Randomized Controlled Trials on Adjuvant Intraperitoneal Chemotherapy for Resectable Local Advanced Gastric Cancer

Advanced Gastric Cancer Clinical Trial

— IPchemo-AGC  

Official title:

Randomized Controlled Trials on Adjuvant Intraperitoneal Chemotherapy for Resectable Local Advanced Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00992199
• Other study ID #: IP chemo-AGC
• Status: Recruiting
• Phase: Phase 2
• First received: October 8, 2009
• Last updated: September 7, 2010
• Start date: August 2009
• Est. completion date: December 2011

Study information

• Verified date: September 2010
• Source: Fudan University
• Contact: Jin Li, MD
• Phone: 86(021)64175590
• Email: fudanlijin[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 79
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• cisplatin, Fluorouracil
cisplatin,60mg,plus 5-Fu,1.0g,intraperitoneal administration,once a week for 3 times

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metastasis in Peritoneum and peritoneal cavity		1 year	Yes
Secondary	Liver metastasis		1 year	Yes
Secondary	Refraction-free survival		1 year	Yes
Secondary	Overall survival		1 year	Yes