Actively Recruiting
Groningen International Study on Sentinel Nodes in Vulvar Cancer-III
Led by University Medical Center Groningen · Updated on 2023-08-01
157
Participants Needed
27
Research Sites
417 weeks
Total Duration
On this page
Sponsors
U
University Medical Center Groningen
Lead Sponsor
D
Dutch Cancer Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
Vulvar cancer patients with SN-metastasis \> 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.
CONDITIONS
Official Title
Groningen International Study on Sentinel Nodes in Vulvar Cancer-III
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed primary squamous cell carcinoma of the vulva
- Tumor classified as T1, not involving urethra, vagina, or anus
- Depth of tumor invasion greater than 1 mm
- Tumor diameter less than 4 cm
- Unifocal tumor
- No enlarged or suspicious inguinofemoral lymph nodes on imaging (CT, MRI, or ultrasound)
- Ability to provide informed consent
- Sentinel lymph node metastasis larger than 2 mm and/or extracapsular extension, or more than one sentinel lymph node with metastasis 2 mm or smaller
- Ability to understand study requirements and comply with procedures
- Adequate bone marrow function (absolute neutrophil count ≥ 1.5 x 10^9/L)
- Adequate platelet count (≥ 100 x 10^9/L)
- Adequate kidney function (creatinine clearance ≥ 40 ml/min)
- Liver enzymes within defined limits (bilirubin < 1.25 x upper limit of normal; AST and ALT ≤ 2.5 x upper limit of normal)
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Age 18 years or older
- Life expectancy of at least 12 weeks
- Written informed consent
You will not qualify if you...
- Inoperable tumors or tumors larger than 4 cm
- Multifocal tumors
- Tumors with histology other than squamous cell carcinoma
- Enlarged or suspicious lymph nodes proven metastatic by fine needle aspiration
- History of other carcinomas (except basal cell carcinoma) within 5 years
- Prior pelvic radiotherapy
- Infection requiring hospitalization or antibiotics within 2 weeks before enrollment
- Pregnancy or nursing
- Desire to become pregnant
- Known brain or spinal cord metastases unless treated and stable without progression
- Unstable angina, recent myocardial infarction, stroke, or congestive heart failure class greater than II within 6 months before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
2
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Actively Recruiting
3
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Actively Recruiting
4
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
5
Munson Medical Center
Traverse City, Michigan, United States, 49684
Actively Recruiting
6
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
Actively Recruiting
7
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89106
Actively Recruiting
8
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
9
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
10
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
11
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
12
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
13
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
14
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
15
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
16
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina, United States, 27607
Actively Recruiting
17
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
18
ProMedica Flower Hospital
Sylvania, Ohio, United States, 43560
Actively Recruiting
19
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
20
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
Actively Recruiting
21
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
22
Catharina Hospital Eindhoven
Eindhoven, Netherlands, 5623EJ
Actively Recruiting
23
University Medical Center Groningen
Groningen, Netherlands, 9712RB
Actively Recruiting
24
Leiden University Medical Center
Leiden, Netherlands, 2333ZA
Actively Recruiting
25
Radboud University Medical Center
Nijmegen, Netherlands, 6525GA
Actively Recruiting
26
Erasmus Medical Center
Rotterdam, Netherlands, 3015GD
Actively Recruiting
27
University Medical Center Utrecht
Utrecht, Netherlands, 3584CX
Actively Recruiting
Research Team
M
Maaike H Oonk, MD PhD
CONTACT
L
Liza Lahaye
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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