UMIN ID: UMIN000000564
Registered date:01/01/2007
Phase II trial of docetaxel and carboplatin in patients with stage IVb or recurrent 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 | 50 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Patients with stage IVb recurrent nonsquamous cell carcinoma of uterine cervix |
Outcome(s)
| Primary Outcome | Efficacy |
|---|---|
| Secondary Outcome | Safety, Overall survival |
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.Massive pleural effusion and ascites 8.Hypersensitivity reactions to docetaxel or carboplatin 9.Patients judged as exclusive case by the investigator |
Related Information
| Primary Sponsor | Sankai Gynecology Study Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Sankai Gynecology Study Group |
| 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, Shimame Japan |
| Telephone | 0852-60-8000 |
| mshima12@med.tottori-u.ac.jp | |
| Affiliation | Matsue city hospital Department of Obstetrics and Gynecology |