NCT05076942 Groningen International Study on Sentinel Nodes in Vulvar Cancer-III
| NCT ID | NCT05076942 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Medical Center Groningen |
| Condition | Vulvar Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 157 participants |
| Start Date | 2021-01-01 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 157 participants in total. It began in 2021-01-01 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Vulvar cancer patients with SN-metastasis \> 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.
Eligibility Criteria
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 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05076942 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Vulvar Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05076942 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05076942 currently recruiting?
Yes, NCT05076942 is actively recruiting participants. Contact the research team at m.h.m.oonk@umcg.nl for enrollment information.
Where is the NCT05076942 trial being conducted?
This trial is being conducted at Orange, United States, Miami Beach, United States, Springfield, United States, Grand Rapids, United States and 11 additional locations.
Who is sponsoring the NCT05076942 clinical trial?
NCT05076942 is sponsored by University Medical Center Groningen. The trial plans to enroll 157 participants.
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