Condition category
Cancer
Date applied
23/01/2006
Date assigned
15/05/2006
Last edited
15/05/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Matthias W. Beckmann

ORCID ID

Contact details

Universitaetsstr. 21-23
Erlangen
91054
Germany
+49 (0)9131 8533451
studienzentrale@gyn.imed.uni-erlangen.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IFG-01-0106

Study information

Scientific title

Acronym

AGO-Uterus-9

Study hypothesis

A chemotherapy scheme with topotecan and paclitaxel can be equally or more effective in advanced cervical cancer as a standard chemotherapy scheme

Ethics approval

Ethics approval details not yet received as of 15/05/2006

Study design

Prospective, two-armed, randomised clinical therapy trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Paclitaxel, topotecan, cisplatin

Primary outcome measures

Overall-survival

Secondary outcome measures

1. Time to progression
2. Efficacy
3. Therapy tolerance
4. Quality of life

Overall trial start date

01/02/2006

Overall trial end date

31/01/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

326

Participant exclusion criteria

Bilateral hydronephrosis, central nervous system (CNS)-metastases or reduced general condition

Recruitment start date

01/02/2006

Recruitment end date

31/01/2008

Locations

Countries of recruitment

Germany

Trial participating centre

Universitaetsstr. 21-23
Erlangen
91054
Germany

Sponsor information

Organisation

Institute for Women’s Health (Institut fuer Frauengesundheit GmbH) (Germany)

Sponsor details

Universitaetsstr. 21-23
Erlangen
91054
Germany
+49 (0)9131 8533508
studienzentrale@gyn.imed.uni-erlangen.de

Sponsor type

University/education

Website

http://www.ifg-erlangen.de

Funders

Funder type

Industry

Funder name

Institute for Women’s Health budget supported by GlaxoSmithKline GmbH & Co. KG Germany

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes