Clinical trial · Interventional
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
NCT05076942CI-TRIAL-00068416GROINSS-VIIIrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Vulvar cancer patients with SN-metastasis \> 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymph Node Metastases | — | UNRESOLVED | — |
| Sentinel Lymph Node | — | UNRESOLVED | — |
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Radiotherapy combined with cisplatin | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemoradiation
- description
- Inguinofemoral radiotherapy (48-50 Gy in 1.8 Gy daily fractions, with a boost dose to the involved inguinal site for a total equivalent dose of 56 Gy over 5-6 weeks, preferably with simultaneous integrated boost technique) combined with weekly cisplatin 40 mg/m2 intravenously on days 1, 8, 15, 22 and 29
- interventionNames
- Radiation: Radiotherapy combined with cisplatin
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Groin recurrence rate
- timeFrame
- Within first 2 years after primary treatment
- description
- Groin recurrence in the groin with SN metastasis treated with chemoradiation
Secondary outcomes (3)
- measure
- Treatment related morbidity
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGien LT, Slomovitz B, Van der Zee A, Oonk M. Phase II activity trial of high-dose radiation and chemosensitization in patients with macrometastatic lymph node spread after sentinel node biopsy in vulvar cancer: GROningen INternational Study on Sentinel nodes in Vulvar cancer III (GROINSS-V III/NRG-GY024). Int J Gynecol Cancer. 2023 Apr 3;33(4):619-622. doi: 10.1136/ijgc-2022-004122. PMID 36653060