NRG-GY024

Open to Accrual

Return to Protocol Table

Protocol Information

Tab containing protocol details, study design, and eligibility criteria
Tab containing study documents, informed consent forms, and study materials
Tab containing information for potential study participants

Groningen International Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) III: A Prospective Phase II Treatment Trial

Principal Investigator

Brian M. Slomovitz

Status

Open to Accrual

Date Opened To Accrual

August 31, 2021


Disease Site

Gynecologic [GY] Cervix

Phase

II

Developmental Therapeutics

No

Primary Objective

The primary objective of this study is to investigate the safety of replacing inguinofemoral lymphadenectomy by chemoradiation in early-stage vulvar cancer patients with a macrometastasis (>2mm) and/or extracapsular extension in the Sentinel Lymph Node (SLN). The secondary objective is to evaluate the short and long-term morbidity associated with the SLN procedure and chemoradiation.

Patient Population

Early stage vulvar cancer with macrometastasis and/or extracapsular extension in the SLN

Target Accrual

15

Patient Study Webpage

There is no available patient study webpage available for this trial at this time.