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).
Gynecologic Surgical Procedures
Radiation Oncology
Sentinel Lymph Node
Vulvar Neoplasms
Journal
International journal of gynecological cancer : official journal of the International Gynecological Cancer Society
ISSN: 1525-1438
Titre abrégé: Int J Gynecol Cancer
Pays: England
ID NLM: 9111626
Informations de publication
Date de publication:
03 04 2023
03 04 2023
Historique:
medline:
5
4
2023
pubmed:
19
1
2023
entrez:
18
1
2023
Statut:
epublish
Résumé
Standard treatment of early-stage vulvar cancer is a radical, wide, local excision of the primary tumor and a sentinel lymph node (SLN) procedure for the groins. An inguinofemoral lymphadenectomy is no longer necessary for patients who have a negative SLN or micrometastasis ( To investigate the safety of replacing inguinofemoral lymphadenectomy by chemoradiation in patients with early-stage vulvar cancer with a macrometastasis (>2 mm) and/or extracapsular extension in the sentinel node. Combination of 56 Gy of radiation to the inguinal site and concurrent cisplatin chemotherapy without completion inguinofemoral lymphadenectomy will be feasible and safe, with low groin recurrence rates. This is a single-arm, prospective phase II treatment trial with stopping rules for unacceptable groin recurrences. Eligible patients will receive 56 Gy of radiation to the involved inguinal site and chemotherapy with concurrent cisplatin. Eligible patients undergoing sentinel node procedure will have stage I, unifocal, invasive (>1 mm depth of invasion) squamous cell carcinoma of the vulva with tumor size <4 cm, and no suspicious nodes on imaging. Those eligible for the trial are those with a metastasis >2 mm in the sentinel node and/or extracapsular extension, or more than one sentinel node with micrometastasis ≤2 mm. Groin recurrence rate in the first 2 years after primary treatment. 157 patients with macrometastases in their SLN. January 1, 2029. NCT05076942.
Sections du résumé
BACKGROUND
Standard treatment of early-stage vulvar cancer is a radical, wide, local excision of the primary tumor and a sentinel lymph node (SLN) procedure for the groins. An inguinofemoral lymphadenectomy is no longer necessary for patients who have a negative SLN or micrometastasis (
PRIMARY OBJECTIVE
To investigate the safety of replacing inguinofemoral lymphadenectomy by chemoradiation in patients with early-stage vulvar cancer with a macrometastasis (>2 mm) and/or extracapsular extension in the sentinel node.
STUDY HYPOTHESIS
Combination of 56 Gy of radiation to the inguinal site and concurrent cisplatin chemotherapy without completion inguinofemoral lymphadenectomy will be feasible and safe, with low groin recurrence rates.
TRIAL DESIGN
This is a single-arm, prospective phase II treatment trial with stopping rules for unacceptable groin recurrences. Eligible patients will receive 56 Gy of radiation to the involved inguinal site and chemotherapy with concurrent cisplatin.
MAJOR INCLUSION/EXCLUSION CRITERIA
Eligible patients undergoing sentinel node procedure will have stage I, unifocal, invasive (>1 mm depth of invasion) squamous cell carcinoma of the vulva with tumor size <4 cm, and no suspicious nodes on imaging. Those eligible for the trial are those with a metastasis >2 mm in the sentinel node and/or extracapsular extension, or more than one sentinel node with micrometastasis ≤2 mm.
PRIMARY ENDPOINT
Groin recurrence rate in the first 2 years after primary treatment.
SAMPLE SIZE
157 patients with macrometastases in their SLN.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS
January 1, 2029.
TRIAL REGISTRATION NUMBER
NCT05076942.
Identifiants
pubmed: 36653060
pii: ijgc-2022-004122
doi: 10.1136/ijgc-2022-004122
pmc: PMC10233466
mid: NIHMS1867176
doi:
Substances chimiques
Cisplatin
Q20Q21Q62J
Banques de données
ClinicalTrials.gov
['NCT05076942']
Types de publication
Clinical Trial, Phase II
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
619-622Subventions
Organisme : NCI NIH HHS
ID : U10 CA180868
Pays : United States
Informations de copyright
© IGCS and ESGO 2023. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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