RECRUITING

Groningen International Study on Sentinel Nodes in Vulvar Cancer-III

Talk to us

Conditions

Vulvar CancerSentinel Lymph NodeLymph Node Metastases

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2021-01-01
Study Completion:2029-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05076942

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histological confirmed primary SCC of the vulva
  2. * T1 tumor, not encroaching urethra/vagina/anus
  3. * Depth of invasion \> 1mm
  4. * Tumor diameter \< 4cm
  5. * Unifocal tumor
  6. * No enlarged (\>1.5cm) or suspicious inguinofemoral lymph nodes at imaging (CT/MRI/ultrasound)
  7. * Possibility to obtain informed consent
  8. * Metastatic sentinel lymph node; size of metastasis \> 2mm and / or extracapsular extension, or
  9. * Metastatic sentinel lymph node: more than 1 SN with metastasis ≤ 2mm
  10. * Patients are able to understand requirements of study, provide written informed consent and comply with the study and follow-up procedures
  11. * Adequate bone marrow, renal and liver function:
  12. * Absolute neutrophil count ≥ 1.5 x 109 /L
  13. * Platelet count ≥ 100 x 109 /L
  14. * Creatinine clearance ≥ 40 ml/min measured by the Cockroft Gault formula
  15. * Total bilirubin \< 1.25 x ULN Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN
  16. * Performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Scale (Appendix A)
  17. * Age 18 years or older
  18. * Life expectancy of ≥ 12 weeks
  19. * Written informed consent
  1. * Inoperable tumors and tumors \> 4cm
  2. * Multifocal tumors
  3. * Tumors with other pathology than squamous cell carcinoma
  4. * Patients with enlarged / suspicious lymph nodes which are proven metastatic after fine needle aspiration cytology
  5. * No other carcinomas, other than basal cell carcinomas, within last 5 years
  6. * History of pelvic radiotherapy
  7. * History of any infection requiring hospitalization or antibiotics within 2 weeks before enrollment
  8. * Pregnant female or nursing mother
  9. * Desire to become pregnant
  10. * Known brain or spinal cord metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids
  11. * 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

Contacts and Locations

Study Contact

Maaike H Oonk, MD PhD
CONTACT
+31-50-3613000
m.h.m.oonk@umcg.nl
Liza Lahaye
CONTACT
eventinbox@umcg.nl

Study Locations (Sites)

UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140
United States
Baystate Medical Center
Springfield, Massachusetts, 01199
United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503
United States
Munson Medical Center
Traverse City, Michigan, 49684
United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89106
United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Commack
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina, 27607
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Women and Infants Hospital
Providence, Rhode Island, 02905
United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
United States

Collaborators and Investigators

Sponsor: University Medical Center Groningen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-01
Study Completion Date2029-01-01

Study Record Updates

Study Start Date2021-01-01
Study Completion Date2029-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Vulvar Cancer
  • Sentinel Lymph Node
  • Lymph Node Metastases