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


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Advanced Gastric Cancer

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Metastasis in Peritoneum and peritoneal cavity

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Jin Li, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

member of Fudan University Cancer Hospital

Authority:

China: Food and Drug Administration

Study ID:

IP chemo-AGC

NCT ID:

NCT00992199

Start Date:

August 2009

Completion Date:

December 2011

Related Keywords:

  • Advanced Gastric Cancer
  • intraperitoneal chemotherapy
  • cisplatin
  • fluorouracil
  • advanced gastric cancer
  • Stomach Neoplasms

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