Vulvar field resection trial
Not Applicable
Recruiting
- Conditions
- C51Malignant neoplasm of vulva
- Registration Number
- DRKS00013358
- Lead Sponsor
- niversitätsklinikum Leipzig
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 250
Inclusion Criteria
Vulvar carcinoma staged oT1-oT3b, Provision of written informed consent to participate in the trial
Exclusion Criteria
Compromised general condition (Karnovsky index <80),
Comorbidity which is not compatible with the operation,
Distant metastases
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of complications and sequelae of treatment according to the scale mild-moderate-severe-lethal during the immediate post-operative period and 3 months postoperatively. This includes photographic documentation of the reconstructive results. Thereafter, patients are regularly followed up by their gynecologists.<br>Recurrence-free and disease-specific survival are assessed by contacting all study participants or their gynecologists at regular interval. If no information on the survival status of the patient is available, the national or regional cancer registries are contacted for further information. The follow-up period is not limited.<br>
- Secondary Outcome Measures
Name Time Method Histopathological tumor assessment with regard to ontogenetic anatomy is performed post-operatively. Quality of life and psychological sequelae of VFR are assessed pre-operatively as well as 3 and 12 months postoperatively using the EORTC-QOL-30 (general quality of life assessment in cancer patients), GAD7 (general anxiety disorder scale), PHQ9 (9 items from the patients health questionnaire” regarding depressive symptoms), a Vulva module (ideally EORTC once validated). The presence of lymph edema is assessed at the specified time points using the gynecologic cancer lymph edema questionnaire (GCLQ). Overall survival is assessed analogous to recurrence-free and disease-specific survival as outlined above.