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

Phase 2

Recruiting

• Conditions: Locally Advanced, Squamous Cell Carcinoma of the Vulva
• Interventions: Drug: Paclitaxel and Carboplatin

• Registration Number: NCT04192253
• Lead Sponsor: The Netherlands Cancer Institute

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-10
• Study Start: 2020-01-14
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-19
• Primary Completion: 2024-01-01
• Study Completion: 2029-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
neo-adjuvant Paclitaxel and Carboplatin	Paclitaxel and Carboplatin	Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule

Primary Outcome Measures

Name	Time	Method
tumour size change by neoadjuvant chemotherapy	18 weeks	tumour size change by neoadjuvant chemotherapy measured by RECIST 1.1

Secondary Outcome Measures

Name	Time	Method
Chemotherapy related morbidity	21 weeks	Chemotherapy related morbidity measured by reported adverse events
avoidance of exenterative or invalidating surgery	21 weeks	number of patients were surgery can be reduced after the neo-adjuvant chemotherapy
overall survival	5 years after treatment	overall survival

Trial Locations

Locations (1)

NKI-AVL; 🇳🇱 Amsterdam, Netherlands