Groningen International Study on Sentinel Nodes in Vulvar Cancer-III
GROINSS-VIII
2 other identifiers
interventional
157
2 countries
27
Brief Summary
Vulvar cancer patients with SN-metastasis \> 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2021
Longer than P75 for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 15, 2021
CompletedFirst Posted
Study publicly available on registry
October 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
August 1, 2023
July 1, 2023
7 years
August 15, 2021
July 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Groin recurrence rate
Groin recurrence in the groin with SN metastasis treated with chemoradiation
Within first 2 years after primary treatment
Secondary Outcomes (3)
Treatment related morbidity
First two years after primary treatment
Quality of life as assessed using EORTC-QLQc30
First two year after primary treatment
Quality of life-vulvar cancer specific, as assessed using VU34
First two year after primary treatment
Study Arms (1)
Chemoradiation
EXPERIMENTALInguinofemoral radiotherapy (48-50 Gy in 1.8 Gy daily fractions, with a boost dose to the involved inguinal site for a total equivalent dose of 56 Gy over 5-6 weeks, preferably with simultaneous integrated boost technique) combined with weekly cisplatin 40 mg/m2 intravenously on days 1, 8, 15, 22 and 29
Interventions
Inguinofemoral radiotherapy combined with weekly cisplatin
Eligibility Criteria
You may qualify if:
- 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
- +4 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Medical Center Groningenlead
- Dutch Cancer Societycollaborator
- NRG Oncologycollaborator
Study Sites (27)
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
Catharina Hospital Eindhoven
Eindhoven, 5623EJ, Netherlands
University Medical Center Groningen
Groningen, 9712RB, Netherlands
Leiden University Medical Center
Leiden, 2333ZA, Netherlands
Radboud University Medical Center
Nijmegen, 6525GA, Netherlands
Erasmus Medical Center
Rotterdam, 3015GD, Netherlands
University Medical Center Utrecht
Utrecht, 3584CX, Netherlands
Related Publications (1)
Gien LT, Slomovitz B, Van der Zee A, Oonk M. Phase II activity trial of high-dose radiation and chemosensitization in patients with macrometastatic lymph node spread after sentinel node biopsy in vulvar cancer: GROningen INternational Study on Sentinel nodes in Vulvar cancer III (GROINSS-V III/NRG-GY024). Int J Gynecol Cancer. 2023 Apr 3;33(4):619-622. doi: 10.1136/ijgc-2022-004122.
PMID: 36653060DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
August 15, 2021
First Posted
October 13, 2021
Study Start
January 1, 2021
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2029
Last Updated
August 1, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share