NCT04192253

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Locally Advanced, Squamous Cell Carcinoma of the Vulva

Interventions

Type	Name	Description
DRUG	Paclitaxel and Carboplatin	Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule

Timeline

• Start date: 2020-01-14
• Primary completion: 2024-01-01
• Completion: 2029-01-01
• First posted: 2019-12-10
• Last updated: 2022-10-19

Locations

1 site across 1 country: Netherlands