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

Locally Advanced, Squamous Cell Carcinoma of the Vulva Clinical Trial

— VULCANize  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04192253
• Other study ID #: M19VLC
• Status: Recruiting
• Phase: Phase 2
• Start date: January 14, 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 neoadjuvant 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 neoadjuvant chemotherapy could shrink the tumour, making surgical treatment less extensive, thereby diminishing the chance for morbidity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• 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 k 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
• measurable disease by physical examination
• TNM stage T2, any N, MO

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
• Locally Advanced, Squamous Cell Carcinoma of the Vulva
• Vulvar Neoplasms

Intervention

Drug:
• Paclitaxel and Carboplatin
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 change by neoadjuvant chemotherapy	tumour size change by neoadjuvant chemotherapy measured by RECIST 1.1	18 weeks
Secondary	avoidance of exenterative or invalidating surgery	number of patients were surgery can be reduced after the neo-adjuvant chemotherapy	21 weeks
Secondary	Chemotherapy related morbidity	Chemotherapy related morbidity measured by reported adverse events	21 weeks
Secondary	overall survival	overall survival	5 years after treatment