BridgeMD
New treatment option for Vulvar Cancer
Official title Groningen International Study on Sentinel Nodes in Vulvar Cancer-III
ClinicalTrials.gov ID: NCT05076942
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, given as an once-weekly, being studied as a potential treatment for vulvar cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Vulvar cancer patients with SN-metastasis \> 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Histological confirmed primary SCC of the vulva
- T1 tumor, not encroaching urethra/vagina/anus
- Depth of invasion \> 1mm
- Tumor diameter \< 4cm
- Unifocal tumor
You likely can't join if
- Inoperable tumors and tumors \> 4cm
- Multifocal tumors
- Tumors with other pathology 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 carcinomas, within last 5 years
- History of pelvic radiotherapy
See the full eligibility 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 Cooperative Oncology Group (ECOG) Scale (Appendix A)
- Age 18 years or older
- Life expectancy of ≥ 12 weeks
- Written informed consent
- Inoperable tumors and tumors \> 4cm
- Multifocal tumors
- Tumors with other pathology 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 carcinomas, within 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
- Desire to become pregnant
- Known brain or spinal cord metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids
- Unstable angina, myocardial infarction, cerebrovascular accident, \> Class II congestive heart failure according to the New York Heart Association Classification for Congestive Heart Failure (see Appendix B) within 6...
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- Miami Beach, Florida, United States
- Springfield, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Traverse City, Michigan, United States
- Omaha, Nebraska, United States
- Las Vegas, Nevada, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
- Durham, North Carolina, United States
- Raleigh, North Carolina, United States
- Columbus, Ohio, United States
- Sylvania, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Providence, Rhode Island, United States
+ 7 more site(s).
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 study runs about 5 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States; Miami Beach, Florida, United States; Springfield, Massachusetts, United States; Grand Rapids, Michigan, United States; Traverse City, Michigan, United States; Omaha, Nebraska, United States and 21 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.