Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy
NCT04161664 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2022-10-19
Summary
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.
Conditions
- Metastatic Squamous Cell Carcinoma of the Vulva
Interventions
- DRUG
-
Paclitaxel and Carboplatin
6 courses of Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule
Sponsors & Collaborators
-
The Netherlands Cancer Institute
lead OTHER
Principal Investigators
-
Frederic Amant, MD, PHD · NKI-AvL
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-01-16
- Primary Completion
- 2024-01-01
- Completion
- 2029-01-01
Countries
- Netherlands
Study Locations
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