Last updated: 11/03/2018 16:01:57
Indirect comparison topotecan cervical carcinoma
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Indirect Comparison of the efficacy between topotecan and other treatments for recurrent carcinoma of the cervix
Trial description: Indirect comparisons were performed using data from GOG-0179 versus GOG-0169 to permit comparison of topotecan in combination with cisplatin versus cisplatin plus paclitaxel via the common comparator of cisplatin monotherapy. Both GOG-0179 and GOG-0169 were conducted in patients with stage IVB, recurrent or persistent carcinoma of the cervix, but there were some differences between the respective study populations. Patients with prior chemotherapy were eligible for GOG-0179 but ineligible for GOG-0169 (except when chemotherapy was used for radiation sensitisation). Fewer patients had received chemotherapy as a radiosensitiser in GOG-0169 (27%) than in GOG-0179 (~60%) and these patients were unevenly distributed between treatment arms in GOG-0169. In addition, the proportion of patients receiving cisplatin as a radiosensitiser in GOG-0169 is unknown. For these reasons, there are limitations associated with the indirect meta-analysis.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Overall survival
Timeframe: 12 months
Secondary outcomes:
Not applicable
Interventions:
Drug: cisplatin
Drug: topotecan
Drug: paclitaxel
Enrollment:
1
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Cervical Intraepithelial Neoplasia
Product
topotecan
Collaborators
Not applicable
Study date(s)
June 2009 to July 2009
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
21+ years
Accepts healthy volunteers
No
- randomised clinical trials, or systematic reviews and meta-analyses
- treatment with topotecan or platinum-based single and combination regimens in female patients of any race with cancer of the cervix recurrent after radiotherapy or stage IVB disease
- None
Inclusion and exclusion criteria
Inclusion criteria:
- randomised clinical trials, or systematic reviews and meta-analyses
- treatment with topotecan or platinum-based single and combination regimens in female patients of any race with cancer of the cervix recurrent after radiotherapy or stage IVB disease
Exclusion criteria:
- None
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2009-08-07
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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