Prospective Randomized Phase-III-Trial of Paclitaxel plus Topotecan versus Topotecan plus Cisplatin in Recurrent or Persistent Cervical Carcinoma - AGO-Zervix-1
Phase 1
- Conditions
- Chemotherapeutical treatment of patients with recurrent or persistent or metastatic cervical carcinoma stage IVb
- Registration Number
- EUCTR2006-000349-20-BE
- Lead Sponsor
- Institut fuer Frauengesundheit GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 173
Inclusion Criteria
Progressive histologically confirmed carcinoma of the cervix uteri and measurable disease (RECIST) without treatment alternatives to chemotherapy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Both-sided hydronephrosis, CNS-metastases or reduced general condition
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Comparison of overall survival;Secondary Objective: Tumor response rate, time to progression, toxicity, quality of life;Primary end point(s): Progression of disease
- Secondary Outcome Measures
Name Time Method