Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy

Recruiting now · Phase 2

Conditions studied: Metastatic Squamous Cell Carcinoma of the Vulva

In brief

Vulvar cancer is a rare malignancy. Surgery is the treatment of choice, but frequently causes invalidating and chronic postoperative morbidity, especially in patients with high stage disease. Theoretically, downstaging with neo adjuvant chemotherapy could shrink the tumour, making surgical treatment less extensive thereby diminishing the chance for morbidity.

Key facts

Study ID

NCT04161664

Run by

The Netherlands Cancer Institute

People needed

12

Starts

2020-01-16

Expected to finish

2029-01-01

Last updated by the study team

2022-10-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• NKI-AVL — Amsterdam, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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