Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Metastatic Squamous Cell Carcinoma of the Vulva

Intervention / Treatment
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* Drug: Paclitaxel and Carboplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: a prospective, phase II trial to investigate the response rate of carboplatin and paclitaxel in patients with vulvar carcinoma
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: neo adjuvant Paclitaxel and Carboplatin<br>6 courses of Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule | Drug: Paclitaxel and Carboplatin<br>* 6 courses of Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumour size reduction by neo adjuvant chemotherapy | tumour size reduction measured by RECIST 1.1 | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chemotherapy related morbidity | chemotherapy related morbidity measured by number and grade of adverse events | 21 weeks | 
| overall survival | overall survival | 5 years after treatment |