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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00992199
First received: October 8, 2009
Last updated: September 7, 2010
Last verified: September 2010
  Purpose

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 Intervention Phase
Advanced Gastric Cancer
Drug: cisplatin, Fluorouracil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Controlled Trials on Adjuvant Intraperitoneal Chemotherapy for Resectable Local Advanced Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Metastasis in Peritoneum and peritoneal cavity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Liver metastasis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Refraction-free survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 79
Study Start Date: August 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

DISEASE CHARACTERISTICS

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

PATIENT CHARACTERISTICS:

  • Age: 18 - 70years old

Life expectancy:

  • Longer than 3 months

Hematopoietic:

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

Hepatic:

- AST no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Other:

  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

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

Radiotherapy:

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

Surgery:

  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00992199

Contacts
Contact: Jin Li, MD 86(021)64175590 ext 5108 fudanlijin@163.com
Contact: xiaodong Zhu, MD 86(021)64175590 ext 5008 xddr001@163.com

Locations
China, Shanghai
Fudan University Cancer Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Jin Li, MD    86(021)64175590 ext 5108    fudanlijin@163.com   
Contact: Xiaodong Zhu, MD    86(021)64175590 ext 5008    xddr001@163.com   
Principal Investigator: Jin Li, MD         
Sub-Investigator: Haiyi Guo, MD         
Sub-Investigator: xiaodnog Zhu, MD         
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Jin Li, MD member of Fudan University Cancer Hospital
  More Information

No publications provided

Responsible Party: Haiyi Guo, Fudan University Cancer Hospital
ClinicalTrials.gov Identifier: NCT00992199     History of Changes
Other Study ID Numbers: IP chemo-AGC
Study First Received: October 8, 2009
Last Updated: September 7, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Fudan University:
intraperitoneal chemotherapy
cisplatin
fluorouracil
advanced gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014