Efficacy of staging by sentinel lymph node procedure in vulvar cancer.
Recruiting
- Conditions
- Vulvar cancer.
- Registration Number
- NL-OMON29393
- Lead Sponsor
- Dept. Gynecologic Oncology University Hospital GroningenP.O. Box 300019700 RB GroningenThe NetherlandsTel: 050 - 361 61 61
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 400
Inclusion Criteria
1. Patients with histologically proven T1 or T2 (FIGO) tumor <4 cm and not reaching urethra, vagina or anus with clinically negative inguinofemoral lymphnodes;
2. Injection of radio-isotope is possible;
Exclusion Criteria
1. Inoperable tumors and tumors >4 cm;
2. Patient with chemically suspect lymph nodes or cytologically proven lymphnode metastases;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Outcome and relapse rates in two year follow-up.
- Secondary Outcome Measures
Name Time Method Morbidity of the procedure and safety of frozen section multiple sectioning and immunohistochemistry in detecting lymphnode metastases.