Metastatic Squamous Cell Carcinoma of the Vulva
Conditions
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 neo adjuvant 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 neo adjuvant chemotherapy could shrink the tumour, making surgical treatment less extensive thereby diminishing the chance for morbidity.
Interventions
6 courses of Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule
Sponsors
The Netherlands Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
a prospective, phase II trial to investigate the response rate of carboplatin and paclitaxel in patients with vulvar carcinoma
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tumour size reduction by neo adjuvant chemotherapy | 18 weeks | tumour size reduction measured by RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| chemotherapy related morbidity | 21 weeks | chemotherapy related morbidity measured by number and grade of adverse events |
| overall survival | 5 years after treatment | overall survival |
Countries
Netherlands
Contacts
Primary ContactFrederic Amant, MD, PhD
Outcome results
None listed