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

October 8, 2009
September 7, 2010
August 2009
October 2011   (final data collection date for primary outcome measure)
Metastasis in Peritoneum and peritoneal cavity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00992199 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Randomized Controlled Trials on Adjuvant Intraperitoneal Chemotherapy for Resectable Local Advanced Gastric Cancer
Randomized Controlled Trials on Adjuvant Intraperitoneal Chemotherapy for Resectable Local Advanced Gastric Cancer

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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Advanced Gastric Cancer
Drug: cisplatin, Fluorouracil
cisplatin,60mg,plus 5-Fu,1.0g,intraperitoneal administration,once a week for 3 times
Other Name: DDP,5-Fu
  • No Intervention: control arm
    adjuvant intravenous system chemotherapy
  • Experimental: IP Chemo arm
    adjuvant system intravenous chemotherapy combined with adjuvant intraperitoneal chemotherapy
    Intervention: Drug: cisplatin, Fluorouracil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
79
December 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Jin Li, MD 86(021)64175590 ext 5108 fudanlijin@163.com
Contact: xiaodong Zhu, MD 86(021)64175590 ext 5008 xddr001@163.com
China
 
NCT00992199
IP chemo-AGC
Yes
Haiyi Guo, Fudan University Cancer Hospital
Fudan University
Not Provided
Principal Investigator: Jin Li, MD member of Fudan University Cancer Hospital
Fudan University
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP