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 |
| Secondary identifying numbers | IFG-01-0106 |
- 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
| Study design | Prospective, two-armed, randomised clinical therapy trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Paclitaxel, topotecan, cisplatin |
| Primary outcome measure | Overall-survival |
| Secondary outcome measures | 1. Time to progression 2. Efficacy 3. Therapy tolerance 4. Quality of life |
| Overall study start date | 01/02/2006 |
| Completion date | 31/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
Sponsor information
Institute for Women’s Health (Institut fuer Frauengesundheit GmbH) (Germany)
University/education
University/education
Universitaetsstr. 21-23
Erlangen
91054
Germany
| Phone | +49 (0)9131 8533508 |
|---|---|
| studienzentrale@gyn.imed.uni-erlangen.de | |
| Website | http://www.ifg-erlangen.de |
"ROR" |
https://ror.org/01f30wv40 |
Funders
Funder type
Industry
Institute for Women’s Health budget supported by GlaxoSmithKline GmbH & Co. KG Germany
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
