NRG GY024
Trial Overview
Official Title
Groningen International Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) III: A Prospective Phase II Treatment Trial
Study Purpose
To investigate the safety of replacing inguinofemoral lymphadenectomy by chemoradiation in early stage vulvar cancer patients with a macrometastasis and/or extracapsular extension in the SN.
Diagnosis
Early-stage vulvar cancer patients with a metastasis >2, in their SN.Eligibility
Early-stage vulvar cancer patients with a metastasis >2, in their SN
SCC of vulva, post-surgery.
T1 (not encroaching urethra/vagina/anus, depth of invasion >1mm, tumor <4cm).
No enlarged or suspicious inguinofemoral LN on imaging.
At time of surgery, SLNs: SLN mets >2mm and/or with ECE; OR >1 SLN w/micromets.
Patients must sign an approved informed consent and authorization permitting release of personal health information.
Intervention
Patients will be treated with chemoradiation combined with weekly cisplatin.
For more information, visit Clinicaltrials.gov