Treatment of metastatic vulvar carcinoma in a neoadjuvant setting with Carboplatin and Paclitaxel chemotherapy

Phase 1

• Conditions: vulvar carcinoma; MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: HLTClassification code 10047750Term: Vulval neoplasms malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-000851-15-NL
• Lead Sponsor: KI-AV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-27
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified