Chemoradiation for Vulvar Cancer with Lymph Node Metastasis

Groningen International Study on Sentinel Nodes in Vulvar Cancer-III

Recruiting Phase 2 Interventional Study
Vulvar Cancer Sentinel Lymph Node Lymph Node Metastases
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 out Brain 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.

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Answer a few quick questions to see if you may meet the eligibility requirements.

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About This Trial

Vulvar cancer patients with SN-metastasis \> 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.

Trial Locations
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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 …
Contacts

Maaike H Oonk, MD PhD

+31-50-3613000

m.h.m.oonk@umcg.nl

CONTACT

Liza Lahaye

eventinbox@umcg.nl

CONTACT