Groningen International Study on Sentinel Nodes in Vulvar Cancer-III

Launched by UNIVERSITY MEDICAL CENTER GRONINGEN · Oct 1, 2021

Keywords

ClinConnect Summary

The Groningen International Study on Sentinel Nodes in Vulvar Cancer-III is a clinical trial focused on treating women with vulvar cancer who have certain types of lymph node involvement. Specifically, the study is looking at patients whose sentinel lymph nodes (the first nodes that cancer might spread to) have metastasis greater than 2mm. Instead of undergoing a surgical procedure called inguinofemoral lymphadenectomy, which involves removing the groin lymph nodes, these patients will receive chemoradiation, a combination of chemotherapy and radiation therapy.

To be eligible for the trial, participants must be adult women aged 18 and older with a confirmed diagnosis of squamous cell carcinoma of the vulva that meets specific criteria, such as having a tumor smaller than 4cm and not spreading to other areas like the urethra or vagina. They must also not have enlarged lymph nodes that appear suspicious on imaging tests. Participants can expect to receive treatment and be monitored closely for their health and response to the therapy. This trial aims to explore a less invasive treatment option that could improve outcomes for vulvar cancer patients.

Gender

FEMALE

Eligibility 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