Chemotherapy treatment for advanced vulvar cancer
Official title: Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy (CRAVAT)
Run by The Netherlands Cancer Institute · NCT04161664 · Data updated 2026-11-12
This study is testing if a combination of chemotherapy drugs can help shrink tumors in women with advanced vulvar cancer before surgery, making the surgery easier and safer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 12 (estimated) |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Amsterdam) |
| Status | Recruiting |
| Started | January 16, 2020 |
| Main results expected | January 1, 2024 |
| Study ends | January 1, 2029 |
| Registry record updated | October 19, 2022 |
| Trial ID | NCT04161664 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 metastatic squamous cell vulvar carcinoma and adequate organ function.
✕Probably not a fit
Patients with vulvar cancer types other than squamous cell carcinoma or those who can undergo curative surgery without chemotherapy 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 carboplatin and paclitaxel chemotherapy in women with metastatic squamous cell carcinoma of the vulva. The goal is to downstage the tumor before surgery, potentially reducing the extent of surgical intervention and associated postoperative morbidity. Participants will receive these chemotherapy agents to shrink the tumor, making surgical treatment less invasive. The study focuses on women aged 18 and older with confirmed metastatic vulvar cancer who meet specific health criteria.
Why it matters
Potential benefit: If successful, this treatment could lead to less extensive surgeries and reduced postoperative complications for patients with advanced vulvar cancer.
How similar studies have gone: Other studies have shown promise in using neoadjuvant chemotherapy for similar cancers, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Woman 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 * Histologically or CT scan confirmed metastatic squamous cell vulvar carcinoma * Measurable disease * Lesion previously not irradiated * TNM stage any T any N M1 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.