Indirect Comparison Topotecan Cervical Carcinoma

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Cervical intraepithelial neoplasia
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Brief Title

Indirect Comparison Topotecan Cervical Carcinoma

Official Title

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

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.

Study Type

Observational

Primary Outcome

Overall survival

Condition

Cervical Intraepithelial Neoplasia

Intervention

cisplatin

Study Arms / Comparison Groups

 cisplatin
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

1

Start Date

June 2009

Completion Date

July 2009

Primary Completion Date

July 2009

Eligibility 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

Gender

Female

Ages

21 Years - N/A

Accepts Healthy Volunteers

No

Contacts

GSK Clinical Trials, ,

Administrative Informations

NCT ID

NCT01345279

Organization ID

114016

Responsible Party

Sponsor

Study Sponsor

GlaxoSmithKline

Study Sponsor

GSK Clinical Trials, Study Director, GlaxoSmithKline

Verification Date

May 2017