Chemoradiation for vulvar cancer patients with large sentinel node metastasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and efficacy of replacing inguinofemoral lymphadenectomy with chemoradiation in patients with early-stage vulvar cancer who have sentinel node metastasis greater than 2mm. The study aims to evaluate the potential benefits of combining radiotherapy with cisplatin chemotherapy to improve treatment outcomes while minimizing morbidity associated with traditional surgical approaches. Participants will be closely monitored for both short and long-term side effects related to the treatment. The trial is designed as a Phase II intervention with specific stopping rules for groin recurrences.

Why it matters

Who can join: the full rules

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

Where it's running

• UC Irvine Health/Chao Family Comprehensive Cancer Center
  Orange, California, United States Recruiting
• Mount Sinai Medical Center
  Miami Beach, Florida, United States Recruiting
• Baystate Medical Center
  Springfield, Massachusetts, United States Recruiting
• Spectrum Health at Butterworth Campus
  Grand Rapids, Michigan, United States Recruiting
• Munson Medical Center
  Traverse City, Michigan, United States Recruiting
• Nebraska Methodist Hospital
  Omaha, Nebraska, United States Recruiting

Study contacts

• Study coordinator: Maaike H Oonk, MD PhD
• Email: m.h.m.oonk@umcg.nl
• Phone: +31-50-3613000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using optical guidance for sentinel node biopsy in vulvar cancer

  This study is testing if using a special dye can help doctors find lymph nodes in women with early-stage vulvar cancer, to see if it makes the procedure easier and more accurate.

  Recruiting Copenhagen University Hospital, Rigshospitalet · Copenhagen · NCT06029504

• Targeted Axillary Dissection for Early-stage Breast Cancer

  This study tests a new surgery method for early-stage breast cancer to see if using a special seed to find and remove positive lymph nodes works better than traditional methods.

  Recruiting at 3 sites Jewish General Hospital · Montreal, Quebec and 2 other locations · NCT04671511

• Examining the impact of small-volume lymph node disease in endometrial and cervical cancer

  This study is trying to see how small amounts of cancer in lymph nodes affect treatment choices and outcomes for people with early-stage endometrial and cervical cancer.

  Recruiting Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Milan · NCT04403867

• Methylation markers in self-samples to help detect gynecological cancers

  This study tests whether self-collected urine and vaginal samples can reveal DNA methylation or other genetic markers that indicate endometrial, ovarian, vulvar, or vaginal cancers in women who are at risk or have postmenopausal bleeding.

  Recruiting Universiteit Antwerpen · Edegem, Antwerp · NCT07902375

• Radiotherapy for gynecologic cancer with up to 10 metastatic sites

  This registry follows adults with gynecologic cancer who have 1 to 10 active metastatic lesions and are treated with radiotherapy as part of routine care to see how such treatments work in real-world settings.

  Recruiting Affidea Nu-med Center of Oncological DIagnostics and Therapy · Zamość · NCT07883798

• Using indocyanine green to find sentinel lymph nodes during mastectomy

  This pilot will test whether injecting indocyanine green and using fluorescence during mastectomy can find sentinel lymph nodes in women with clinically node-negative invasive breast cancer.

  Recruiting at 2 sites St. Antonius Hospital · Zwolle, Overijssel and 1 other locations · NCT07362485

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.