BridgeMD
GROINSS-V III
EU CTIS ID: 2023-508722-99-00
What this study is testing
To investigate the safety of replacing inguinofemoral lymphadenectomy (with or without adjuvant (chemo)radiation) by chemoradiation alone in early-stage vulvar cancer patients with a macrometastasis (> 2mm) in the sentinel lymph node
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- histological confirmed primary squamous cell carcinoma of the vulva
- performance status of 0, 1, or 2 on the ECOG Scale
- Age 18 years or older
- Life expectancy of more than 12 weeks
- unifocal T1 tumor with a diamater < 4cm
- No enlarged or suspicious inguinofemoral lymph nodes at imaging (CT/MRI/ultrasound)
You likely can't join if
- inoperable tumors and tumors > 4cm
- multifocal tumors
- tumors with other histology than squamous cell carcinoma
- patients with enlarged / suspicious lymph nodes which are proven metastatic after fine needle aspiration cytology
- no other carcinomas, other than basal cell carcinoma, within the last 5 years
- history of pelvic radiotherapy
See the full eligibility criteria
- histological confirmed primary squamous cell carcinoma of the vulva
- performance status of 0, 1, or 2 on the ECOG Scale
- Age 18 years or older
- Life expectancy of more than 12 weeks
- unifocal T1 tumor with a diamater < 4cm
- No enlarged or suspicious inguinofemoral lymph nodes at imaging (CT/MRI/ultrasound)
- possibility to obtain informed consent
- metastatic sentinel lymph node: size of metastasis > 2mm and / or extracapsular extension, or more than 1 sentinel node with a metastasis </= 2mm
- patients are able to understand requirements of study and comply with the study and follow-up procedures
- adequate bone marrow, renal and liver function
- inoperable tumors and tumors > 4cm
- multifocal tumors
- tumors with other histology than squamous cell carcinoma
- patients with enlarged / suspicious lymph nodes which are proven metastatic after fine needle aspiration cytology
- no other carcinomas, other than basal cell carcinoma, within the last 5 years
- history of pelvic radiotherapy
- history of any infection requiring hospitalization or antibiotics within 2 weeks before enrollment
- pregnant female or nursing mother
- unstable angina, myocardial infarction, cerebrovascular accident, > class II congestive heart failure according to the NY Heart Association Classification of Congestive Heart Failure within 6 months before enrollment
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.