title: [Radiotherapy phase I trials' methodology: Features].
abstract: In clinical research, biostatistical methods allow the rigorous analysis of data collection and should be defined from the trial design to obtain the appropriate experimental approach. Thus, if the main purpose of phase I is to determine the dose to use during phase II, methodology should be finely adjusted to experimental treatment(s). Today, the methodology for chemotherapy and targeted therapy is well known. For radiotherapy and chemoradiotherapy phase I trials, the primary endpoint must reflect both effectiveness and potential treatment toxicities. Methodology should probably be complex to limit failures in the following phases. However, there are very few data about methodology design in the literature. The present study focuses on these particular trials and their characteristics. It should help to raise existing methodological patterns shortcomings in order to propose new and better-suited designs.
authors.affiliation: Département d'oncologie médicale, institut de cancérologie de la Loire Lucien-Neuwirth, 108 bis, avenue Albert-Raimond, BP 60008, 42271 Saint-Priest-en-Jarez cedex, France.
authors.forename: R
authors.initials: R
authors.lastname: Rivoirard
authors.affiliation: Département de radiothérapie, institut de cancérologie de la Loire Lucien-Neuwirth, 108 bis, avenue Albert-Raimond, BP 60008, 42271 Saint-Priest-en-Jarez cedex, France.
authors.forename: A
authors.initials: A
authors.lastname: Vallard
authors.affiliation: Département de radiothérapie, institut de cancérologie de la Loire Lucien-Neuwirth, 108 bis, avenue Albert-Raimond, BP 60008, 42271 Saint-Priest-en-Jarez cedex, France.
authors.forename: J
authors.initials: J
authors.lastname: Langrand-Escure
authors.affiliation: Département de radiothérapie, institut de cancérologie de la Loire Lucien-Neuwirth, 108 bis, avenue Albert-Raimond, BP 60008, 42271 Saint-Priest-en-Jarez cedex, France.
authors.forename: J-B
authors.initials: JB
authors.lastname: Guy
authors.affiliation: Département de radiothérapie, institut de cancérologie de la Loire Lucien-Neuwirth, 108 bis, avenue Albert-Raimond, BP 60008, 42271 Saint-Priest-en-Jarez cedex, France.
authors.forename: M
authors.initials: M
authors.lastname: Ben Mrad
authors.affiliation: Département de radiothérapie, institut de cancérologie de la Loire Lucien-Neuwirth, 108 bis, avenue Albert-Raimond, BP 60008, 42271 Saint-Priest-en-Jarez cedex, France.
authors.forename: X
authors.initials: X
authors.lastname: Yaoxiong
authors.affiliation: Département de radiothérapie, institut de cancérologie de la Loire Lucien-Neuwirth, 108 bis, avenue Albert-Raimond, BP 60008, 42271 Saint-Priest-en-Jarez cedex, France.
authors.forename: P
authors.initials: P
authors.lastname: Diao
authors.affiliation: Département d'oncologie médicale, institut de cancérologie de la Loire Lucien-Neuwirth, 108 bis, avenue Albert-Raimond, BP 60008, 42271 Saint-Priest-en-Jarez cedex, France.
authors.forename: B
authors.initials: B
authors.lastname: Méry
authors.affiliation: Département de radiothérapie, institut de cancérologie de la Loire Lucien-Neuwirth, 108 bis, avenue Albert-Raimond, BP 60008, 42271 Saint-Priest-en-Jarez cedex, France.
authors.forename: G
authors.initials: G
authors.lastname: Pigne
authors.affiliation: Département de radiothérapie, institut de cancérologie de la Loire Lucien-Neuwirth, 108 bis, avenue Albert-Raimond, BP 60008, 42271 Saint-Priest-en-Jarez cedex, France.
authors.forename: C
authors.initials: C
authors.lastname: Rancoule
authors.affiliation: Département de radiothérapie, institut de cancérologie de la Loire Lucien-Neuwirth, 108 bis, avenue Albert-Raimond, BP 60008, 42271 Saint-Priest-en-Jarez cedex, France. Electronic address: nicolas.magne@icloire.fr.
authors.forename: N
authors.initials: N
authors.lastname: Magné
mesh_terms: D000465:Algorithms; D059248:Chemoradiotherapy; D017321:Clinical Trials, Phase I as Topic / Q000379:methods*; D006801:Humans; D009369:Neoplasms / Q000532:radiotherapy* / Q000628:therapy; D011832:Radiation Injuries / Q000517:prevention & control; D011878:Radiotherapy / Q000009:adverse effects / Q000379:methods*; D011879:Radiotherapy Dosage
keywords: Chemoradiotherapy; Chimioradiothérapie; Doses; Methodology; Méthodologie; Phase I; Radiotherapy; Radiothérapie; Toxicities; Toxicité