Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy

  • STATUS
    Recruiting
  • End date
    Jan 1, 2029
  • participants needed
    12
  • sponsor
    The Netherlands Cancer Institute
Updated on 16 July 2021

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.

Description

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.

Details
Condition Metastatic Squamous Cell Carcinoma of the Vulva
Treatment Paclitaxel and Carboplatin
Clinical Study IdentifierNCT04161664
SponsorThe Netherlands Cancer Institute
Last Modified on16 July 2021

Eligibility

Yes No Not Sure

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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