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

Completed

Conditions

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

Observational

Enrollment (Actual)

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

Ages Eligible for Study

16 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

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

AGO Study Group

Collaborators

Philipps University Marburg Medical Center
medac GmbH

Investigators

  • 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

February 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

February 24, 2011

First Submitted That Met QC Criteria

February 24, 2011

First Posted (Estimate)

February 25, 2011

Study Record Updates

Last Update Posted (Estimate)

May 10, 2016

Last Update Submitted That Met QC Criteria

May 9, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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