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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 7, 2005

Last Updated Date

February 2, 2009

Start Date ^†

November 2002

Current Primary Outcome Measures ^†

overall survival

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00149201 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

oral intake
toxicity

Original Secondary Outcome Measures ^†

oral intake
toxicity

Descriptive Information

Brief Title ^†

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

Official Title ^†

Randomized Phase III Study of 5-FU Continuous Infusion (5FUci) Versus MTX+5-FU Sequential Therapy (MF) in Gastric Cancer With Peritoneal Metastasis (JCOG0106-MF, MF/5FU)

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 ascites, and hydronephrosis associated with the clinical presentation of abdominal pain and fullness, vomiting, constipation, malnutrition and renal dysfunction.5-FU continuous infusion remains the mainstay for chemotherapy against gastric cancer. On the other, sequential MTX+5-FU was reported to be effective in advanced gastric cancer with peritoneal metastasis in some phase II studies.

Therefore, the randomized phase III study of 5-FU versus sequential MTX+5-FU in gastric cancer with peritoneal metastasis was conducted.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Gastric Cancer
Neoplasm Metastasis

Intervention ^†

Drug: 5-FU continuous infusion
Drug: MTX + 5-FU sequential therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

160

Completion Date

April 2008

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

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 Criteria:

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

Gender

Both

Ages

20 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Japan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00149201

Responsible Party

Japan Clinical Oncology Group, Japan Clinical Oncology Group

Secondary IDs ^††

C000000123

Study Sponsor ^†

Japan Clinical Oncology Group

Collaborators ^††

Japanese Ministry of Health, Labor and Welfare

Investigators ^†

Study Chair:

Kuniaki Shirao, MD,PhD

Gatrointestinal Oncology Division, National Cancer Center Hospital

Information Provided By

Japan Clinical Oncology Group

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.