NCT05905315

Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For LAVC

Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For Locally Advanced Vulvar Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase 2 randomised controlled trial will be performed in which the efficacy and safety of standard treatment (primary chemoradiation; consisting of 64.5 Gy in 30 fractions of external beam radiotherapy with weekly cisplatin for six weeks) and experimental treatment (NACT; consisting of carboplatin and paclitaxel in a 3-weekly scheme) will be compared in 98 patients with LAVC, registered from eight national medical centres.

Conditions

• Locally Advanced Vulvar Carcinoma
• Squamous Cell Carcinoma of the Vulva

Interventions

Type	Name	Description
DRUG	Paclitaxel and Carboplatin	Paclitaxel 175 mg/m2, followed by carboplatin 5 area under the curve (AUC). This will be administered in a 3-weekly scheme.
COMBINATION_PRODUCT	Chemoradiation	According to standard treatment.

Timeline

• Start date: 2024-01-01
• Primary completion: 2029-09-01
• Completion: 2029-09-01
• First posted: 2023-06-15
• Last updated: 2024-04-15

Locations

2 sites across 1 country: Netherlands