Last updated: 11/03/2018 16:01:57

Indirect comparison topotecan cervical carcinoma

GSK study ID
114016
See study documents
Clinicaltrials.gov ID
NCT01345279
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    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)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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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