Chemo- and Radiotherapy in Epithelial Vulvar Cancer (CARE)

This study has been completed.
Sponsor:
Collaborators:
medac GmbH
Philipps University Marburg Medical Center
Information provided by (Responsible Party):
AGO Study Group
ClinicalTrials.gov Identifier:
NCT01304667
First received: February 24, 2011
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition
Radio/Chemotherapy in Node Positive Advanced Vulvar Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Chemo- and Radiotherapy in Epithelial Vulvar Cancer

Resource links provided by NLM:


Further study details as provided by AGO Study Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    • 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


Enrollment: 1618
Study Start Date: February 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304667

Locations
Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Sponsors and Collaborators
AGO Study Group
medac GmbH
Philipps University Marburg Medical Center
Investigators
Principal Investigator: Sven Mahner, MD PhD University Medical Center Hamburg-Eppendorf, Department of Gynecology
  More Information

No publications provided

Responsible Party: AGO Study Group
ClinicalTrials.gov Identifier: NCT01304667     History of Changes
Other Study ID Numbers: AGO-VOP.1 / CARE
Study First Received: February 24, 2011
Last Updated: June 24, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by AGO Study Group:
Vulvar cancer
Radiotherapy
Chemotherapy

Additional relevant MeSH terms:
Vulvar Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Vulvar Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 24, 2014