Treatment of Metastatic Vulvar Carcinoma With Carboplatin and Paclitaxel Chemotherapy

Metastatic Squamous Cell Carcinoma of the Vulva Clinical Trial

— CRAVAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04161664
• Other study ID #: M19CVT
• Status: Recruiting
• Phase: Phase 2
• Start date: January 16, 2020
• Est. completion date: January 1, 2029

Study information

• Verified date: October 2022
• Source: The Netherlands Cancer Institute
• Contact: Frederic Amant, MD, PhD
• Phone: 0031205129111
• Email: f.amant[@]nki.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: January 1, 2029
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Metastatic Squamous Cell Carcinoma of the Vulva
• Vulvar Neoplasms

Intervention

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

Locations

Country	Name	City	State
Netherlands	NKI-AVL	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumour size reduction by neo adjuvant chemotherapy	tumour size reduction measured by RECIST 1.1	18 weeks
Secondary	chemotherapy related morbidity	chemotherapy related morbidity measured by number and grade of adverse events	21 weeks
Secondary	overall survival	overall survival	5 years after treatment