RecruitingPhase 2NCT05076942
Groningen International Study on Sentinel Nodes in Vulvar Cancer-III
Groningen International Study on Sentinel Nodes in Vulvar Cancer-III, a Prospective Phase II Treatment Trial
Sponsor
University Medical Center Groningen
Enrollment
157 participants
Start Date
Jan 1, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
Vulvar cancer patients with SN-metastasis \> 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria19
- 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 Criteria11
- 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
Interventions
RADIATIONRadiotherapy combined with cisplatin
Inguinofemoral radiotherapy combined with weekly cisplatin
DRUGCisplatin
Inguinofemoral radiotherapy combined with weekly cisplatin
Locations(27)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05076942
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