UMIN ID: UMIN000000560
Registered date:01/01/2007
Phase II trial of dosetaxel and carboplatin as neoadjuvant chemotherapy in patients with stage Ib2-II nonsquamous cell carcinoma of uterine cervix
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | nonsquamous cell carcinoma of uterine cervix |
| Date of first enrollment | 2006/12/01 |
| Target sample size | 60 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | patients with stage Ib2 or II with diameter of over 2 cm nonsquamous cell carcinoma of uterine cervix |
Outcome(s)
| Primary Outcome | Efficacy |
|---|---|
| Secondary Outcome | Safety |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Female |
| Include criteria | |
| Exclude criteria | 1 fever with over 38.0C 2 infection or WBC>12,000/mm3 3 severe complications 4 neuropathy >Grade 2 5 edema > Grade 2 6 double cancer 7 pleural effusion and ascites for which drainage are necessary. 8 previous chemotherapy by taxane compounds |
Related Information
| Primary Sponsor | Sankai Gynecology Study Group (SGSG) |
|---|---|
| Secondary Sponsor | none |
| Source(s) of Monetary Support | none |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Muneaki Shimada |
| Address | 36-1 Nishimachi, Yonago Japan Japan 683-8504 |
| Telephone | 0859-38-6647 |
| mshima12@med.tottori-u.ac.jp | |
| Affiliation | Tottori University Department of Obstetrics and Gynecology |
| scientific contact | |
| Name | Junzo Kigawa |
| Address | 32-1 Noshiro-cho, Matsue, Shimane Japan |
| Telephone | 0852-60-8000 |
| mshima12@med.tottori-u.ac.jp | |
| Affiliation | Matsue city hospital Department of Obstetrics and Gynecology |