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Indirect Comparison Topotecan Cervical Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01345279
Recruitment Status : Completed
First Posted : May 2, 2011
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Cervical Intraepithelial Neoplasia Drug: cisplatin Drug: topotecan Drug: paclitaxel

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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Indirect Comparison of the Efficacy Between Topotecan and Other Treatments for Recurrent Carcinoma of the Cervix
Study Start Date : June 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Group/Cohort Intervention/treatment
cisplatin Drug: cisplatin
50 mg/m2 IV cisplatin on day 1 and then every 3 weeks for 6 courses

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

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

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

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

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The search was designed to identify all clinical data published since the Cancer Care Ontario systematic review in 2006. The Cancer Care Ontario systematic review searched MEDLINE (1966 to February 2006), EMBASE (1980 to February 2006), the Cochrane Library (Cochrane Database of Systematic Reviews (2006 Issue 1), and Cochrane Controlled Trials Register (2006 Issue 1)), the Canadian Medical Association Infobase, and the National Guidelines Clearinghouse. The conference proceedings of the American Society of Clinical Oncology (1995-2005) and the European Society of Medical Oncology (2002-2005) were also searched. The search was completed on 18 December 2008

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01345279

Sponsors and Collaborators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline Identifier: NCT01345279    
Other Study ID Numbers: 114016
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Cervical Intraepithelial Neoplasia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma in Situ
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors