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Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy

RecruitingPhase 2Ages 18 Years - anyFemaleThe Netherlands Cancer Institute
NCT04161664 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Paclitaxel and Carboplatin
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Where

1 site
NKI-AVL
Amsterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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