Groningen International Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) III: A Prospective Phase II Treatment Trial
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.
DiagnosisEarly-stage vulvar cancer patients with a metastasis >2, in their SN.
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.
Patients will be treated with chemoradiation combined with weekly cisplatin.
For more information, visit Clinicaltrials.gov