Treatment of Locally Advanced VULvar CArcinoma in a Neoadjuvant Setting With Carboplatin and Paclitaxel Chemotherapy (VULCANize)

• Status: Recruiting
• Trial end date: 2029-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

Vulvar cancer is a rare malignancy. Surgery is the treatment of choice, but frequently causes invalidating and chronic postoperative morbidity, especially in patients with high stage disease. Theoretically, downstaging with neoadjuvant chemotherapy could shrink the tumour, making surgical treatment less extensive thereby diminishing the chance for morbidity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Netherlands Cancer Institute
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Woman k 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, MO

Exclusion Criteria:

• 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