{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T01:11:24Z","timestamp":1760145084202,"version":"build-2065373602"},"reference-count":67,"publisher":"MDPI AG","issue":"6","license":[{"start":{"date-parts":[[2024,6,17]],"date-time":"2024-06-17T00:00:00Z","timestamp":1718582400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Current Oncology"],"abstract":"<jats:p>In controlled phase II trials, major prognostic factors need to be well balanced between arms. The main procedures used are SPBR (Stratified Permuted Block Randomization) and minimization. First, we provide a systematic review of the treatment allocation procedure used in gastrointestinal oncology controlled phase II trials published in 2019. Second, we performed simulations using data from six phase II studies to measure the impacts of imbalances and bias on the efficacy estimations. From the 40 articles analyzed, all mentioned randomization in both the title and abstract, the median number of patients included was 109, and 77.5% were multicenter. Of the 27 studies that reported at least one stratification variable, 10 included the center as a stratification variable, 10 used minimization, 9 used SBR, and 8 were unspecified. In real data studies, the imbalance increased with the number of centers. The total and marginal imbalances were higher with SBR than with minimization, and the difference increased with the number of centers. The efficiency estimates per arm were close to the original trial estimate in both procedures. Minimization is often used in cases of numerous centers and guarantees better similarity between arms for stratification variables for total and marginal imbalances in phase II trials.<\/jats:p>","DOI":"10.3390\/curroncol31060259","type":"journal-article","created":{"date-parts":[[2024,6,18]],"date-time":"2024-06-18T03:42:06Z","timestamp":1718682126000},"page":"3513-3528","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["How to Balance Prognostic Factors in Controlled Phase II Trials: Stratified Permuted Block Randomization or Minimization? An Analysis of Clinical Trials in Digestive Oncology"],"prefix":"10.3390","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0821-8971","authenticated-orcid":false,"given":"Elodie","family":"Martin","sequence":"first","affiliation":[{"name":"Institut de Canc\u00e9rologie de l\u2019Ouest, F 49055 Angers, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3226-8525","authenticated-orcid":false,"given":"Karine","family":"Le Malicot","sequence":"additional","affiliation":[{"name":"F\u00e9d\u00e9ration Francophone de Canc\u00e9rologie Digestive (FFCD), EPICAD INSERM LNC-UMR 1231, University of Burgundy, F 21078 Dijon, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7493-4314","authenticated-orcid":false,"given":"Catherine","family":"Gu\u00e9rin-Charbonnel","sequence":"additional","affiliation":[{"name":"Institut de Canc\u00e9rologie de l\u2019Ouest, F 49055 Angers, France"},{"name":"CRCI2NA, INSERM U1307, CNRS UMR6075, University of Nantes, F 44000 Nantes, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fran\u00e7ois","family":"Bocquet","sequence":"additional","affiliation":[{"name":"Institut de Canc\u00e9rologie de l\u2019Ouest, F 49055 Angers, France"},{"name":"Law and Social Change Laboratory, Faculty of Law and Political Sciences, CNRS UMR 6297, Nantes University, F 44035 Nantes, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8284-3743","authenticated-orcid":false,"given":"Olivier","family":"Bouch\u00e9","sequence":"additional","affiliation":[{"name":"Department of Digestive Oncology, CHU Reims, F 51092 Reims, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2282-0101","authenticated-orcid":false,"given":"Anthony","family":"Turpin","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, University Hospital, F 59000 Lille, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8834-6927","authenticated-orcid":false,"given":"Thomas","family":"Aparicio","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Saint Louis Hospital, APHP, Universit\u00e9 Paris Cit\u00e9, F 75010 Paris, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean-Louis","family":"Legoux","sequence":"additional","affiliation":[{"name":"Department of Hepato-Gastroenterology and Digestive Oncology, Centre Hospitalier R\u00e9gional, F 45100 Orl\u00e9ans, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laetitia","family":"Dahan","sequence":"additional","affiliation":[{"name":"C.H.U. la Timone and Universit\u00e9 de la M\u00e9diterran\u00e9e Marseille, F 13005 Marseille, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julien","family":"Taieb","sequence":"additional","affiliation":[{"name":"Institut du Cancer Paris CARPEM, Gastroenterology and Digestive Oncology Department, APHP Centre\u2013Universit\u00e9 Paris Cit\u00e9, H\u00f4pital Europ\u00e9en G. Pompidou, F 75015 Paris, France"},{"name":"Centre de Recherche des Cordeliers, INSERM, CNRS, Sorbonne Universit\u00e9, USPC, Universit\u00e9 de Paris, Universit\u00e9 Paris Cit\u00e9, F 75006 Paris, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9211-4707","authenticated-orcid":false,"given":"C\u00f4me","family":"Lepage","sequence":"additional","affiliation":[{"name":"Department of HGE & Digestive Oncology, EPICAD INSERM UMR LNC 1231, University Hospital Dijon, University of Burgundy, F 21078 Dijon, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Louis-Marie","family":"Dourthe","sequence":"additional","affiliation":[{"name":"Service d\u2019Oncologie M\u00e9dicale, Clinique St Anne, F 67000 Strasbourg, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Caroline","family":"P\u00e9torin","sequence":"additional","affiliation":[{"name":"Service d\u2019Oncologie Digestive, CHU Clermont-Ferrand, F 63000 Clermont-Ferrand, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vincent","family":"Bourgeois","sequence":"additional","affiliation":[{"name":"Service d\u2019Oncologie Digestive, Centre Hospitalier de Boulogne sur Mer, F 62321 Boulogne-sur-Mer, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6305-8953","authenticated-orcid":false,"given":"Jean-Luc","family":"Raoul","sequence":"additional","affiliation":[{"name":"Institut de Canc\u00e9rologie de l\u2019Ouest, F 49055 Angers, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1404-0292","authenticated-orcid":false,"given":"Val\u00e9rie","family":"Seegers","sequence":"additional","affiliation":[{"name":"Institut de Canc\u00e9rologie de l\u2019Ouest, F 49055 Angers, France"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2024,6,17]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"7199","DOI":"10.1200\/JCO.2005.01.149","article-title":"Design Issues of Randomized Phase II Trials and a Proposal for Phase II Screening Trials","volume":"23","author":"Rubinstein","year":"2005","journal-title":"J. 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