Treatment of Locally Advanced VULvar CArcinoma in a Neoadjuvant Setting With Carboplatin and Paclitaxel Chemotherapy (VULCANize)

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 neoadjuvant 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 neoadjuvant chemotherapy could shrink the tumour, making surgical treatment less extensive, thereby diminishing the chance for morbidity.

Official Title
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Treatment of Locally Advanced VULvar CArcinoma in a Neoadjuvant Setting With Carboplatin and Paclitaxel Chemotherapy (VULCANize)

Conditions
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Locally Advanced, 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 k 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 measurable disease by physical examination TNM stage T2, any N, MO 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 ll trial to investigate the response rate of carboplatin and paclitaxel in patients with locally advanced vulvar carcinoma
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: neo-adjuvant Paclitaxel and Carboplatin<br>Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule | Drug: Paclitaxel and Carboplatin<br>* 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 change by neoadjuvant chemotherapy | tumour size change by neoadjuvant chemotherapy measured by RECIST 1.1 | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| avoidance of exenterative or invalidating surgery | number of patients were surgery can be reduced after the neo-adjuvant chemotherapy | 21 weeks | 
| Chemotherapy related morbidity | Chemotherapy related morbidity measured by reported adverse events | 21 weeks | 
| overall survival | overall survival | 5 years after treatment |