Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Meta-analysis of Efficacy of Topotecan

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.
 
ClinicalTrials.gov Identifier: NCT01160185
Recruitment Status : Completed
First Posted : July 12, 2010
Last Update Posted : July 12, 2010
Sponsor:
Information provided by:
GlaxoSmithKline

Tracking Information
First Submitted Date July 8, 2010
First Posted Date July 12, 2010
Last Update Posted Date July 12, 2010
Study Start Date June 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 8, 2010)
Survival [ Time Frame: 12 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Meta-analysis of Efficacy of Topotecan
Official Title Meta-analysis of Efficacy of Topotecan and Other Treatments for Recurrent Carcinoma of the Cervix
Brief Summary This meta-analysis was conducted to investigate the efficacy of Topotecan and other treatments for recurrent and stage IVB carcinoma of the cervix
Detailed Description Studies included in the meta-analysis were: GOG-0179, GOG-0204 & GOG-0169
Study Type Observational
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-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 conducted on 18 December 2008.
Condition Cervical Intraepithelial Neoplasia
Intervention
  • Drug: paclitaxel
    paclitacel
  • Drug: cisplatin
    cisplatin monotherapy
  • Drug: topotecan
    topotecan
Study Groups/Cohorts
  • cisplatin
    Intervention: Drug: cisplatin
  • cisplatin + topotecan
    Interventions:
    • Drug: cisplatin
    • Drug: topotecan
  • cisplatin + paclitaxel
    Interventions:
    • Drug: paclitaxel
    • Drug: cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 8, 2010)
1
Original Actual Enrollment Same as current
Actual Study Completion Date July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Randomised Clinical Trials or systematic reviews or 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01160185
Other Study ID Numbers 114015
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Study Director, GSK
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date July 2010