RecruitingPhase 2NCT04192253

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


Sponsor

The Netherlands Cancer Institute

Enrollment

51 participants

Start Date

Jan 14, 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 neoadjuvant 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 whether chemotherapy (carboplatin and paclitaxel) given before surgery can shrink locally advanced vulvar cancer enough to allow for less extensive surgery and better outcomes. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with squamous cell vulvar cancer confirmed by biopsy - Your cancer is at stage T2 without distant spread - Your general health status is good enough to tolerate treatment (WHO performance status 0–2) - Your blood, liver, and kidney functions are adequate - You have a negative pregnancy test if you could become pregnant **You may NOT be eligible if...** - Your vulvar cancer is a type other than squamous cell carcinoma - You have had radiation therapy to the vulva, groin, or pelvis before - Your cancer has spread only to pelvic lymph nodes and surgery with curative intent is still possible - You have had another cancer in the past 5 years 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

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


Locations(1)

NKI-AVL

Amsterdam, Netherlands

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NCT04192253