Back to resultsCytoreductive Surgery Combined With HIPEC and Chemotherapy for Gastric Cancer With Peritoneal Metastasis
Primary Purpose
Stomach Neoplasm
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Cytoreductive surgery
Hyperthermic Intraperitoneal Chemotherapy
Fluoropyrimidine
Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasm focused on measuring Stomach Neoplasms, Cytoreduction Surgical Procedures
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Peking University Cancer HospitalRecruiting
- Fujian Provincial HospitalRecruiting
- Sun Yat-sen University Cancer CenterRecruiting
- Guangdong General HospitalRecruiting
- Cancer Center of Guangzhou Medical UniversityRecruiting
- Zhujiang Hospital of Southern Medical UniversityRecruiting
- Nanfang Hospital, Southern Medical UniversityRecruiting
- The Third Affiliated Hospital of Sun Yat-sen UniversityRecruiting
- The Sixth Affiliated Hospital of Sun Yat-sen UniversityRecruiting
- Meizhou People's HospitalRecruiting
- Zhongshan City People HospitalRecruiting
- Zhongshan Hospital, Fudan UniversityRecruiting
- West China Hospital, Sichuan UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CRS + HIPEC + Systemic Chemotherapy
Arm Description
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.
Outcomes
Primary Outcome Measures
2-year Median survival time
The time point when the cumulative survival rate is 50% according to the survival curve.
Secondary Outcome Measures
2-year overall survival rate
Overall survival rate calculated according to the survival curve.
Progression free survival rate
Progression free survival rate calculated according to the disease progression curve.
Morbidity and mortality
The early complication and mortality are defined as the event observed within 30 days after intervention, while the time frame for late complication is the period beyond 30 days after intervention to the end of month 24th. Complications are ranked from grade 0-5 according to CTCAE V4.0
Full Information
NCT ID
NCT03023436
First Posted
January 9, 2017
Last Updated
September 11, 2019
Sponsor
Nanfang Hospital, Southern Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03023436
Brief Title
Cytoreductive Surgery Combined With HIPEC and Chemotherapy for Gastric Cancer With Peritoneal Metastasis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study evaluates the survival benefit and safety of cytoreductive surgery(CRS) combined with HIPEC and chemotherapy in gastric cancer with peritoneal metastasis.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasm
Keywords
Stomach Neoplasms, Cytoreduction Surgical Procedures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CRS + HIPEC + Systemic Chemotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cytoreductive surgery
Other Intervention Name(s)
CRS , Cytoreduction Surgical Procedures
Intervention Description
Gastrectomy with D2 lymph node dissection and Metastasectomy for peritoneal metastatic sites only.
A total, distal, or proximal gastrectomy and the type of reconstruction will be selected according to the surgeon's experience.
Metastasectomy is limited to peritoneal metastatic sites only to render the patient no evidence of disease (NED) with at least 1cm negative margins when possible.
Intervention Type
Procedure
Intervention Name(s)
Hyperthermic Intraperitoneal Chemotherapy
Other Intervention Name(s)
HIPEC
Intervention Description
Docetaxel 120 mg diluted in 5.0 L of saline is forced into the abdomen through the inflow catheter by a pump and pulled out through the drains as a heated intraperitoneal perfusion.A heat exchanger keeps the intraperitoneal fluid at 43±0.5℃ and duration limited to 70 minutes.24 hours after cytoreductive surgery no less than 2 cycles postoperative chemotherapy will be recommended.
Intervention Type
Drug
Intervention Name(s)
Fluoropyrimidine
Other Intervention Name(s)
fluorouracil or capecitabine
Intervention Description
CF regimens or other first line regimens based on Fluoropyrimidine and Platinum according to the NCCN Guidelines（Gastric Cancer，version 3.2016) are recommended.Regimens and dosing schedules are not limited in this trial.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
cis-diamine dichloroplatinum(CDDP)
Intervention Description
CF regimens or other first line regimens based on Fluoropyrimidine and Platinum according to the NCCN Guidelines（Gastric Cancer，version 3.2016) are recommended.Regimens and dosing schedules are not limited in this trial.
Primary Outcome Measure Information:
Title
2-year Median survival time
Description
The time point when the cumulative survival rate is 50% according to the survival curve.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
2-year overall survival rate
Description
Overall survival rate calculated according to the survival curve.
Time Frame
24 months
Title
Progression free survival rate
Description
Progression free survival rate calculated according to the disease progression curve.
