Cervical Intraepithelial NeoplasiaNCT01160185
Meta-analysis of Efficacy of Topotecan
An observational study of Cervical Intraepithelial Neoplasia, run by GlaxoSmithKline.
Trial summary
This meta-analysis was conducted to investigate the efficacy of Topotecan and other treatments for recurrent and stage IVB carcinoma of the cervix Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- paclitaxel, cisplatin and topotecan
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None
About this study
Official title: Meta-analysis of Efficacy of Topotecan and Other Treatments for Recurrent Carcinoma of the Cervix
This meta-analysis was conducted to investigate the efficacy of Topotecan and other treatments for recurrent and stage IVB carcinoma of the cervix
Read the detailed description
Studies included in the meta-analysis were: GOG-0179, GOG-0204 \& GOG-0169
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- paclitaxel, cisplatin, topotecan
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxelDrug
paclitacel
cisplatinDrug
cisplatin monotherapy
topotecanDrug
topotecan
| Study group | Role | What they receive |
|---|---|---|
| cisplatin | Not described Receives: Drug: cisplatin | |
| cisplatin + topotecan | Not described Receives: Drug: cisplatin; Drug: topotecan | |
| cisplatin + paclitaxel | Not described Receives: Drug: paclitaxel; Drug: cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startJun 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160185
- Sponsor's protocol ID
- 114015
- Status last verified
- Jul 2010
- First submitted
- 8 Jul 2010
- Last updated
- 12 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meta-analysis of Efficacy of Topotecan and Other Treatments for Recurrent Carcinoma of the Cervix
- ClinicalTrials.gov ID
- NCT01160185
- Acronym / sponsor ID
- 114015
- Conditions
- Cervical Intraepithelial Neoplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 12 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cisplatin | – | Drug: cisplatin |
| cisplatin + topotecan | – | Drug: cisplatin, Drug: topotecan |
| cisplatin + paclitaxel | – | Drug: paclitaxel, Drug: cisplatin |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paclitaxelpaclitacel | Drug | cisplatin + paclitaxel |
| cisplatincisplatin monotherapy | Drug | cisplatin, cisplatin + paclitaxel, cisplatin + topotecan |
| topotecantopotecan | Drug | cisplatin + topotecan |
Primary outcome
Survival
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Intraepithelial Neoplasia, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2010.