Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy (CRAVAT)

Netherlands Cancer Institute (NKI)

Status and phase: Enrolling; Phase 2

Conditions: Metastatic Squamous Cell Carcinoma of the Vulva

Treatments: Drug: Paclitaxel and Carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT04161664

M19CVT

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

neo adjuvant Paclitaxel and Carboplatin

Experimental group

Description:

6 courses of Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule

Treatment:

Drug: Paclitaxel and Carboplatin