Cytoreductive Surgery Combined With HIPEC and Chemotherapy for Gastric Cancer With Peritoneal Metastasis

September 11, 2019 updated by: Guoxin Li, Nanfang Hospital of Southern Medical University

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

This study evaluates the survival benefit and safety of cytoreductive surgery(CRS) combined with HIPEC and chemotherapy in gastric cancer with peritoneal metastasis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hao Liu, M.D., Ph.D.
  • Phone Number: +86-138-2215-8578
  • Email: liuhaofbi@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100-142
        • Recruiting
        • Peking University Cancer Hospital
        • Contact:
          • Xiangqian Su, M.D., Ph.D.
          • Phone Number: +86-138-0126-2916
        • Principal Investigator:
          • Xiangqian Su, M.D., Ph.D
    • Fujian
      • Fuzhou, Fujian, China, 350-014
        • Recruiting
        • Fujian Provincial Hospital
        • Contact:
          • Liangxiang Huang, M.D., Ph.D.
          • Phone Number: 0086-138-5902-0211
        • Principal Investigator:
          • Liangxiang Huang, M.D., Ph.D.
    • Guangdong
      • Guangzhou, Guangdong, China, 510-515
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:
      • Guangzhou, Guangdong, China, 510-060
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:
        • Principal Investigator:
          • Zhiwei Zhou, M.D., Ph.D.
      • Guangzhou, Guangdong, China, 510-080
        • Recruiting
        • Guangdong General Hospital
        • Contact:
      • Guangzhou, Guangdong, China, 510-095
        • Recruiting
        • Cancer Center of Guangzhou Medical University
        • Contact:
        • Principal Investigator:
          • cuishuzhong@126.com Cui, M.D., Ph.D.
      • Guangzhou, Guangdong, China, 510-280
        • Recruiting
        • Zhujiang Hospital of Southern Medical University
        • Contact:
        • Principal Investigator:
          • Jinlong Yu, M.D., Ph.D.
      • Guangzhou, Guangdong, China, 510-630
        • Recruiting
        • The Third Affiliated Hospital of Sun Yat-sen University
        • Contact:
          • Hong-Bo Wei, M.D., Ph.D.
          • Phone Number: 0086-18922102969
          • Email: drweihb@126.com
        • Contact:
        • Principal Investigator:
          • Hong-Bo Wei, M.D., Ph.D.
      • Guangzhou, Guangdong, China, 510-655
        • Recruiting
        • The Sixth Affiliated Hospital of Sun Yat-sen University
        • Contact:
        • Principal Investigator:
          • Junsheng Peng, M.D., Ph.D.
      • Meizhou, Guangdong, China, 514-031
        • Recruiting
        • Meizhou People's Hospital
        • Contact:
        • Principal Investigator:
          • Zuguang Wu, M.D.
      • Zhongshan, Guangdong, China, 528-403
        • Recruiting
        • Zhongshan City People Hospital
        • Contact:
        • Principal Investigator:
          • Hong Chen, M.D., Ph.D.
    • Shanghai
      • Shanghai, Shanghai, China, 200-032
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Contact:
        • Principal Investigator:
          • Yihong Sun, M.D., Ph.D.
    • Sichuan
      • Chengdu, Sichuan, China, 610-041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
          • Jiankun Hu, M.D., Ph.D.
          • Phone Number: +86-189-8060-1504
          • Email: hujkwch@126.com
        • Principal Investigator:
          • Jiankun Hu, M.D.,Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Procedure: Cytoreductive surgery

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.

Other Names:
  • CRS , Cytoreduction Surgical Procedures
Procedure: Hyperthermic Intraperitoneal Chemotherapy
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.
Other Names:
  • HIPEC
Drug: Fluoropyrimidine
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.
Other Names:
  • fluorouracil or capecitabine
Drug: Cisplatin
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.
Other Names:
  • cis-diamine dichloroplatinum(CDDP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year Median survival time
Time Frame: 24 months
The time point when the cumulative survival rate is 50% according to the survival curve.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year overall survival rate
Time Frame: 24 months
Overall survival rate calculated according to the survival curve.
24 months
Progression free survival rate
Time Frame: 24 months
Progression free survival rate calculated according to the disease progression curve.
24 months
Morbidity and mortality
Time Frame: 30 days; 24 months
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
30 days; 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life(site-specific module for gastric cancer)
Time Frame: Every 6 months to 2 years
Evaluated according to European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Stomach(EORTC QLQ-STO22)
Every 6 months to 2 years
Quality of life
Time Frame: Every 6 months to 2 years
Evaluated according to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cancer (EORTC QLQ-C30)
Every 6 months to 2 years
circulating tumor cell（CTC） alteration
Time Frame: Every 6 months to 2 years
Every 6 months to 2 years
circulating tumor DNA（ctDNA）alteration
Time Frame: Every 3 months to 2 years
Every 3 months to 2 years
Molecular biomarker alteration
Time Frame: Every 6 months to 2 years
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.
Every 6 months to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Investigators

  • Principal Investigator: Guoxin Li, Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group; Nanfang Hospital, Southern Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2022

Study Completion (ANTICIPATED)

June 1, 2022

Study Registration Dates

First Submitted

January 9, 2017

First Submitted That Met QC Criteria

January 14, 2017

First Posted (ESTIMATE)

January 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2019

Last Update Submitted That Met QC Criteria

September 11, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLASS - 05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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