Phase II trial of dosetaxel and carboplatin as neoadjuvant chemotherapy in patients with stage Ib2-II nonsquamous cell carcinoma of uterine cervix
Phase 2
- Conditions
- nonsquamous cell carcinoma of uterine cervix
- Registration Number
- JPRN-UMIN000000560
- Lead Sponsor
- Sankai Gynecology Study Group (SGSG)
- Brief Summary
The response rate was 69 % (95 % CI, 57-82 %), with 5 patients achieving complete response, 31 partial response, 15 stable disease, and 1 progressive disease. Median follow-up duration was 1913 days with a range of 145-2632 days. Of 52 patients, 50 underwent radical hysterectomy after neoadjuvant chemotherapy. The 2-year overall survival rate was 81.8 % for stage IB2, 85.7 % for stage IIA2, and 92.6 % for stage IIB.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 61
Inclusion Criteria
Not provided
Exclusion 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy
- Secondary Outcome Measures
Name Time Method Safety