Last reviewed · How we verify
NCT05905315: VULCANIZE-II
Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For LAVC
Phase 2 trial testing Paclitaxel and Carboplatin in Locally Advanced Vulvar Carcinoma in 98 participants. Currently enrolling.
1 September 2029
Quick facts
| Lead sponsor | The Netherlands Cancer Institute |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 98 |
| Start date | 1 January 2024 |
| Primary completion | 1 September 2029 |
| Estimated completion | 1 September 2029 |
| Sites | 2 locations across Netherlands |
Drugs / interventions tested
- Paclitaxel and Carboplatin — full drug profile →
- Chemoradiation — full drug profile →
Conditions studied
- Locally Advanced Vulvar Carcinoma — all drugs for Locally Advanced Vulvar Carcinoma →
- Squamous Cell Carcinoma of the Vulva — all drugs for Squamous Cell Carcinoma of the Vulva →
Sponsor
The Netherlands Cancer Institute
Who can join
18 and older, female only, with Locally Advanced Vulvar Carcinoma or Squamous Cell Carcinoma of the Vulva. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Primary chemoradiation versus neoadjuvant chemotherapy followed by surgery as treatment strategy for locally advanced vulvar carcinoma (VULCANize2).
Amant F, van Velzen AF, Reyners A, Zijlmans H, et al · · 2024 · cited 2× · PMID 38719277 · DOI 10.1136/ijgc-2024-005493
Verify or expand the search:
- PubMed search for NCT05905315
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Paclitaxel and Carboplatin
Trials testing the same drug.
- NCT04161664 — Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy · Phase 2 · recruiting
- NCT04192253 — Treatment of Locally Advanced VULvar CArcinoma in a Neoadjuvant Setting With Carboplatin and Paclitaxel Chemotherapy (VU · Phase 2 · recruiting
Other The Netherlands Cancer Institute trials
Trials by the same sponsor.
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- NCT07071727 — Short Course of Radiotherapy Prior to Surgery of Soft Tissue Sarcomas · NA · recruiting
- NCT06931769 — TAO-Towards Optimal (Neo)Adjuvant Systemic Therapy of Stage III Triple-negative Breast Cancer · recruiting
- NCT06273800 — Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients · NA · recruiting
- NCT07310758 — Contrast-enhanced Ultrasound for Sentinel Node Detection · Phase 2, PHASE3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05905315 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Netherlands Cancer Institute
- Last refreshed: 15 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05905315.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing