RecruitingPhase 2NCT05076942

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

Sponsor

University Medical Center Groningen

Enrollment

157 participants

Start Date

Jan 1, 2021

Study Type

INTERVENTIONAL

Conditions

Sentinel Lymph Node Lymph Node Metastases Vulvar Cancer

Summary

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

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying the best way to treat the groin lymph nodes in people with vulvar cancer who have a small amount of cancer found in their sentinel lymph node (the first lymph node the cancer could spread to). **You may be eligible if...** - You are 18 or older with confirmed squamous cell carcinoma of the vulva - Your tumor is smaller than 4 cm, localized to one spot, and not involving the urethra, vagina, or anus - A sentinel lymph node biopsy found either a metastasis larger than 2 mm, extracapsular spread, or more than one positive lymph node - Your blood counts and organ function are within acceptable ranges - Your life expectancy is at least 12 weeks **You may NOT be eligible if...** - Your tumor is larger than 4 cm or involves multiple spots - You have known metastatic lymph nodes (proven by needle biopsy) - You have had pelvic radiation before - You have had another cancer (other than basal cell skin cancer) in the last 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiotherapy combined with cisplatin

Inguinofemoral radiotherapy combined with weekly cisplatin

DRUGCisplatin

Inguinofemoral radiotherapy combined with weekly cisplatin

Locations(27)

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

Baystate Medical Center

Springfield, Massachusetts, United States

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, United States

Munson Medical Center

Traverse City, Michigan, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Women's Cancer Center of Nevada

Las Vegas, Nevada, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Duke Women's Cancer Care Raleigh

Raleigh, North Carolina, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

ProMedica Flower Hospital

Sylvania, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Women and Infants Hospital

Providence, Rhode Island, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Catharina Hospital Eindhoven

Eindhoven, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Leiden University Medical Center

Leiden, Netherlands

Radboud University Medical Center

Nijmegen, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

University Medical Center Utrecht

Utrecht, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05076942

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