Groningen International Study on Sentinel Nodes in Vulvar Cancer-III

Description

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

Conditions

Vulvar Cancer, Sentinel Lymph Node, Lymph Node Metastases

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Study Overview

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Study Details

Study overview

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

Groningen International Study on Sentinel Nodes in Vulvar Cancer-III, a Prospective Phase II Treatment Trial

Groningen International Study on Sentinel Nodes in Vulvar Cancer-III

Condition
Vulvar Cancer
Intervention / Treatment

-

Contacts and Locations

Orange

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States, 92868

Miami Beach

Mount Sinai Medical Center, Miami Beach, Florida, United States, 33140

Springfield

Baystate Medical Center, Springfield, Massachusetts, United States, 01199

Grand Rapids

Spectrum Health at Butterworth Campus, Grand Rapids, Michigan, United States, 49503

Traverse City

Munson Medical Center, Traverse City, Michigan, United States, 49684

Omaha

Nebraska Methodist Hospital, Omaha, Nebraska, United States, 68114

Las Vegas

Women's Cancer Center of Nevada, Las Vegas, Nevada, United States, 89106

Basking Ridge

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States, 07920

Middletown

Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States, 07748

Montvale

Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States, 07645

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University Medical Center Groningen,

Study Record Dates

2029-01-01