{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Bhatia AK"],"funding":["NCATS NIH HHS","NCI","NCI NIH HHS"],"pagination":["4653-4662"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC5693641"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["123(23)"],"pubmed_abstract":["<h4>Background</h4>13-Cis retinoic acid (13-CRA) is a synthetic vitamin A derivative. High-dose 13-CRA in patients with squamous cell cancers of the head and neck (SCCHNs) reduces the incidence of second primary tumors (SPTs). The authors report long-term results from a phase 3 randomized trial that compared treatment with low-dose 13-CRA versus placebo for patients who had early stage SCCHN, with a focus on the development of SPTs and overall survival (OS).<h4>Methods</h4>In total, 176 patients who received treatment for stage I/II SCCHN were randomized to receive either low-dose 13-CRA (weight-based dose of 7.5 mg or 10 mg) or placebo for 2 years. A competing-risk approach and the log-rank test were used to compare the time to SPT and OS, respectively, between groups.<h4>Results</h4>13-C"],"journal":["Cancer"],"pubmed_title":["Double-blind, randomized phase 3 trial of low-dose 13-cis retinoic acid in the prevention of second primaries in head and neck cancer: Long-term follow-up of a trial of the Eastern Cooperative Oncology Group-ACRIN Cancer Research Group (C0590)."],"pmcid":["PMC5693641"],"funding_grant_id":["U10 CA035199","U10 CA016116","UL1 TR001863","U10 CA017145","U10 CA180790","U10 CA011083","U10 CA025224","U10 CA021661","U10 CA037417","U10 CA180816","UG1 CA232760","U10 CA037404","U10 CA035103","U10 CA013650","U10 CA037403","U10 CA052667","U10 CA180882","UG1 CA189862","U10 CA180801","U10 CA180868","U10 CA180802","U10 CA067753","U10 CA180821","U10 CA180822","UG1 CA189828","UG1 CA189805","U10 CA180826","UG1 CA189825"],"pubmed_authors":["Reiner SA","Rubin P","Jacobs CD","Burtness BA","Pandya KJ","Lee JW","Celano P","Li Y","Dunphy EP","Baez-Diaz L","Li S","Khandekar JD","Arusell RM","Adams GL","Bhatia AK","Limburg PJ","Pinto HA"],"additional_accession":[]},"is_claimable":false,"name":"Double-blind, randomized phase 3 trial of low-dose 13-cis retinoic acid in the prevention of second primaries in head and neck cancer: Long-term follow-up of a trial of the Eastern Cooperative Oncology Group-ACRIN Cancer Research Group (C0590).","description":"<h4>Background</h4>13-Cis retinoic acid (13-CRA) is a synthetic vitamin A derivative. High-dose 13-CRA in patients with squamous cell cancers of the head and neck (SCCHNs) reduces the incidence of second primary tumors (SPTs). The authors report long-term results from a phase 3 randomized trial that compared treatment with low-dose 13-CRA versus placebo for patients who had early stage SCCHN, with a focus on the development of SPTs and overall survival (OS).<h4>Methods</h4>In total, 176 patients who received treatment for stage I/II SCCHN were randomized to receive either low-dose 13-CRA (weight-based dose of 7.5 mg or 10 mg) or placebo for 2 years. A competing-risk approach and the log-rank test were used to compare the time to SPT and OS, respectively, between groups.<h4>Results</h4>13-C","dates":{"release":"2017-01-01T00:00:00Z","publication":"2017 Dec","modification":"2025-04-25T18:19:22.503Z","creation":"2019-03-27T00:09:11Z"},"accession":"S-EPMC5693641","cross_references":{"pubmed":["28786105"],"doi":["10.1002/cncr.30920"]}}