Treatment of Locally Advanced VULvar CArcinoma in a Neoadjuvant Setting With Carboplatin and Paclitaxel Chemotherapy (VULCANize)
Recruiting
Phase 2
Interventional Study
Locally Advanced, 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
- 51 (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 neoadjuvant 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 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 …
Contacts