NRG-GY024 (Vulvar Cancer) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if radiation and chemotherapy can be done instead of an extensive surgical removal of the groin lymph nodes for patients with vulvar cancer whose disease has spread to the sentinel node. We are doing this study because we want to find out if this approach is better or worse than the usual approach for vulvar cancer.

What is the Condition Being Studied?

Early Stage Vulvar Cancer

Who Can Participate in the Study?

Adult females ages 18+ who:
- Are diagnosed with primary squamous cell carcinoma of the vulva
- Have a T1 tumor that is not encroaching the urethra, vagina, or anus
- Have no enlarged or suspicious lymph nodes found by imaging (CT/MRI/ultrasound)

For more information about who can join this study, please contact the study team at nick.jeffries@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Be treated with a higher dose of radiation than what is typically given after surgery
- Receive chemotherapy drugs (cisplatin/carboplatin) once a week during radiation treatment

The radiation + chemotherapy treatment will last for 5 weeks.

After your treatment is finished, you will visit our clinic for check-ups every 3 months for 2 years.

Study Details

Full Title
NRG-GY024: Groningen International Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) III: A Prospective Phase II Treatment Trial.
Principal Investigator
Radiation Oncologist
Protocol Number
IRB: PRO00109439
NCT: NCT05076942
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698