UMIN ID: C000000123
Registered date:07/09/2005
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)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | gastric cancer with peritoneal metastasis |
| Date of first enrollment | 2002/10/01 |
| Target sample size | 236 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | A: 5-FU continuous infusion B: MTX+5-FU sequential therapy |
Outcome(s)
| Primary Outcome | overall survival |
|---|---|
| Secondary Outcome | oral intake, toxicity |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Japan Clinical Oncology Group(JCOG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) | NCT00149201 |
Contact
| public contact | |
| Name | Kuniaki Shirao, MD,PhD |
| Address | 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 JAPAN Japan |
| Telephone | |
| JCOG_sir@ml.jcog.jp | |
| Affiliation | JCOG0106 coordinating Office Gatrointestinal Oncology Division, National Cancer Center Hospital |
| scientific contact | |
| Name | Kuniaki Shirao, MD,PhD |
| Address | 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 JAPAN Japan |
| Telephone | |
| Affiliation | National Cancer Center Hospital Gatrointestinal Oncology Division |