Treatment of metastatic vulvar carcinoma in a neoadjuvant setting with Carboplatin and Paclitaxel chemotherapy

Phase 2

• Conditions: vulva carcinoma; 10038594

• Registration Number: NL-OMON49490
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

• 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
• Histologically or CT scan confirmed metastatic squamous cell vulvar carcinoma
• Measurable disease
• TNM stage any T any N M1

Exclusion Criteria

• Vulvar cancer other than squamous cell carcinoma at biopsy
• 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 neo adjuvant chemotherapy. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives are chemotherapy related morbidity will be monitored as<br /><br>well as be<br /><br>disease free and overall survival and patterns of recurrence.</p><br>