RecruitingPhase 2NCT04161664

Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy

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


Sponsor

The Netherlands Cancer Institute

Enrollment

12 participants

Start Date

Jan 16, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing carboplatin and paclitaxel chemotherapy — a combination commonly used in other cancers — for women with metastatic (widely spread) vulvar cancer. Metastatic vulvar cancer is rare and has few standard treatment options; this trial aims to establish whether this chemotherapy combination is effective and well tolerated. **You may be eligible if...** - You are a woman 18 or older - You have histologically confirmed squamous cell vulvar carcinoma that has spread to distant organs (stage M1) - Your cancer is measurable on imaging - You have adequate blood, liver, and kidney function - You have a negative pregnancy test (if of childbearing age) - The tumor to be treated has not been previously irradiated **You may NOT be eligible if...** - Your vulvar cancer is not squamous cell type - You have previously had radiation to the vulva, groin, or pelvis - Your metastasis is limited to pelvic lymph nodes only and surgery with curative intent is still possible Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPaclitaxel and Carboplatin

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


Locations(1)

NKI-AVL

Amsterdam, Netherlands

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NCT04161664