Randomized phase III trial of paclitaxel plus topotecan versus topotecan plus cisplatin in recurrent or persistent cervical cancer stage IVb
| ISRCTN | ISRCTN77165120 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77165120 |
| Protocol serial number | IFG-01-0106 |
| Sponsor | Institute for Women’s Health (Institut fuer Frauengesundheit GmbH) (Germany) |
| Funder | Institute for Women’s Health budget supported by GlaxoSmithKline GmbH & Co. KG Germany |
- Submission date
- 23/01/2006
- Registration date
- 15/05/2006
- Last edited
- 15/05/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Matthias W. Beckmann
Scientific
Scientific
Universitaetsstr. 21-23
Erlangen
91054
Germany
| Phone | +49 (0)9131 8533451 |
|---|---|
| studienzentrale@gyn.imed.uni-erlangen.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, two-armed, randomised clinical therapy trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | AGO-Uterus-9 |
| Study objectives | A chemotherapy scheme with topotecan and paclitaxel can be equally or more effective in advanced cervical cancer as a standard chemotherapy scheme |
| Ethics approval(s) | Ethics approval details not yet received as of 15/05/2006 |
| Health condition(s) or problem(s) studied | Advanced carcinoma of the cervix uteri |
| Intervention | Patients are randomised to receive one of the following: 1. Paclitaxel and topotecan 2. Topotecan and cisplatin |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Paclitaxel, topotecan, cisplatin |
| Primary outcome measure(s) |
Overall-survival |
| Key secondary outcome measure(s) |
1. Time to progression |
| Completion date | 31/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 326 |
| Key inclusion criteria | Patients with progressive histologically confirmed carcinoma of the cervic uteri and measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST]) without treatment alternatives to chemotherapy |
| Key exclusion criteria | Bilateral hydronephrosis, central nervous system (CNS)-metastases or reduced general condition |
| Date of first enrolment | 01/02/2006 |
| Date of final enrolment | 31/01/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
Universitaetsstr. 21-23
Erlangen
91054
Germany
91054
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
