Groningen International Study on Sentinel Nodes in Vulvar Cancer-III

• Status: Recruiting
• Trial end date: 2029-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

Vulvar cancer patients with SN-metastasis > 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Collaborator: Dutch Cancer Society
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• Histological confirmed primary 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 (CT/MRI/ultrasound)

• Possibility to obtain informed consent

• Metastatic sentinel lymph node; size of metastasis > 2mm and / or extracapsular extension, or

• 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

• Adequate bone marrow, renal and liver function:

• Absolute neutrophil count ≥ 1.5 x 109 /L

• Platelet count ≥ 100 x 109 /L

• Creatinine clearance ≥ 40 ml/min measured by the Cockroft Gault formula

• Total bilirubin < 1.25 x 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) Scale (Appendix A)

• Age 18 years or older

• Life expectancy of ≥ 12 weeks

• Written informed consent

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 (see Appendix B) within 6 months before enrollment