Chemo- and Radiotherapy in Epithelial Vulvar Cancer (CARE)

May 9, 2016 updated by: AGO Study Group
This retrospective, multicenter study is designed to collect tumor characteristics as well as treatment data from patients diagnosed with primary or recurrent squamous cell cancer of the vulva with emphasis on indication and application of radio- and chemotherapy. Application of chemotherapy in primary treatment of vulvar cancer is rare; the study collective is therefore extended to relapsed disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

All patients with primary squamous cell cancer of the vulva > stage Ia who were diagnosed and received treatment between 1998 and 2008 at the participating centres will be included in the study. Furthermore patients with recurrent disease diagnosed and treated at the participating centres during the same time period can be included given that they not only underwent surgical excision for treatment.

For centers with restricted resources for data entry an alternative study collective was defined:

All Patients with primary or relapsed squamous cell vulvar cancer receiving radio- and/or chemotherapy for treatment at the participating centres between 1998 and 2008 will be included in the study. This also includes node negative patients receiving radio/chemotherapy for other reasons.

The participating centers themselves have to decide which study collective they are documenting, dependent on their available resources.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1618

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany
        • University Medical Center Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

This retrospective, multicenter study is designed to collect tumor characteristics as well as treatment data from patients diagnosed with primary or recurrent squamous cell cancer of the vulva with emphasis on indication and application of radio- and chemotherapy

Description

Inclusion Criteria:

  1. Patients with primary squamous cell vulvar cancer except stage Ia disease regardless of the received treatment
  2. Patients with recurrent squamous cell vulvar cancer, if the relapse was not only treated with a surgical excision.

  3. Or alternatively, dependent on the decision of the participating center:

    -Patients with primary or relapsed squamous cell vulvar cancer receiving radio- and/or chemotherapy for treatment regardless of nodal involvement.

  4. Patients who were diagnosed with and treated for primary or relapsed vulvar cancer between 1998 and 2008
  5. Women aged ≥ 18 years

Exclusion Criteria:

  1. Patients with benign or precursor lesions (VIN - vulvar intraepithelial neoplasia) of the vulva
  2. Patients with non-squamous neoplasia of the vulva (e.g. melanoma)
  3. Patients with verrucous vulvar cancer
  4. Patients with relapsed squamous cell vulvar cancer only receiving surgical excision for treatment.
  5. Patients with secondary cancers if those interfered with the treatment of vulvar disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Determination of several specific characteristics
Time Frame: Data from vulvar cancer pts between 1998 and 2008 will be included in the study. This also includes node negative patients receiving radi
  • Determination of the fraction of node positive patients to estimate the number of participating centers and sample size for a subsequent prospective trial.
  • Determination of the prognostic impact of the number of positive lymph nodes and the stage of disease to define indication criteria for adjuvant radio/chemotherapy for a subsequent prospective trial.
  • Identification of indication criteria for adjuvant/therapeutic/palliative radio/chemotherapy
Data from vulvar cancer pts between 1998 and 2008 will be included in the study. This also includes node negative patients receiving radi

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AGO Study Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Philipps University Marburg Medical Center
medac GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sven Mahner, MD PhD, University Medical Center Hamburg-Eppendorf, Department of Gynecology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AGO-VOP.1 / CARE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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