerebral hemorrhage)
- •History of continuous systematic administration of corticosteroids within one month
- •Requirement of simultaneous surgery for other disease
- •Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- •FEV1<50% of predicted values
研究组 & 干预措施
CRS + HIPEC + Systemic Chemotherapy
Cytoreductive surgery(CRS) followed by Hyperthermic Intraperitoneal Chemotherapy(HIPEC) and systemic chemotherapy will be performed for the treatment of patients assigned to this group.
CF regimens or other first line regimens based on Fluoropyrimidine and Cisplatin according to the National Comprehensive Cancer Network（NCCN） Guidelines （Gastric Cancer，version 3.2016) are recommended.Regimens and dosing schedules are not limited in this trial.
干预措施: Cytoreductive surgery (Procedure)
CRS + HIPEC + Systemic Chemotherapy
Cytoreductive surgery(CRS) followed by Hyperthermic Intraperitoneal Chemotherapy(HIPEC) and systemic chemotherapy will be performed for the treatment of patients assigned to this group.
CF regimens or other first line regimens based on Fluoropyrimidine and Cisplatin according to the National Comprehensive Cancer Network（NCCN） Guidelines （Gastric Cancer，version 3.2016) are recommended.Regimens and dosing schedules are not limited in this trial.
干预措施: Hyperthermic Intraperitoneal Chemotherapy (Procedure)
CRS + HIPEC + Systemic Chemotherapy
Cytoreductive surgery(CRS) followed by Hyperthermic Intraperitoneal Chemotherapy(HIPEC) and systemic chemotherapy will be performed for the treatment of patients assigned to this group.
CF regimens or other first line regimens based on Fluoropyrimidine and Cisplatin according to the National Comprehensive Cancer Network（NCCN） Guidelines （Gastric Cancer，version 3.2016) are recommended.Regimens and dosing schedules are not limited in this trial.
干预措施: Fluoropyrimidine (Drug)
CRS + HIPEC + Systemic Chemotherapy
Cytoreductive surgery(CRS) followed by Hyperthermic Intraperitoneal Chemotherapy(HIPEC) and systemic chemotherapy will be performed for the treatment of patients assigned to this group.
CF regimens or other first line regimens based on Fluoropyrimidine and Cisplatin according to the National Comprehensive Cancer Network（NCCN） Guidelines （Gastric Cancer，version 3.2016) are recommended.Regimens and dosing schedules are not limited in this trial.
干预措施: Cisplatin (Drug)
结局指标
主要结局
2-year Median survival time
时间窗: 24 months
The time point when the cumulative survival rate is 50% according to the survival curve.
次要结局
- Morbidity and mortality(30 days; 24 months)
- 2-year overall survival rate(24 months)
- Progression free survival rate(24 months)
研究者
Guoxin Li
Principal Investigator
Nanfang Hospital, Southern Medical University