Locally Advanced, 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 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
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 ll trial to investigate the response rate of carboplatin and paclitaxel in patients with locally advanced vulvar carcinoma
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tumour size change by neoadjuvant chemotherapy | 18 weeks | tumour size change by neoadjuvant chemotherapy measured by RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| avoidance of exenterative or invalidating surgery | 21 weeks | number of patients were surgery can be reduced after the neo-adjuvant chemotherapy |
| Chemotherapy related morbidity | 21 weeks | Chemotherapy related morbidity measured by reported adverse events |
| overall survival | 5 years after treatment | overall survival |
Countries
Netherlands
Contacts
Primary ContactFrederic Amant, MD, PhD
Outcome results
None listed