Indirect Comparison Topotecan Cervical Carcinoma

NCT ID: NCT01345279

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Intraepithelial Neoplasia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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cisplatin

cisplatin

Intervention Type DRUG

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

cisplatin + topotecan

cisplatin

Intervention Type DRUG

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

topotecan

Intervention Type DRUG

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

cisplatin + paclitaxel

cisplatin

Intervention Type DRUG

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

paclitaxel

Intervention Type DRUG

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

Interventions

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cisplatin

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

Intervention Type DRUG

topotecan

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

Intervention Type DRUG

paclitaxel

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

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114016

Identifier Type: -

Identifier Source: org_study_id

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