Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT04192253

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

Led by The Netherlands Cancer Institute · Updated on 2022-10-19

51

Participants Needed

1

Research Sites

467 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Woman 18 years or older
  • Signed and written informed consent
  • Histologically confirmed squamous cell vulvar carcinoma
  • World Health Organization performance status of 0 to 2
  • Adequate hematological, hepatic, and renal function
  • Negative pregnancy test for women of childbearing potential
  • Measurable disease by physical examination
  • TNM stage T2, any N, M0
Not Eligible

You will not qualify if you...

  • Vulvar cancer other than squamous cell carcinoma at biopsy
  • Previous radiotherapy of the vulva, groins, or pelvis
  • Patients with metastasis limited to pelvic lymph nodes who can undergo primary curative surgery
  • Other diagnosis of malignancy or evidence of another malignancy within 5 years before screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

NKI-AVL

Amsterdam, Netherlands, 1066CX

Actively Recruiting

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Research Team

F

Frederic Amant, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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