Treatment of Locally Advanced VULvar CArcinoma in a Neoadjuvant Setting With Carboplatin and Paclitaxel Chemotherapy (VULCANize)
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- tumour size change by neoadjuvant chemotherapy
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
neo-adjuvant Paclitaxel and Carboplatin
Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule
Intervention: Paclitaxel and Carboplatin (Drug)
Outcomes
Primary Outcomes
tumour size change by neoadjuvant chemotherapy
Time Frame: 18 weeks
tumour size change by neoadjuvant chemotherapy measured by RECIST 1.1
Secondary Outcomes
- Chemotherapy related morbidity(21 weeks)
- avoidance of exenterative or invalidating surgery(21 weeks)
- overall survival(5 years after treatment)