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

University Medical Center Groningen

Summary

Vulvar cancer patients with SN-metastasis \> 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.

Description

Rationale: Standard treatment of early stage vulvar cancer is a wide local excision of the primary tumor combined with the sentinel node (SN) procedure for the groins. An inguinofemoral lymphadenectomy (IFL) is only indicated in case of a positive SN. An IFL is associated with major morbidity, e.g. wound healing problems, lymphoceles, lymphedema of the legs and recurrent infections. GROINSS-V II investigated whether radiotherapy would be a safe alternative for IFL in case of SN metastasis. The results for radiotherapy in the group with metastasis ≤ 2mm are promising. This study also showed th…

Eligibility

Age range: 18+ years
Sex: Female
Healthy volunteers: No

Detailed 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 th…

Interventions

Radiation
Radiotherapy combined with cisplatin
Inguinofemoral radiotherapy combined with weekly cisplatin
Drug
Cisplatin
Inguinofemoral radiotherapy combined with weekly cisplatin

Locations (27)

UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California
Mount Sinai Medical Center
Miami Beach, Florida
Baystate Medical Center
Springfield, Massachusetts
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan
Munson Medical Center
Traverse City, Michigan
Nebraska Methodist Hospital
Omaha, Nebraska