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:<ul>
<li>Are diagnosed with primary squamous cell carcinoma of the vulva</li>
<li>Have a T1 tumor that is not encroaching the urethra, vagina, or anus</li>
<li>Have no enlarged or suspicious lymph nodes found by imaging (CT/MRI/ultrasound)</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: nick.jeffries@duke.edu">nick.jeffries@duke.edu.</a>
<li>Are diagnosed with primary squamous cell carcinoma of the vulva</li>
<li>Have a T1 tumor that is not encroaching the urethra, vagina, or anus</li>
<li>Have no enlarged or suspicious lymph nodes found by imaging (CT/MRI/ultrasound)</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: nick.jeffries@duke.edu">nick.jeffries@duke.edu.</a>
Age Range
18-110
Sex/Genders
Female (cisgender)
Transgender male
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study, you will:<ul>
<li>Be treated with a higher dose of radiation than what is typically given after surgery</li>
<li>Receive chemotherapy drugs (cisplatin/carboplatin) once a week during radiation treatment</li></ul>
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.
<li>Be treated with a higher dose of radiation than what is typically given after surgery</li>
<li>Receive chemotherapy drugs (cisplatin/carboplatin) once a week during radiation treatment</li></ul>
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