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Chemoradiation for vulvar cancer patients with large sentinel node metastasis

Groningen International Study on Sentinel Nodes in Vulvar Cancer-III, a Prospective Phase II Treatment Trial

Phase 2 Interventional University Medical Center Groningen · NCT05076942

This study is testing if combining chemotherapy and radiation can be a safer and more effective treatment for women with early-stage vulvar cancer who have larger cancer spread in their lymph nodes, instead of having surgery.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment157 (estimated)
Ages18 Years and up
SexFemale
SponsorUniversity Medical Center Groningen Academic / other
Drugs / interventionschemotherapy
Locations27 sites (Orange, California and 26 other locations)
Trial IDNCT05076942 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of replacing inguinofemoral lymphadenectomy with chemoradiation in patients with early-stage vulvar cancer who have sentinel node metastasis greater than 2mm. The study aims to evaluate the potential benefits of combining radiotherapy with cisplatin chemotherapy to improve treatment outcomes while minimizing morbidity associated with traditional surgical approaches. Participants will be closely monitored for both short and long-term side effects related to the treatment. The trial is designed as a Phase II intervention with specific stopping rules for groin recurrences.

Who should consider this trial

Good fit: Ideal candidates are early-stage vulvar cancer patients with sentinel node metastasis greater than 2mm or multiple metastases less than or equal to 2mm.

Not a fit: Patients with smaller sentinel node metastases or those with extensive lymph node involvement may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce the need for invasive surgery and associated complications in vulvar cancer patients.

How similar studies have performed: Previous studies have shown promising results with radiotherapy as an alternative to surgery in similar patient populations, indicating potential for this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Orange, California and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Vulvar CancerSentinel Lymph NodeLymph Node Metastases
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.