UMIN ID: UMIN000000962
Registered date:01/01/2008
Phase II study of neoadjuvant chemotherapy TS-1/CPT-11 for advanced lower rectal cancers
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | Rectal cancers |
| Date of first enrollment | 2007/10/01 |
| Target sample size | 25 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Chemotherapy Surgery |
Outcome(s)
| Primary Outcome | 3-year disease-free survival rates |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Excluded are cases with conditions as below: 1) Multiple malignancies to be treated. 2) Previous history of severe drug-induced allergy. 3) Active infectious diseases. 4) Coexistent severe diseases including pulmonary fibrosis, interstitial pneumonia, ileus, uncontrollable diabetes, cardiac dysfunction, hepatic failure, or renal failure. 5) Peritoneal or pleural fluid retention to be drainaged. 6) Symptomatic brain metastases. 7) Active digestive tract bleeding. 8) Severe watery diarrhea. 9) Pregnant. 10) Previous treatment history of radiotherapy. |
Related Information
| Primary Sponsor | Dept. Surgery Kyoto University Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | 075-751-3227 |
| Affiliation | Kyoto University Hospital Surgery |
| scientific contact | |
| Name | Satoshi Nagayama |
| Address | 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto City Japan |
| Telephone | |
| Affiliation | Kyoto University Hospital Surgery |