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

Japan Clinical Oncology Group

Status and phase: Completed; Phase 3

Conditions: Gastric Cancer; Neoplasm Metastasis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00149201

JCOG0106-MF

C000000123

Details and patient eligibility

About

To develop effective chemotherapy regimen against gastric cancer with peritoneal metastasis

Full 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.

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)