advanced stage squamous cell cancer of the vulva MedDRA version: 8.1 Level: LLT Classification code 10047777 Term: Vulvar cancer
Conditions
Interventions
Trade Name: Xeloda
Pharmaceutical Form: Tablet
INN or Proposed INN: CAPECITABINE
Other descriptive name: CAPECITABINE
Sponsors
Koningin Wilhelmina Fonds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • squamous cell cancer of the vulva with locally advanced disease not curable with surgery unless extensive reconstructive surgery or a colostomy or urostomy is performed • Amenable to curative treatment • No disease present outside the pelvis • Performance status WHO 0-2 • Patients must be fit enough to undergo salvage surgery after chemo radiotherapy • Measurable disease at least locally (vulvar area) • Pretreatment laboratory values: - Hb> 6.5 mmol/l - Neutrophil count> 1.5 x 109/l - Platelets = 100 x 109/l - Bilirubin 18 years old • Written informed consent • No psychosis, CNS disease or other expected difficulty for follow-up • No active uncontrolled infection • No concomitant or previous malignancy other than basal cell carcinoma of the skin or CIN of the cervix Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to gain experience with primary radiochemotherapy and to determine the locoregional response rate at 12 weeks after radiochemotherapy and after groin dissection for cN1,2 patients.;Secondary Objective: The secondary objective would be to determine short-term morbidity defined as desquamation of the skin, infection, long-term morbidity defined as edema, fibrosis, the incidence of fecal and or urinary continence, and or incidence of reconstructive surgery performed and treatment related mortality. Longterm morbidity and the rate of locoregional recurrences will be evaluated at 24 months after the end of radiochemotherapy.;Primary end point(s): locoregional control rate defined as clinically or pathologically proven absence of tumor (CR according to RECIST criteria) in the vulvar area, groins and/or pelvis 12 weeks after the end of radiochemotherapy and after groin dissection in cN1,2 patients. | — |
Countries
Netherlands
Outcome results
None listed