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Status:

COMPLETED

A Study of 5-FU Versus MTX+5-FU in Gastric Cancer With Peritoneal Metastasis

Lead Sponsor:

Japan Clinical Oncology Group

Collaborating Sponsors:

Ministry of Health, Labour and Welfare, Japan

Conditions:

Gastric Cancer

Neoplasm Metastasis

Eligibility:

All Genders

20-75 years

Phase:

PHASE3

Brief Summary

To develop effective chemotherapy regimen against gastric cancer with peritoneal metastasis

Detailed Description

Peritoneal metastasis is common in advanced gastric cancer and is considered an incurable disease state. Peritoneal metastasis may cause serious complications, such as intestinal obstruction, massive ...

Eligibility Criteria

Inclusion

  • histologic confirmation of gastric adenocarcinoma
  • inoperable metastatic disease or recurrent metastatic disease after surgery
  • disease with peritoneal metastasis
  • 20 years or more but less than 75 years
  • performance status 2 or less on the Eastern Cooperative Oncology Group scale
  • no prior treatment for gastric carcinoma except for surgery and adjuvant chemotherapy
  • no prior chemotherapy or radiotherapy for other disease except for gastric cancer
  • adequate bone marrow function, adequate liver function, and adequate renal function
  • no prior transfusion for anemia
  • provision of written informed consent

Exclusion

  • Massive pleural effusion
  • brain metastasis with symptoms
  • severe diarrhea
  • other severe medical conditions (infection, diabetes, hypertension, acute myocardial infarction, unstable angina, liver cirrhosis, intestinal pneumonia, pulmonary fibrosis)
  • other active malignancies

Key Trial Info

Start Date :

November 1 2002

Trial Type :

INTERVENTIONAL

End Date :

April 1 2008

Estimated Enrollment :

160 Patients enrolled

Trial Details

Trial ID

NCT00149201

Start Date

November 1 2002

End Date

April 1 2008

Last Update

February 3 2009

Active Locations (34)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 9 (34 locations)

1

Aichi Cancer Center Hospital

1-1,Kanokoden,Chikusa-ku,Nagoya, Aichi-ken, Japan, 464-8681

2

Aichi Cancer Center,Aichi Hospital

18,Kuriyado,Kake-machi,Okazaki, Aichi-ken, Japan, 444-0011

3

Nagoya Medical Center

4-1-1,Sannomaru,Naka-ku,Nagoya, Aichi-ken, Japan, 460-0001

4

Aomori Prefectural Central Hospital

2-1-1,Higashitsukurimiti,Aomori, Aomori, Japan, 030-0911