Chemo- and Radiotherapy in Epithelial Vulvar Cancer (CARE)
|ClinicalTrials.gov Identifier: NCT01304667|
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : May 10, 2016
|Condition or disease|
|Radio/Chemotherapy in Node Positive Advanced Vulvar Cancer|
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|
|Actual Enrollment :||1618 participants|
|Official Title:||Chemo- and Radiotherapy in Epithelial Vulvar Cancer|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
- 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
Biospecimen Retention: Samples Without DNA
Subproject of Translational Research:
Paraffin embedded tissue samples were collected.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304667
|University Medical Center Hamburg-Eppendorf|
|Principal Investigator:||Sven Mahner, MD PhD||University Medical Center Hamburg-Eppendorf, Department of Gynecology|