Treatment of locally advanced VULvar CArcinoma in a Neoadjuvant setting with Carboplatin and Paclitaxel chemotherapy
- Conditions
- 10038594vulvar carcinoma
- Registration Number
- NL-OMON48481
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 51
• Woman >= 18 years
• Signed and written informed consent.
• Histologically confirmed squamous cell vulvar carcinoma
• World Health Organization performance status of 0-2
• Adequate hematological function
• Adequate hepatic function
• Adequate renal function
• Negative pregnancy test for woman of childbearing potential
• measurable disease by physical examination
• TNM stage T2, any N, M0
• Vulvar cancer other than squamous cell carcinoma at biopsy
• Previous radiotherapy of the vulva, groins or pelvis
• Patients with metastasis limited to the pelvic lymph nodes, who can be
primarily operated with curative intent
• Other diagnosis of malignancy or evidence of other malignancy for 5 years
before screening for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>response rate and tumour size reduction by neoadjuvant chemotherapy. Morbidity<br /><br>and complication assessment </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objectives are the avoidance of exenterative or invalidating surgery.<br /><br>Chemotherapy related morbidity will be monitored as well as be disease free and<br /><br>overall survival and patterns of recurrence. </p><br>