EUCTR2019-000851-15-NLActive, not recruitingPhase 1
Treatment of metastatic vulvar carcinoma in a neoadjuvant setting with Carboplatin and Paclitaxel chemotherapy - CRAVAT
KI-AV0 sites12 target enrollmentStarted: November 27, 2019Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 12
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
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 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
- •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
Investigators
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