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Primary chemoradiation versus neoadjuvant chemotherapy followed by surgery as treatment strategy for locally advanced vulvar carcinoma (VULCANize2)

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502685-25-00
Enrollment
111
Registered
2023-08-10
Start date
2024-01-01
Completion date
Unknown
Last updated
2025-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The trial population will consist of patients with LAVC who require primary chemoradiation or extensive surgery damaging pelvic organs or exenterative surgery.

Brief summary

The primary endpoint is loco‐regional control at 2 years per arm, including salvage or adjuvant treatments

Detailed description

Morbidity, Disease-related treatment failure, Disease-free survival, Prevention of trimodal treatment (surgery and chemotherapy and radiotherapy), functional organ preservation, Quality of life, Treatment-related morbidity, death, Complications, Influence of HPV status on treatment outcome

Interventions

DRUGCISPLATIN
DRUGCARBOPLATIN
DRUGPACLITAXEL

Sponsors

Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is loco‐regional control at 2 years per arm, including salvage or adjuvant treatments

Secondary

MeasureTime frame
Morbidity, Disease-related treatment failure, Disease-free survival, Prevention of trimodal treatment (surgery and chemotherapy and radiotherapy), functional organ preservation, Quality of life, Treatment-related morbidity, death, Complications, Influence of HPV status on treatment outcome

Countries

Belgium, Czechia, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026