RecruitingPhase 2NCT04161664
Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy
Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy (CRAVAT)
Sponsor
The Netherlands Cancer Institute
Enrollment
12 participants
Start Date
Jan 16, 2020
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria12
- 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 Criteria4
- 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
Interventions
DRUGPaclitaxel and Carboplatin
6 courses of Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04161664