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

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00149201

Enrollment

160

Registered

2005-09-08

Start date

2002-11-30

Completion date

2008-04-30

Last updated

2009-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Neoplasm Metastasis

Keywords

gastric cancer, peritoneal metastasis, randomized trial, 5-FU, MTX

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.

Interventions

DRUG5-FU continuous infusion

DRUGMTX + 5-FU sequential therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. histologic confirmation of gastric adenocarcinoma 2. inoperable metastatic disease or recurrent metastatic disease after surgery 3. disease with peritoneal metastasis 4. 20 years or more but less than 75 years 5. performance status 2 or less on the Eastern Cooperative Oncology Group scale 6. no prior treatment for gastric carcinoma except for surgery and adjuvant chemotherapy 7. no prior chemotherapy or radiotherapy for other disease except for gastric cancer 8. adequate bone marrow function, adequate liver function, and adequate renal function 9. no prior transfusion for anemia 10. provision of written informed consent

Exclusion criteria

1. Massive pleural effusion 2. brain metastasis with symptoms 3. severe diarrhea 4. other severe medical conditions (infection, diabetes, hypertension, acute myocardial infarction, unstable angina, liver cirrhosis, intestinal pneumonia, pulmonary fibrosis) 5. other active malignancies

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
oral intake	—
toxicity	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026