UMIN ID: UMIN000000464
Registered date:11/08/2006
Phase 1/2 study of the combination of nedaplatin and ifosfamide in patients with advanced or recurrent cervical cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Advanced or recurrent cervical cancer |
| Date of first enrollment | 2006/08/01 |
| Target sample size | 25 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Combination chemotherapy with nedaplatin and ifosfamide |
Outcome(s)
| Primary Outcome | Recommended dose Dose limiting toxicity Response rate |
|---|---|
| Secondary Outcome | Time to progression Overall survaival Toxicity |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Female |
| Include criteria | |
| Exclude criteria | 1) Severe complications: a) infections, diarrhea (watery), ileus, interstistial pneumonitis, lung fibrosis, b) massive pleural effusion or ascites, c) uncontrollable diabetes mellitus, d) other complications which suffer from progressing study. 2) Co-existence of active other malignancies. 3) Whom the investigator think unappropriate as a candidate. |
Related Information
| Primary Sponsor | Graduate School of Medicine, Chiba University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | none |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| Affiliation | Graduate School of Medicine, Chiba University Reproductive Medicine |
| scientific contact | |
| Name | Akira Mitsuhashi |
| Address | 1-8-1 Inohana chuoku, chiba 260-8670, japan Japan |
| Telephone | |
| Affiliation | Graduate School of Medicine, Chiba University Reproductive Medicine |