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

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Advanced Gastric Cancer

Treatments: Drug: cisplatin, Fluorouracil

Study type: Interventional

Funder types: Other

Identifiers

NCT00992199

IP chemo-AGC

Details and patient eligibility

About

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.

Full description

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

Enrollment: 79 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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79 participants in 2 patient groups

control arm

No Intervention group

Description:

adjuvant intravenous system chemotherapy

IP Chemo arm

Experimental group

Description:

adjuvant system intravenous chemotherapy combined with adjuvant intraperitoneal chemotherapy

Treatment:

Drug: cisplatin, Fluorouracil