Actively Recruiting
Led by University Medical Center Groningen · Updated on 2023-08-01
157
Participants Needed
27
Research Sites
52 weeks
Total Duration
U
University Medical Center Groningen
Lead Sponsor
D
Dutch Cancer Society
Collaborating Sponsor
This research aims to evaluate a new treatment approach for early-stage vulvar cancer patients who have sentinel lymph node (SN) metastases larger than 2mm. Traditionally, these patients undergo an inguinofemoral lymphadenectomy (IFL), a surgery linked to significant side effects like wound problems and leg swelling. Previous studies showed that radiotherapy alone was not enough for larger metastases, so this trial tests adding chemotherapy to improve treatment. Participants receive chemoradiation, which includes inguinofemoral radiotherapy totaling 56 Gy over 5 to 6 weeks, combined with weekly intravenous cisplatin chemotherapy. The radiotherapy is delivered in daily doses with a focused boost to affected lymph nodes. This study is a phase II trial designed to monitor safety and effectiveness, with rules to stop if groin recurrences become too frequent. During the study, participants will be closely monitored for groin recurrences within the first two years after treatment. Assessments include checking for treatment-related side effects, quality of life surveys specific to vulvar cancer, and regular follow-up visits. Researchers aim to gather detailed information about the safety of replacing surgery with chemoradiation and the impact on patients' well-being over time.
CONDITIONS
Groningen International Study on Sentinel Nodes in Vulvar Cancer-III
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 to 6 weeks
Participants receive chemoradiation consisting of inguinofemoral radiotherapy combined with weekly cisplatin for early stage vulvar cancer with sentinel node metastasis.
Weekly visits for chemoradiation over 5 to 6 weeks
Duration - Up to 2 years
Participants are monitored for groin recurrence and treatment-related morbidity, with assessments of quality of life over the first two years after treatment.
Regular follow-up visits during the first 2 years after treatment
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
M
Maaike H Oonk, MD PhD
L
Liza Lahaye
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Lilian T Gien, Brian Slomovitz, Ate Van der Zee...
https://pubmed.ncbi.nlm.nih.gov/36653060