Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

HIPEC, Intravenous Chemotherapy and Surgery for the Treatment of Advanced GC With Peritoneal Metastasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02549911
Recruitment Status : Unknown
Verified September 2015 by Zhejiang Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : September 15, 2015
Last Update Posted : September 15, 2015
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital

Brief Summary:
Explore the hyperthermic intraperitoneal chemotherapy (HIPEC) and intravenous chemotherapy for Creating the Operation Chance in advanced gastric cancer with peritoneal metastasis.

Condition or disease Intervention/treatment Phase
Gastric Cancer Other: HIPEC,Chemotherapy AND surgery Phase 2

Detailed Description:
To assess the effectiveness and safety of Hyperthermic intraperitoneal chemotherapy, intravenous chemotherapy combined with surgery for the treatment of advanced gastric cancer with peritoneal metastasis,so as to further find out the optimal protocol for the Conversion therapy in the patients with advanced gastric cancer.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperthermic Intraperitoneal Chemotherapy, Intravenous Chemotherapy Combined With Surgery for the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis
Study Start Date : September 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: HIPEC,Chemotherapy AND surgery
  1. surgical exploration,if PCI<20,then we perform this study
  2. HIPEC(RHL-2000B, Madain Medical Devices Co., Ltd., Jilin, China): Taxol (Paclitaxel Injection) 75 mg/m2, twice, within 72 hours after surgical exploration ; oral chemotherapy:S-1(Tegafur,Gimeracil and Oteracil Potassium Capsules): 80mg/m2, twice daily (after the breakfast and supper) for two weeks, and then suspend for one week.
  3. chemotherapy(3 cycles) : Taxol 150mg/m2,d1, S-1: 80mg/m2, twice daily (after the breakfast and supper) for two weeks, and then suspend for one week.
  4. surgery:Secondary surgical exploration:if PCI less than 20,then perform the cytoreductive surgery(resection of primary tumors and metastases )
  5. after the surgery,HIPEC for two cycles,and PS chemotherapy for 3 cycles
Other: HIPEC,Chemotherapy AND surgery
  1. HIPEC(RHL-2000B, Madain Medical Devices Co., Ltd., Jilin, China): Taxol (Paclitaxel Injection) 75 mg/m2, twice, within 72 hours after surgical exploration ; oral chemotherapy:S-1(Tegafur,Gimeracil and Oteracil Potassium Capsules): 80mg/m2, twice daily (after the breakfast and supper) for two weeks, and then suspend for one week.
  2. chemotherapy(PS for 3 cycles) : Taxol 150mg/m2,d1, S-1: 80mg/m2, twice daily (after the breakfast and supper) for two weeks, and then suspend for one week.
  3. surgery:Secondary surgical exploration:if PCI less than 20,then perform the cytoreductive surgery(resection of primary tumors and metastases )
  4. after the surgery,HIPEC for two cycles,and PS chemotherapy for 3 cycles




Primary Outcome Measures :
  1. R0 resection [ Time Frame: 3 months ]
    the rate of R0 resection


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 6 months ]
    Number and degree of Adverse Events

  2. Overall survival time [ Time Frame: 3 years ]
    the overall survival time



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

gastric cancer confirmed by endoscopic biopsy , and enhanced CT suspected to have peritoneal metastasis, including ascites, ovarian metastasis, omentum or peritoneal metastasis.

  • Definitely diagnosed as above stage of stomach cancer before the operation via CT or MRI, ultrasonic endoscopy and blood tumor antigen test, or through the laparoscopy if necessary
  • Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
  • ECOG (Eastern Cooperative Oncology Group) : 0~2
  • Age: 18~75 years old
  • Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). For example: WBC>4.0×109/L, NEU >1.5×109/L, PLT>100×109/L, BIL<1.5 times of upper limit of normal reference value, ALT and AST<2.5 times of upper limit of normal reference value, and CRE<1.2mg/dl
  • Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases
  • Not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver)
  • Not participating in other study projects before and during the treatment
  • Signed the Informed Consent Form

Exclusion Criteria:

  • Not conforming to above inclusion criteria
  • Distal metastasis to lung, liver, or para aortic lymph node metastasis
  • Ever operation on the stomach
  • Operation intolerance due to other systemic basic diseases
  • Ever administered other drugs (including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after the recruitment
  • Allergy to the drugs in this protocol
  • Pregnant or lactating women
  • Women at childbearing age and of pregnancy desire during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02549911


Contacts
Layout table for location contacts
Contact: Yian Du, MD 86-571-88128031 ypfzmu@163.com
Contact: Pengfei Yu, MD 86-571-88128031 ypfzmu@163.com

Locations
Layout table for location information
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Yian Du, MD    86-571-88128031    ypfzmu@163.com   
Contact: Pengfei Yu, MD    86-571-88128031    ypfzmu@163.com   
Principal Investigator: Yian Du, MD         
Sub-Investigator: Pengfei Yu, MD         
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
Layout table for investigator information
Principal Investigator: Yian Du, MD Zhejiang Cancer Hospital
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT02549911    
Other Study ID Numbers: HISA
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: September 15, 2015
Last Verified: September 2015
Keywords provided by Zhejiang Cancer Hospital:
chemotherapy
surgery
Surgically-Created Resection Cavity
Adverse Reaction to Drug
Additional relevant MeSH terms:
Layout table for MeSH terms
Stomach Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases