UMIN ID: C000000193
Registered date:12/09/2005
Randomized phase III trial comparing adjuvant oral UFT/LV to 5-FU/l-LV in stage III colorectal cancer (JCOG-0205-MF)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Stage III colorectal cancer |
| Date of first enrollment | 2003/02/01 |
| Target sample size | 1100 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | A: 5FU+l-leucovorin B: UFT+Leucovorin |
Outcome(s)
| Primary Outcome | Disease-free survival |
|---|---|
| Secondary Outcome | Overall survival, Rate of adverse event |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Active co-existing malignancy (synchronous or metachronous malignancy whose disease free period is within 5 years). Carcinoma in situ is eligible. 2) Severe postoperative complicatoins which do not resolve until registration. 3) There is following complicaion. insulin-controlling or uncontrollable diabetes mellitus, uncontrollable hypertension, myocardial infarction within six month or unstable angina pactoris, liver cirrhosis, interstitial pneumonia, pulmonary fibrosis, severe emphysema 4) Pregnant or breast-feeding woman. 5) Difficult to participate with the trial, having mentel disorder or psychiatric symptoms. 6) Judged to be inappropriate to register. |
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) | NCT00190515 |
Contact
| public contact | |
| Name | Yasuhiro Shimada, MD |
| Address | 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan 104-0045 Japan |
| Telephone | |
| JCOG_sir@ml.jcog.jp | |
| Affiliation | JCOG0205 Coordinating Office Division of medical oncology, National Cancer Center Hospital |
| scientific contact | |
| Name | Yasuhiro Shimada, MD |
| Address | 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan 104-0045 Japan |
| Telephone | |
| Affiliation | National Cancer Center Hospital Division of medical oncology |