Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy
Recruiting
Phase 2
Interventional Study
Metastatic Squamous Cell Carcinoma of the Vulva
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 12 (estimated)
- Sponsor
- The Netherlands Cancer Institute · Other
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About This Trial
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.
Trial Locations
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Eligibility 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 te…
Contacts