NRG-GY024 (Vulvar Cancer)

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.

Who Can Participate?

Eligibility

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 Range

18-110

Sex/Genders

Female (cisgender)
Transgender male
Looking for Healthy Participants
No

What is Involved?

Description

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.

Locations

Duke University Hospital
Duke Raleigh Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

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

Diandra
Ayala-Peacock

Protocol Number

PRO00109439

NCT ID

NCT05076942

Phase

II

Enrollment Status

Open to Enrollment
ClinicalTrials.gov