UMIN ID: UMIN000002041
Registered date:03/06/2009
A phase I trial of combination chemotherapy with docetaxel and 5-fluorouracil (DF) for advanced esophagogastric carcinoma (KDOG 0902 P1)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | advanced or recurrent esophagogastric carcinoma |
| Date of first enrollment | 2009/04/01 |
| Target sample size | 20 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | docetaxel and 5-fluorouracil |
Outcome(s)
| Primary Outcome | To estimate the maximum tolerated dose and the recommended dose |
|---|---|
| Secondary Outcome | safety efficacy |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Administration of the blood transfusion or G-CSF within 7 days before registration 2. History of serious drug hypersensitivity 3. Active infection 4. Watery diarrhea 5. Uncontrolled ileus 6. Active gastrointestinal bleeding 7. Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema or etc) 8. Symptomatic brain metastasis 9. Active synchronous or metachronous malignancy, excepting for esophageal and gastric carcinoma 10. Severe abnormality of ECG, severe heart disease (congestive heart failure, symptomatic ischemic heart disease, uncontrolled arrhythmia, history of myocardial infarction within 12 months, or etc) 11. Severe mental disorders, neurological disease 12. Pregnant or lactation women, or women with the possibility of the pregnancy and men who want let to pregnancy 13. Patients who are judged inappropriate for the entry into this study by the investigator |
Related Information
| Primary Sponsor | Kitasato University School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Kitasato University School of Medicine, Department of Gastroenterology |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | 2-1-1, Asamizodai, Sagamihara, Kanagawa, Japan Japan |
| Telephone | |
| Affiliation | Kitasato University School of Medicine Department of Gastroenterology |
| scientific contact | |
| Name | Wasaburo Koizumi |
| Address | 2-1-1, Asamizodai, Sagamihara, Kanagawa, Japan Japan |
| Telephone | |
| Affiliation | Kitasato University School of Medicine Department of Gastroenterology |