NCT05076942 · University Medical Center Groningen
Groningen International Study on Sentinel Nodes in Vulvar Cancer-III
(GROINSS-VIII)
What this study is about
Vulvar cancer patients with SN-metastasis \> 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.
View original scientific description
Vulvar cancer patients with SN-metastasis \> 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Histological confirmed primary SCC of the vulva
- T1 tumor, not encroaching urethra/vagina/anus
- Depth of invasion \> 1mm
- Tumor diameter \< 4cm
- Unifocal tumor
- No enlarged (\>1.5cm) 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
- Metastatic sentinel lymph node: more than 1 SN with metastasis ≤ 2mm
- Patients are able to understand requirements of study, provide written informed consent and comply with the study and follow-up procedures
- Adequate bone marrow, renal and liver function:
- Absolute neutrophil count ≥ 1.5 x 109 /L
- Platelet count ≥ 100 x 109 /L
- Creatinine clearance ≥ 40 ml/min measured by the Cockroft Gault formula
- Total bilirubin \< 1.25 x ULN Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN
- Performance status of 0, 1 or 2 on the Eastern Cooper
Where
- Orange, California
- Miami Beach, Florida
- Springfield, Massachusetts
- Grand Rapids, Michigan
- Traverse City, Michigan
- Omaha, Nebraska
- Las Vegas, Nevada
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
And 9 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 1, 2023 · Source of record for eligibility and locations