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
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)
- Brain metastasesConditionalexclusionShow in the text
- CardiacConditionalexclusion
NYHA > Class II; MI within 6 months
Show in the text - HepaticOutrightinclusion
bilirubin < 1.25 x ULN; AST/ALT ≤ 2.5 x ULN
Show in the text - Performance statusOutrightinclusion
ECOG 0-2
Show in the text - PregnancyOutrightexclusionShow in the text
- Prior malignancyOutrightexclusion
within 5 years
Show in the text - RenalOutrightinclusion
CrCl ≥ 40 ml/min
Show in the text
Recruiting in Massachusetts
- Baystate Medical Center · Springfield, Hampden County