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Study of Chemoradiation for Vulvar Cancer with Lymph Node Metastasis

This study is for women with early-stage vulvar cancer that has spread to the sentinel lymph node (the first lymph node to which cancer cells are likely to spread) with a metastasis larger than 2mm. The study is testing if a combination of radiotherapy (radiation treatment) and cisplatin (a chemotherapy drug) can be a safe and effective alternative to surgery (inguinofemoral lymphadenectomy) for removing these lymph nodes. Surgery can cause significant side effects like wound healing problems and swelling. The main goal is to see how many patients experience a recurrence of cancer in the groin area within the first two years after treatment. This study plans to enroll 157 participants, but its current status is unclear.

Study design
This is a Phase II treatment trial with stopping rules for groin recurrence, meaning it's designed to assess the safety and effectiveness of the intervention. It plans to enroll 157 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, groin recurrence rate, is measured within the first two years after primary treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05076942

Groningen International Study on Sentinel Nodes in Vulvar Cancer-III

Recruiting
PHASE2Ages 18+InterventionalTreatment
University Medical Center Groningen
~157 participants
Updated 2023-08-01 on ClinicalTrials.gov
What's tested:Radiotherapy combined with cisplatinCisplatin

At a glance

Recruiting sites
27 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Groin recurrence rate
Measured over Within first 2 years after primary treatment

Conditions

Vulvar Cancer
Sentinel Lymph Node
Lymph Node Metastases

Explore related trials

Vulvar Carcinoma

Where it's being run

27 sites across 14 states
Netherlands6
New York4
New Jersey3
Michigan2
North Carolina2
Ohio2
California1
Florida1

Who to contact

Maaike H Oonk, MD PhD
[email protected]
+31-50-3613000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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 months before enrollment

What this trial measures

  • Groin recurrence rateWithin first 2 years after primary treatment

    Groin recurrence in the groin with SN metastasis treated with chemoradiation