GRONINGEN INTERNATIONAL STUDY ON SENTINEL NODES IN VULVAR CANCER III, A PROSPECTIVE PHASE II TREATMENT TRIAL

Investigating Chemoradiation (Combination of Chemotherapy and Radiation Therapy) for Early Stage Vulvar Cancer

S
Sharon E. Robertson

Primary Investigator

Recruiting
18 years - 100 years
Female
Phase 2
2 Locations

Brief description of study

The primary objective of this study is to investigate the safety of replacing inguinofemoral lymphadenectomy by chemoradiation in early stage vulvar cancer patients with a macrometastasis (>2mm) and/or extracapsular extension in the SN. The secondary objective is to evaluate the short and long-term morbidity associated with the SN procedure and chemoradiation.
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

Participants will be treated with chemoradiation, in a total dose of 56Gy to the involved site, combined with weekly cisplatin 40mg/m2 for 5 weeks.
 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Vulvar Cancer, Sentinel Lymph Node, Lymph Node Metastases
  • Age: 18 years - 100 years
  • Gender: Female

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

This study investigates the safety of using chemoradiation instead of surgery for early stage vulvar cancer. Vulvar cancer is a type of cancer that affects the external female genitalia. In some cases, cancer spreads to nearby lymph nodes. This study looks at patients with a macrometastasis, which means the cancer has spread to the lymph nodes and is larger than 2 millimeters, or has spread beyond the lymph node capsule.

Participants will receive a specific treatment involving chemoradiation. This means they will have radiation therapy, with a total dose of 56Gy directed at the cancer site. They will also receive a medicine called cisplatin once a week for 5 weeks. Cisplatin is a type of chemotherapy, which is a treatment that uses strong medicines to kill cancer cells.

  • Who can participate: Adults aged 18 and older with confirmed primary squamous cell carcinoma of the vulva and a tumor smaller than 4cm may participate. Participants must not have any enlarged lymph nodes on imaging and should be able to give informed consent.
  • Study details: Participants will undergo chemoradiation, which includes receiving radiation therapy and a chemotherapy medicine called cisplatin. Cisplatin is a type of chemotherapy, which is a treatment that uses strong medicines to kill cancer cells. Cisplatin is given weekly for 5 weeks. It is important for participants to follow the study procedures as instructed.
Updated on 23 Sep 2025. Study ID: CTO-NRG-GY024

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