Testing the Treatment of Radiation and Cisplatin Chemotherapy for Patients with Disease which Has Spread and Been Detected in the Sentinel Nodes in Surgically Resected Vulvar Cancer, (GROINSS-V) III Trial

Inclusion Criteria

• Histological confirmed primary squamous cell carcinoma (SCC) of the vulva
• T1 tumor, not encroaching urethra/vagina/anus
• Depth of invasion > 1mm
• Tumor diameter < 4cm
• Unifocal tumor
• No enlarged (> 1.5cm) or suspicious inguinofemoral lymph nodes at imaging (computed tomography [CT]/magnetic resonance imaging [MRI]/ultrasound)
• Possibility to obtain informed consent
• Metastatic sentinel lymph node; size of metastasis > 2mm and / or extracapsular extension
• Metastatic sentinel lymph node: more than 1 SN with metastasis =< 2mm
• Patients are able to understand requirements of study, provide written informed consent and comply with the study and follow-up procedures
• Absolute neutrophil count >= 1.5 x 10^9 /L
• Platelet count >= 100 x 10^9 /L
• Creatinine clearance >= 40 ml/min measured by the Cockroft-Gault formula
• Total bilirubin < 1.25 x upper limit of normal (ULN)
• Aspartate transaminase (AST) and alanine transaminase (ALT) =< 2.5 x ULN
• Performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG)
• Age 18 years or older
• Life expectancy of >= 12 weeks
• Written informed consent
• CANADIAN PATIENTS: Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a women over age 45 in the absence of other biological or physiological causes
• CANADIAN PATIENTS: Willing to use highly effective contraceptives for participants of childbearing potential (participants who may become pregnant) during therapy. Highly effective contraception is defined as hormonal contraceptives (oral contraceptives, Nuvaring, Depo Provera), intrauterine device, true abstinence, two barrier methods of birth control including condoms with cervical cap or diaphragm

Exclusion Criteria

• Inoperable tumors and tumors > 4cm
• Multifocal tumors
• Tumors with other pathology than squamous cell carcinoma
• Patients with enlarged / suspicious lymph nodes which are proven metastatic after fine needle aspiration cytology
• No other carcinomas, other than basal cell carcinomas, within last 5 years
• History of pelvic radiotherapy
• History of any infection requiring hospitalization or antibiotics within 2 weeks before enrollment
• Pregnant female or nursing mother
• Desire to become pregnant
• Known brain or spinal cord metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids
• Unstable angina, myocardial infarction, cerebrovascular accident, > class II congestive heart failure according to the New York Heart Association Classification for Congestive Heart Failure within 6 months before enrollment