Evidence map›Paper›PMID 36653060›Full record

Trial reportInternational journal of gynecological cancer : official journal of the International Gynecological Cancer Society2023

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).

Lilian T Gien, Brian Slomovitz, Ate Van der Zee, Maaike Oonk

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of gynecological cancer : official journal of the International Gynecological Cancer Society, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05076942 (Groningen International Study on Sentinel Nodes in Vulvar Cancer-III, a Prospective Phase II Treatment Trial), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05076942 phase2recruitingnot on this map

Groningen International Study on Sentinel Nodes in Vulvar Cancer-III, a Prospective Phase II Treatment Trial

TypeinterventionalSponsorUniversity Medical Center GroningenRan2021 to 2029Enrolled157ConditionsVulvar Cancer, Sentinel Lymph Node, Lymph Node MetastasesArmsRadiotherapy combined with cisplatin, Cisplatin
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
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  3. Review
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  7. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 3 countries.

Lilian T GienDepartment of Gynecologic Oncology, Odette Cancer Centre, Toronto, Ontario, Canada Lilian.Gien@sunnybrook.ca.ORCID 0000-0002-6558-3337
Brian SlomovitzMount Sinai Medical Center, Miami Beach, Florida, USA.
Ate Van der ZeeDepartment of Gynecologic Oncology, University Medical Centre Groningen, Groningen, The Netherlands.
Maaike OonkDepartment of Gynecologic Oncology, University Medical Centre Groningen, Groningen, The Netherlands.
University Medical Center Groningen · NLMount Sinai Medical Center · USSunnybrook Health Science Centre · CA

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
NCI NIH HHS U10 CA180868
6 · The paper itself

Abstract

backgroundStandard 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

objectiveTo 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

designThis 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

resultsJanuary 1, 2029. TRIAL REGISTRATION NUMBER: NCT05076942.

Indexed as

Sentinel Lymph NodeVulvar NeoplasmsCisplatinExtranodal ExtensionFemaleHumansLymphatic MetastasisLymph Node ExcisionLymph NodesNeoplasm MicrometastasisProspective StudiesSentinel Lymph Node BiopsyCisplatinGynecologic Surgical ProceduresRadiation OncologySentinel Lymph NodeVulvar Neoplasms

Identifiers

PMID36653060
PMCPMC10233466
OpenAlexW4317234272

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.