Primary chemoradiation versus neoadjuvant chemotherapy followed by surgery as treatment strategy for locally advanced vulvar carcinoma (VULCANize2)
- Conditions
- The trial population will consist of patients with LAVC who require primary chemoradiation orextensive surgery damaging pelvic organs or exenterative surgery.Therapeutic area: Diseases [C] - Neoplasms [C04]
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 98
Woman = 18 years, Beta HCG level of 14 mIU/mL or below for women of childbearing potential, Highly effective contraception for patients if the risk of conception exists, Highly effective contraception for patients if the risk of conception exists, Signed and written informed consent, Histologically-confirmed primary or recurrent squamous cell carcinoma vulvar cancer FIGO stage Ib – IVa, T1b or higher, any N, M0, Local tumour through which the size or localization implies requirement of treatment through primary chemoradiation or surgery consisting of extensive surgery (meaning surgery damaging pelvic organs or exenterative surgery). This can imply: T1b or larger tumour with (irresectable) groin metastases. Or this can imply: T1b or larger tumour with a close relationship to and/or involvement of the urethra or anal sphincter, World Health Organization performance status of 0-2, Adequate haematological function defined by platelet count >100x10E9/L, absolute neutrophil count >1.5x10E9/L, and hemoglobin >6.0 mmol/L, Adequate hepatic function defined by a total bilirubin level =1.5x the upper limit of normal range and ASAT and ALAT levels =2.5x ULN for all subjects, Adequate renal function defined by an estimated creatinine clearance =50mL/min according to the Cockroft-Gault formula (or local institutional standard method)
Patients with highly suspicious or positive metastases to the pelvic lymph nodes, Any psychiatric condition that would prohibit the understanding or rendering of informed consent, Prior radiotherapy to the pelvis or groin area limiting full dose chemoradiation according to protocol, Existing neuropathy which will hinder the intake of chemotherapy, Patients eligible for radical local excision without involvement of other organs
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of this trial is to compare the efficacy and safety of primary chemoradiation with<br>neoadjuvant chemotherapy (NACT) followed by surgery in patients with LAVC.;Secondary Objective: Secondary objectives of this trial are to compare the quality of life (QoL) of patients with LAVC after primary chemoradiation with patients treated with NACT followed by surgery., Determine the effect of human papillomavirus (HPV) status on treatment response.;Primary end point(s): The primary endpoint is loco-regional control at 2 years per arm, including salvage or adjuvant treatments
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Morbidity;Secondary end point(s):Disease-related treatment failure;Secondary end point(s):Disease-free survival;Secondary end point(s):Prevention of trimodal treatment (surgery and chemotherapy and radiotherapy);Secondary end point(s):functional organ preservation;Secondary end point(s):Quality of life;Secondary end point(s):Treatment-related morbidity;Secondary end point(s):death;Secondary end point(s):Complications;Secondary end point(s):Influence of HPV status on treatment outcome