Indirect Comparison Topotecan Cervical Carcinoma

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Cervical Intraepithelial Neoplasia

Treatments: Drug: cisplatin; Drug: paclitaxel; Drug: topotecan

Study type: Observational

Funder types: Industry

Identifiers

NCT01345279

114016

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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 design

1 participants in 3 patient groups

cisplatin

Treatment:

Drug: cisplatin

cisplatin + topotecan

Treatment:

Drug: cisplatin

Drug: topotecan

cisplatin + paclitaxel

Treatment:

Drug: paclitaxel

Drug: cisplatin