No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
157 (estimated)
Sponsor
University Medical Center Groningen · Other
Who this trial is looking for
This trial is looking for women with vulvar cancer who have specific lymph node conditions. Participants will receive chemoradiation instead of surgery to remove lymph nodes.
Are You a Good Fit for This Trial?
Rules you outBrain metastasesSpinal cord metastasesUnstable anginaHeart attack in past 6 monthsSevere heart failure
You may be able to join if
I have been diagnosed with vulvar cancer.
My tumor is small and not affecting nearby organs.
My tumor is less than 4cm.
I have a single tumor.
I understand the study and can give my consent.
I have a lymph node with metastasis larger than 2mm.
I am at least 18 years old.
I have a life expectancy of at least 12 weeks.
You may not be able to join if
I have been told my tumor cannot be operated on.
My tumor is larger than 4cm.
I have multiple tumors.
I have a different type of cancer other than squamous cell carcinoma.
I have enlarged lymph nodes that are proven metastatic.
I have had pelvic radiotherapy before.
I was hospitalized for an infection or took antibiotics in the last 2 weeks.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Vulvar cancer patients with SN-metastasis \> 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.
Trial Locations
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Facility
City
State
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Status
Eligibility Criteria
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 …
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 Cooperative Oncology Group (ECOG) Scale (Appendix A)
* Age 18 years or older
* Life expectancy of ≥ 12 weeks
* Written informed consent
Exclusion Criteria:
* 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
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