Groningen International Study on Sentinel Nodes in Vulvar Cancer-III

Recruiting now · Phase 2

Conditions studied: Vulvar Cancer, Sentinel Lymph Node, Lymph Node Metastases

In brief

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

Key facts

Study ID

NCT05076942

Run by

University Medical Center Groningen

People needed

157

Starts

2021-01-01

Expected to finish

2029-01-01

Last updated by the study team

2023-08-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States (enrolling)
• Mount Sinai Medical Center — Miami Beach, Florida, United States (enrolling)
• Baystate Medical Center — Springfield, Massachusetts, United States (enrolling)
• Spectrum Health at Butterworth Campus — Grand Rapids, Michigan, United States (enrolling)
• Munson Medical Center — Traverse City, Michigan, United States (enrolling)
• Nebraska Methodist Hospital — Omaha, Nebraska, United States (enrolling)
• Women's Cancer Center of Nevada — Las Vegas, Nevada, United States (enrolling)
• Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Commack — Commack, New York, United States (enrolling)
• Memorial Sloan Kettering Westchester — Harrison, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Nassau — Uniondale, New York, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• Duke Women's Cancer Care Raleigh — Raleigh, North Carolina, United States (enrolling)
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (enrolling)
• ProMedica Flower Hospital — Sylvania, Ohio, United States (enrolling)
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (enrolling)
• Women and Infants Hospital — Providence, Rhode Island, United States (enrolling)
• Avera Cancer Institute — Sioux Falls, South Dakota, United States (enrolling)
• Catharina Hospital Eindhoven — Eindhoven, Netherlands (enrolling)
• University Medical Center Groningen — Groningen, Netherlands (enrolling)
• Leiden University Medical Center — Leiden, Netherlands (enrolling)
• Radboud University Medical Center — Nijmegen, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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