← Landscape

Trial NCT05076942

Groningen International Study on Sentinel Nodes in Vulvar Cancer-III

Phase
Phase 2
Sponsor
University Medical Center Groningen
Conditions
Vulvar Cancer; Sentinel Lymph Node; Lymph Node Metastases
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

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 formulaRenal * Total bilirubin < 1.25 x ULN Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULNHepatic * Performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Scale (Appendix A)Performance status * 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 yearsPrior malignancy * History of pelvic radiotherapy * History of any infection requiring hospitalization or antibiotics within 2 weeks before enrollment * Pregnant female or nursing motherPregnancy * 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 steroidsBrain metastases * 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 enrollmentCardiac

Restrictions found (7)

Recruiting in Massachusetts

  • Baystate Medical Center · Springfield, Hampden County