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Indirect Comparison Topotecan Cervical Carcinoma

Indirect Comparison of the Efficacy Between Topotecan and Other Treatments for Recurrent Carcinoma of the Cervix

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01345279
Enrollment
1
Registered
2011-05-02
Start date
2009-06-30
Completion date
2009-07-31
Last updated
2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Intraepithelial Neoplasia

Brief summary

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.

Interventions

DRUGcisplatin

50 mg/m2 IV cisplatin on day 1 and then every 3 weeks for 6 courses

DRUGtopotecan

topotecan 0.75 mg/m2 on days 1, 2, and 3. The regimen was repeated every 3 weeks for 6 courses

DRUGpaclitaxel

135 mg/m2 paclitaxel on day 1 and then every 3 weeks for 6 courses

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Overall survival12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026