Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For LAVC

Inclusion Criteria:

• Woman ≥ 18 years
• Signed and written informed consent.
• Histologically-confirmed primary or recurrent squamous cell carcinoma vulvar cancerFIGO stage Ib - IVa, T1b or higher, any N, M0.
• Local tumour through which the size or localization implies requirement of treatmentthrough primary chemoradiation or surgery consisting of extensive surgery (meaningsurgery damaging pelvic organs or exenterative surgery). This can imply;
• T1b or larger tumour with (irresectable) groin metastases
• T1b or larger tumour with a close relationship to and/or involvement of theurethra or anal sphincter
• World Health Organization performance status of 0-2
• Adequate haematological function defined by platelet count >100x10E9/L, absoluteleukocyte >3X10E9/L or neutrophil count (ANC) >1.5x10E9/L, and hemoglobin >6.0 mmol/L
• Adequate hepatic function defined by a total bilirubin level ≤1.5x the upper limit ofnormal (ULN) range and ASAT and ALAT levels ≤2.5x ULN for all subjects
• Adequate renal function defined by an estimated creatinine clearance ≥50mL/minaccording to the Cockroft-Gault formula (or local institutional standard method)
• 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

Exclusion Criteria:

• Patients with highly suspicious or positive metastases to the pelvic lymph nodes

• Patients eligible for radical local excision without involvement of other organs

• Any psychiatric condition that would prohibit the understanding or rendering ofinformed consent
• Prior radiotherapy to the pelvis or groin area limiting full dose chemoradiationaccording to protocol
• Existing neuropathy which will hinder the intake of chemotherapy