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Gronigen International Study on Sentinel Nodes in Vulvar Cancer: A Prospective Phase II

Krishnansu Tewari


A Study On:

  • Other Female Genital

Status:

  • Open

Eligibility

Sexes Eligible for Study: Female
18 Years and older (Adult, Older Adult)

Official Title

Gronigen International Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) III: A Prospective Phase II Treatment Trial

Details

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


Eligibility

You can join if...

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 greater than or equal to 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 greater than or equal to 1.5 x 109 /L
-Platelet count greater than or equal t 100 x 109 /L
-Creatinine clearancegreater than or equal to 40 ml/min measured by the Cockroft Gault formula
-Total bilirubin < 1.25 x ULN Aspartate transaminase (AST) and alanine transaminase (ALT) greater than or equal to 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 greater than or equal to12 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

Get in touch with our study team