Time Frame
24 months
Title
Morbidity and mortality
Description
The early complication and mortality are defined as the event observed within 30 days after intervention, while the time frame for late complication is the period beyond 30 days after intervention to the end of month 24th. Complications are ranked from grade 0-5 according to CTCAE V4.0
Time Frame
30 days; 24 months
Other Pre-specified Outcome Measures:
Title
Quality of life(site-specific module for gastric cancer)
Description
Evaluated according to European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Stomach(EORTC QLQ-STO22)
Time Frame
Every 6 months to 2 years
Title
Quality of life
Description
Evaluated according to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cancer (EORTC QLQ-C30)
Time Frame
Every 6 months to 2 years
Title
circulating tumor cell（CTC） alteration
Time Frame
Every 6 months to 2 years
Title
circulating tumor DNA（ctDNA）alteration
Time Frame
Every 3 months to 2 years
Title
Molecular biomarker alteration
Description
Molecular biomarker includes 14 genes（TP53, BAI1, THSD1, ARID2, KIAA2022, ERBB4, ZNF721, NT5E, PDE10A, CA1, NUMB, NBN, ZFYVE16 and NCAM1） according to the whole-exome sequencing results.
Time Frame
Every 6 months to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guoxin Li, M.D., Ph.D.
Phone
+86-138-0277-1450
Email
gzliguoxin@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Liu, M.D., Ph.D.
Phone
+86-138-2215-8578
Email
liuhaofbi@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guoxin Li
Organizational Affiliation
Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group; Nanfang Hospital, Southern Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100-142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangqian Su, M.D., Ph.D.
Phone
+86-138-0126-2916
First Name & Middle Initial & Last Name & Degree
Xiangqian Su, M.D., Ph.D
Facility Name
Fujian Provincial Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350-014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liangxiang Huang, M.D., Ph.D.
Phone
0086-138-5902-0211
First Name & Middle Initial & Last Name & Degree
Liangxiang Huang, M.D., Ph.D.
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510-060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiwei Zhou, M.D., Ph.D.
Phone
+86-139-0222-2859
Email
zhouzhw@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Zhiwei Zhou, M.D., Ph.D.
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510-080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Li, M.D., Ph.D.
Phone
+86-138-2217-7479
Email
yuan821007@126.com
First Name & Middle Initial & Last Name & Degree
Yong Li, M.D., Ph.D.
Facility Name
Cancer Center of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510-095
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuzhong Cui, M.D., Ph.D.
Phone
+86-138-0251-3800
Email
cuishuzhong@126.com
First Name & Middle Initial & Last Name & Degree
cuishuzhong@126.com Cui, M.D., Ph.D.
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510-280
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinlong Yu, M.D., Ph.D.
Phone
+86-131-8909-7861
Email
yujinlong640506@163.com
First Name & Middle Initial & Last Name & Degree
Jinlong Yu, M.D., Ph.D.
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510-515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoxin Li, M.D., Ph.D.
Phone
+86-138-0277-1450
Email
gzliguoxin@163.com
First Name & Middle Initial & Last Name & Degree
Hao Liu, M.D., Ph.D.
Phone
+86-138-2215-8578
Email
liuhaofbi@163.com
First Name & Middle Initial & Last Name & Degree
Guoxin Li, M.D., Ph.D.
Facility Name
The Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510-630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong-Bo Wei, M.D., Ph.D.
Phone
0086-18922102969
Email
drweihb@126.com
First Name & Middle Initial & Last Name & Degree
Bo Wei, M.D.
Phone
0086-13527794069
Email
sanpi2013@163.com
First Name & Middle Initial & Last Name & Degree
Hong-Bo Wei, M.D., Ph.D.
Facility Name
The Sixth Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510-655
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junsheng Peng, M.D., Ph.D.
Phone
+86-138-0296-3578
Email
pengsir1010@126.com
First Name & Middle Initial & Last Name & Degree
Junsheng Peng, M.D., Ph.D.
Facility Name
Meizhou People's Hospital
City
Meizhou
State/Province
Guangdong
ZIP/Postal Code
514-031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zuguang Wu, M.D.
Phone
+86-135-0252-3063
Email
wuzg1913@163.com
First Name & Middle Initial & Last Name & Degree
Zuguang Wu, M.D.
Facility Name
Zhongshan City People Hospital
City
Zhongshan
State/Province
Guangdong
ZIP/Postal Code
528-403
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Chen, M.D., Ph.D.
Phone
+86-135-9084-3781
Email
cenhong228@sohu.com
First Name & Middle Initial & Last Name & Degree
Hong Chen, M.D., Ph.D.
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200-032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yihong Sun, M.D., Ph.D.
Phone
+86-137-0173-5406
Email
yihongsun@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Yihong Sun, M.D., Ph.D.
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610-041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiankun Hu, M.D., Ph.D.
Phone
+86-189-8060-1504
Email
hujkwch@126.com
First Name & Middle Initial & Last Name & Degree
Jiankun Hu, M.D.,Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
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Cytoreductive Surgery Combined With HIPEC and Chemotherapy for Gastric Cancer With Peritoneal Metastasis
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