Randomized Controlled Trials on Adjuvant Intraperitoneal Chemotherapy for Resectable Local Advanced Gastric Cancer (IPchemo-AGC)

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. Identifier: NCT00992199
Recruitment Status : Unknown
Verified September 2010 by Fudan University.
Recruitment status was:  Recruiting
First Posted : October 9, 2009
Last Update Posted : September 8, 2010
Information provided by:
Fudan University

Brief Summary:

Gastric cancer is the leading cause of death from a intestinal tract cancer in China.In most cases, the high death rate is due to tumor that has spread beyond the gastric cancer at the time of diagnosis. In China, the standard chemotherapy for the initial treatment of gastric cancer is a combination of a platinum analogue with 5-Fu.With modern surgical interventions and contemporary chemotherapy, most patients attain better clinical remission.The majority of them, however, will eventually have a relapse and die of the disease.

The peritoneal cavity is the principal site of disease in gastric cancer.Although the intensity of intravenous chemotherapy is limited mainly by myelotoxicity, several active drugs can be administered directly into the peritoneal cavity. The rationale for intraperitoneal therapy in gastric cancer is that the peritoneum, the predominant site of tumor, receives sustained exposure to high concentrations of antitumor agents while normal tissues, such as the bone marrow, are relatively spared.

The investigators conducted this trial to investigate the efficacy and safety of intraperitoneal chemotherapy in advanced gastric cancer.

Condition or disease Intervention/treatment Phase
Advanced Gastric Cancer Drug: cisplatin, Fluorouracil Phase 2

Detailed Description:
To investigate efficacy and safety of intraperitoneal chemotherapy as part of adjuvant treatment for advanced gastric cancer.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trials on Adjuvant Intraperitoneal Chemotherapy for Resectable Local Advanced Gastric Cancer
Study Start Date : August 2009
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
No Intervention: control arm
adjuvant intravenous system chemotherapy
Experimental: IP Chemo arm
adjuvant system intravenous chemotherapy combined with adjuvant intraperitoneal chemotherapy
Drug: cisplatin, Fluorouracil
cisplatin,60mg,plus 5-Fu,1.0g,intraperitoneal administration,once a week for 3 times
Other Name: DDP,5-Fu

Primary Outcome Measures :
  1. Metastasis in Peritoneum and peritoneal cavity [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Liver metastasis [ Time Frame: 1 year ]
  2. Refraction-free survival [ Time Frame: 1 year ]
  3. Overall survival [ Time Frame: 1 year ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:


  • Histologically confirmed primary adenocarcinoma of the stomach
  • 3-4weeks after radical operation for gastric cancer
  • Stage of the gastric cancer was T3-4NxM0


  • Age: 18 - 70years old

Life expectancy:

  • Longer than 3 months


  • Granulocyte count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 80*10^12/mm3


- AST no greater than 2.5 times ULN


  • Creatinine no greater than 1.5 times ULN


  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • Prior chemotherapy and radiotherapy were not allowed
  • No other concurrent chemotherapy


  • Locally radiotherapy for local disease of advanced gastric cancer during adjuvant treatment was allowed


  • See Disease Characteristics
  • Prior surgery for gastric cancer was necessary

Exclusion Criteria:

  • Haven't recovery from operation or complication of operation
  • With the following risk factors: Uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension)
  • Pregnant or nursing
  • Other currently active malignancy except nonmelanoma skin cancer
  • Uncontrolled or severe bleeding,diarrhea,intestinal obstruction,adhesion of intestine
  • metastasis before enrollment
  • Received other chemotherapy or radiotherapy after operation

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 identifier (NCT number): NCT00992199

Contact: Jin Li, MD 86(021)64175590 ext 5108
Contact: xiaodong Zhu, MD 86(021)64175590 ext 5008

China, Shanghai
Fudan University Cancer Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Jin Li, MD    86(021)64175590 ext 5108   
Contact: Xiaodong Zhu, MD    86(021)64175590 ext 5008   
Principal Investigator: Jin Li, MD         
Sub-Investigator: Haiyi Guo, MD         
Sub-Investigator: xiaodnog Zhu, MD         
Sponsors and Collaborators
Fudan University
Principal Investigator: Jin Li, MD member of Fudan University Cancer Hospital

Responsible Party: Haiyi Guo, Fudan University Cancer Hospital Identifier: NCT00992199     History of Changes
Other Study ID Numbers: IP chemo-AGC
First Posted: October 9, 2009    Key Record Dates
Last Update Posted: September 8, 2010
Last Verified: September 2010

Keywords provided by Fudan University:
intraperitoneal chemotherapy
advanced gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs