NCT01160185

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2009

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 8, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2010

Completed
Last Updated

July 12, 2010

Status Verified

July 1, 2010

Enrollment Period

1 month

First QC Date

July 8, 2010

Last Update Submit

July 8, 2010

Conditions

Cervical Intraepithelial Neoplasia

Outcome Measures

Primary Outcomes (1)

  • Survival

    12 months

Study Arms (3)

cisplatin

Drug: cisplatin

cisplatin + topotecan

Drug: cisplatinDrug: topotecan

cisplatin + paclitaxel

Drug: paclitaxelDrug: cisplatin

Interventions

paclitaxelDRUG

paclitacel

cisplatin + paclitaxel
cisplatinDRUG

cisplatin monotherapy

cisplatincisplatin + paclitaxelcisplatin + topotecan
topotecanDRUG

topotecan

cisplatin + topotecan

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

PaclitaxelCisplatinTopotecan

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 8, 2010

First Posted

July 12, 2010

Study Start

June 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

July 12, 2010

Record last verified: 2010-07