Neoadjuvant chemotherapy for advanced vulvar cancer
Official title: Treatment of Locally Advanced VULvar CArcinoma in a Neoadjuvant Setting With Carboplatin and Paclitaxel Chemotherapy (VULCANize)
Run by The Netherlands Cancer Institute · NCT04192253 · Data updated 2026-11-12
This study tests if giving chemotherapy before surgery can help women with advanced vulvar cancer shrink their tumors and have easier surgeries.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 51 (estimated) |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Amsterdam) |
| Status | Recruiting |
| Started | January 14, 2020 |
| Main results expected | January 1, 2024 |
| Study ends | January 1, 2029 |
| Registry record updated | October 19, 2022 |
| Trial ID | NCT04192253 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 and older with histologically confirmed squamous cell vulvar carcinoma and specific health criteria.
✕Probably not a fit
Patients with vulvar cancer types other than squamous cell carcinoma or those who can be primarily operated on with curative intent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of neoadjuvant chemotherapy with Carboplatin and Paclitaxel in women with locally advanced squamous cell carcinoma of the vulva. The goal is to shrink the tumor before surgery, potentially allowing for less extensive surgical intervention and reducing postoperative complications. Participants must have histologically confirmed vulvar cancer and meet specific health criteria. The study aims to evaluate the effectiveness of this chemotherapy regimen in improving surgical outcomes.
Why it matters
Potential benefit: If successful, this approach could lead to reduced surgical morbidity and improved quality of life for patients with advanced vulvar cancer.
How similar studies have gone: Other studies have shown promise with neoadjuvant chemotherapy approaches in similar malignancies, suggesting potential for success in this context.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Nki-Avl
Amsterdam, Netherlands Recruiting
Study contacts
- Principal investigator: Frederic Amant, MD, PHD — The Netherlands Cancer Institute
- Study coordinator: Frederic Amant, MD, PhD
- Email: f.amant@nki.nl
- Phone: 0031205129111
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.