Chemo- and Radiotherapy in Epithelial Vulvar Cancer (CARE)
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.
Radio/Chemotherapy in Node Positive Advanced Vulvar Cancer
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Chemo- and Radiotherapy in Epithelial Vulvar Cancer|
- 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
|Study Start Date:||February 2011|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01304667
|University Medical Center Hamburg-Eppendorf|
|Principal Investigator:||Sven Mahner, MD PhD||University Medical Center Hamburg-Eppendorf, Department of Gynecology|