NRG-GY024
Open to Accrual
Protocol Information
Tab containing protocol details, study design, and eligibility criteria
Tab containing study documents, informed consent forms, and study materials
Tab containing information for potential study participants
Groningen International Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) III: A Prospective Phase II Treatment Trial
Principal Investigator
Brian M. Slomovitz
Status
Open to Accrual
Date Opened To Accrual
August 31, 2021
Disease Site
Gynecologic [GY] Cervix
Phase
II
Developmental Therapeutics
No
Primary Objective
The primary objective of this study is to investigate the safety of replacing inguinofemoral lymphadenectomy by chemoradiation in early-stage vulvar cancer patients with a macrometastasis (>2mm) and/or extracapsular extension in the Sentinel Lymph Node (SLN). The secondary objective is to evaluate the short and long-term morbidity associated with the SLN procedure and chemoradiation.
Patient Population
Early stage vulvar cancer with macrometastasis and/or extracapsular extension in the SLN
Target Accrual
15
Forms
Investigator Resources
Regulatory Resources
- Canadian-Document-List-of-Laboratories.docx
- Canadian-Document-No-Objection-Letter.pdf
- Memorandum-Canadian-Site-Activation-1.pdf
- Canadian-Document-Research-Ethics-Board-Attestation-Form_Amendment-4.docx
- Canadian-Document-No-Objection-Letter_Amendment-4.pdf
- Canadian-Document-NRG-GY024-Informed-Consent-Template_Amendment-4.docx
- Canadian-Document-Qualified-Investigator-Undertaking-Form_Amendment-4.docx
- Canadian-Document-Clinical-Trial-Site-Information-Form_Amendment-4.pdf
- Canadian-Document-Protocol-Signature-Form_Amendment-4.docx
- Canadian-Document-Site-Initiation-Visit-Completion-Form_Amendment-4.docx
- Canadian-Document-NRG-GY024-Training-Slides_Amendment-4.pptx
Study Memos
- NRG-GY024-Informational-Memo-Slomovitz-contact-info.pdf
- NRG-GY024-Activation-Memo.pdf
- NRG-GY024-Investigator-Skill-Verification.docx
- NRG-GY024-Amendments-1-and-2-Memo-02142022.pdf
- NRG-GY024-Amendment-3-Memo-01232023.pdf
- Memorandum-Canadian-Site-Activation.pdf
- NRG-Oncology-Drug-Shortage-Memo_16-Jun-2023.pdf
- NRG-GY024-Amendment-4-Memo-11272023.pdf
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.