Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT04161664

Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy

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

12

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

CONDITIONS

Official Title

Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy

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 0-2
  • Adequate hematological function
  • Adequate hepatic function
  • Adequate renal function
  • Negative pregnancy test for women 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
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 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

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 Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy | DecenTrialz