Evidence map›Paper›PMID 38627035›Full record

ArticleInternational journal of gynecological cancer : official journal of the International Gynecological Cancer Society2024

ENGOT-EN20/GOG-3083/XPORT-EC-042 - A phase III, randomized, placebo-controlled, double-blind, multicenter trial of selinexor in maintenance therapy after systemic therapy for patients with p53 wild-type, advanced, or recurrent endometrial carcinoma: rationale, methods, and trial design.

Ignace Vergote, Alejandro Perez Fidalgo, Giorgio Valabrega, Bradley J Monk, Thomas Herzog, David Cibula, Nicoletta Colombo, Bhavana Pothuri, Jalid Sehouli, Jacob Korach and 11 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in International journal of gynecological cancer : official journal of the International Gynecological Cancer Society, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05611931 (A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
4.7field-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.

NCT05611931 phase3active not recruitingnot on this map

A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

TypeinterventionalSponsorKaryopharm Therapeutics IncRan2023 to 2028Enrolled257ConditionsEndometrial CancerArmsSelinexor, Matching Placebo for selinexor
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 8 citations in OpenAlex.

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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

21 authors at 19 institutions in 11 countries.

Ignace VergoteUniversity Hospitals Leuven, Leuven, Belgium ignace.vergote@uz.kuleuven.ac.be.ORCID 0000-0002-7589-8981
Alejandro Perez FidalgoMedical Oncology, Hospital Clinico Universitario, Valencia, Spain.ORCID 0000-0003-3568-4345
Giorgio ValabregaDepartment of Oncology, University of Turin, Turin, Italy.ORCID 0000-0001-5444-6305
Bradley J MonkFlorida Cancer Specialists and Research Institute, West Palm Beach, Florida, USA.ORCID 0000-0001-6985-0159
Thomas HerzogDepartment of Obstetrics and Gynecology, University of Cincinnati, Cincinnati, Ohio, USA.
David CibulaCharles University and General University Hospital in Prague, Prague, Czech Republic.
Nicoletta ColomboGynecologic Oncology Program, European Institute of Oncology IRCCS, Milan, Italy.
Bhavana PothuriNYU Langone Health Perlmutter Cancer Center, New York, New York, USA.ORCID 0000-0003-4578-2061
Jalid SehouliDepartment of Gynecology, European Competence Center for Ovarian Cancer, Charité Comprehensive Cancer Center, Charité-Berlin University of Medicine, Berlin, Germany.ORCID 0000-0002-5963-6623
Jacob KorachSheba Medical Center, Tel Hashomer, Israel.ORCID 0000-0003-0483-4582
Joyce BarlinWomen's Cancer Care Associates, LLC, Albany, New York, USA.
Christos A PapadimitriouDepartment of Clinical Therapeutics, University of Athens School of Medicine, Athens, Greece.
Toon van GorpUniversity Hospitals Leuven, Leuven, Belgium.ORCID 0000-0002-2564-721X
Debra RichardsonStephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.ORCID 0000-0002-3992-8610
Michael McCarthyGalway University Hospitals, Galway, Ireland.
Yoland AntillFrankston Hospital, Frankston and Monash University, Frankston, Victoria, Australia.
Mansoor Raza MirzaDepartment of Oncology, Rigshospitalet; Copenhagen University Hospital, Copenhagen, Denmark.ORCID 0000-0002-8085-1010
Kai LiKaryopharm Therapeutics Inc, Newton, Massachusetts, USA.
Pratheek KalyanapuKaryopharm Therapeutics Inc, Newton, Massachusetts, USA.
Brian SlomovitzFlorida Cancer Specialists and Research Institute, West Palm Beach, Florida, USA.ORCID 0000-0002-7241-3096
Robert L ColemanGynecologic Oncology Group (GOG) Foundation, Prague, Czech Republic.ORCID 0000-0001-9343-8754
Gynecologic Oncology Group · USKaryopharm Therapeutics (United States) · USCancerCare · USCharité - Universitätsmedizin Berlin · DECharles University · CZCopenhagen University Hospital · DKEuropean Institute of Oncology · ITFrankston Hospital · AUHospital Clínico Universitario de Valencia · ESItalian Association for Cancer Research · ITKU Leuven · BEMount Sinai Medical Center · USNational and Kapodistrian University of Athens · GRNYU Langone Health · USTel Aviv University · ILUniversity Hospital Galway · IEUniversity of Cincinnati · USUniversity of Oklahoma Health Sciences Center · USVlaams Instituut voor Biotechnologie · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with advanced/recurrent endometrial cancer have a poor prognosis and limited treatment options. Biomarkers such as tumor protein 53 ( PRIMARY

objectiveTo evaluate the efficacy of selinexor compared with placebo as maintenance therapy in patients with advanced or recurrent STUDY HYPOTHESIS: Selinexor administered at 60 mg weekly as maintenance therapy will show manageable safety and maintain efficacy in patients with TRIAL

designThis is a prospective, multicenter, double-blind, placebo-controlled, randomized phase III study designed to evaluate the efficacy and safety of selinexor as a maintenance therapy in patients with advanced or recurrent MAJOR INCLUSION/EXCLUSION CRITERIA: Eligible patients must have histologically confirmed endometrial cancer, PRIMARY ENDPOINT: The primary endpoint is investigator-assessed progression-free survival per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in the intent-to-treat population. SAMPLE SIZE: A total of 220 patients will be enrolled. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING

resultsAccrual is expected to be completed in 2024 with presentation of results in 2025.

trial registrationNCT05611931.

Indexed as

Endometrial NeoplasmsHydrazinesNeoplasm Recurrence, LocalTriazolesClinical Trials, Phase III as TopicDouble-Blind MethodFemaleHumansMaintenance ChemotherapyMulticenter Studies as TopicRandomized Controlled Trials as TopicTumor Suppressor Protein p53HydrazinesselinexorTP53 protein, humanTriazolesTumor Suppressor Protein p53Uterine Cancer

Identifiers

PMID38627035
PMCPMC11347228
OpenAlexW4394855975

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.