Chemotherapy treatment for advanced vulvar cancer
Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy (CRAVAT)
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 |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT04161664 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with histologically confirmed metastatic squamous cell vulvar carcinoma and adequate organ function.
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.
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 performed: Other studies have shown promise in using neoadjuvant chemotherapy for similar cancers, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Amsterdam
- Nki-Avl — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Frederic Amant, MD, PHD — NKI-AvL
- Study coordinator: Frederic Amant, MD, PhD
- Email: f.amant@nki.nl
- Phone: 0031205129111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.