Treatment of Locally Advanced VULvar CArcinoma in a Neoadjuvant Setting With Carboplatin and Paclitaxel Chemotherapy (VULCANize)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Paclitaxel and Carboplatin.
- Who it may be relevant to
- Registry conditions: Locally Advanced, Squamous Cell Carcinoma of the Vulva. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug Paclitaxel and Carboplatin
Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule
Primary outcome measures
- tumour size change by neoadjuvant chemotherapy [Time frame: 18 weeks]
Secondary outcome measures (3)
- avoidance of exenterative or invalidating surgery [Time frame: 21 weeks]
- Chemotherapy related morbidity [Time frame: 21 weeks]
- overall survival [Time frame: 5 years after treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- NKI-AVL — Amsterdam
Identifiers
NCT: NCT04192253 · M19VLC