UMIN ID: UMIN000000820
Registered date:10/09/2007
Randamised phase III trial of adjuvant chemotherapy with gemcitabine vs. observation in patients with resectable bile duct cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Bile duct cancer |
| Date of first enrollment | 2007/09/01 |
| Target sample size | 300 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Adjuvant chemoterapy with gemcitabine Observation following surgery |
Outcome(s)
| Primary Outcome | Over All Survival Time |
|---|---|
| Secondary Outcome | Adverse Events, Recurrence Free Survival Time |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 100years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Pleural effusion or ascites, moderate amount 2. Pericardial effusion 3. NYHA class III or IV 4. Myocardiac infarction in the past 3 months 5. Active viral hepatitis 6. Uncontrolled Diabetes Melitus 7. Blood trasfusion in the past 2 weeks |
Related Information
| Primary Sponsor | Nagoya Surgery Support Organization |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Nagoya Surgery Support Organization |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Tomoki Ebata |
| Address | Japan |
| Telephone | |
| tomoki@med.nagoya-u.ac.jp | |
| Affiliation | Nagoya University, Graduate School of Medicine Divison of Surgical Oncology |
| scientific contact | |
| Name | Masato Nagino |
| Address | 65 Tsurumaicho, Showaku, Nagoya, 466-8550, Japan Japan |
| Telephone | 052-744-2223 |
| Affiliation | Nagoya University, Graduate School of Medicine Divison of Surgical Oncology |