Le cancer demeure en France un problème majeur de santé publique : Cette pathologie reste la principale cause de mortalité, avec près de 150 000 décès chaque année. Afin de lutter contre cette maladie, le plan cancer 2014-2019 a posé comme objectif de développer la recherche clinique, en incluant dès 2019 au moins 50 000 patients par an dans des essais thérapeutiques. La recherche clinique en oncologie est en plein essor depuis l’avènement de thérapies telles que les thérapies moléculaires ciblées ou l’immunothérapie. Le nombre de nouveaux médicaments en développement en oncologie a augmenté de façon exponentielle depuis les années 2000. Il en découle un accroissement important du nombre de publications d’études en oncologie. L’analyse d’une étude n’est possible que si son schéma expérimental, sa réalisation et ses conditions d’analyse sont clairement décrits dans l’article publié. Le reporting est le fait de décrire dans une publication toutes les actions, notamment d’ordre méthodologiques, réalisées au cours de l’étude. 5 revues systématiques de la littérature ont été réalisées afin d’analyser le reporting des articles d’études en oncologie. La première étude a objectivé que la littérature était pauvre en articles analysant le reporting des études observationnelles (2% des publications) et que le reporting intrinsèque des revues systématiques récentes portant sur le sujet était exhaustif (score OQSR moyen (2010-2014) = 10, écart-type =2). 826 articles d’études ont été analysés dans la deuxième revue systématique, dont 84.5% d’études observationnelles. Les reporting des variables et du critère de jugement principal étaient clairs, respectivement dans 100% et 85.2% des cas. Une discordance de reporting pour le test statistique principal utilisé, entre les parties Méthodes et Résultats, a été identifié dans 23 articles. La troisième revue systématique a mis un évidence un manque de données sur le reporting des essais de phase II en oncologie (13 articles) et 3 scores d’évaluation du reporting avaient été décrits : score OQS, score KMS et score d’index de qualité. 557 publications d’essais de phase II ont été étudiées dans la quatrième revue systématique. Le score de reporting KMS était égal à 0, 1, 2, 3 respectivement pour 3,9%, 21,4%, 48,5% et 26,2% articles. En analyse multivariée, les 3 variables associées à la valeur du score KMS étaient : Le reporting clair du design statistique (OR = 2.22; IC 95% [1.36-3.65] ; p <0.001), l’essai monocentrique (OR = 0.25 [0.09 – 0.74] ; p = 0.012) et l’analyse menée per protocole (OR = 0.48; IC 95% [0.32 -0.72] ; p <0.001). La dernière revue systématique a porté sur 557 articles d’essais de phase II. 182 des essais de phase II (32.7%) ont abouti à la réalisation d’un essai de phase III, dont 57 avaient un critère de jugement principal positif et statistiquement significatif. En conclusion, le reporting des études en oncologie reste perfectible. Les points d’optimisation relevés sont l’élaboration de recommandations de reporting spécifique aux essais de phase II en oncologie et l’adhésion de l’ensemble des journaux médicaux aux différentes recommandations de reporting / Cancer remains a major public health problem in France : This pathology is the leading cause of death, with nearly 150,000 deaths each year. In order to fight against this disease, the 2014-2019 French cancer plan set the goal of developing clinical research, including at least 50,000 patients per year in 2019 in therapeutic trials. Clinical research in oncology has been booming since the advent of therapies such as targeted molecular therapies or immunotherapy. The number of new drugs being developed in oncology has increased exponentially since the 2000s, resulting in a significant increase in the number of oncology study publications. The analysis of a study is possible only if its experimental design, its realization and its conditions of analysis are clearly described in the published article. Reporting is the process of describing in a publication all the actions, including methodological ones, carried out during the study. 5 systematic reviews were conducted to analyze the reporting of oncology study articles. The first study showed that the literature was poor in articles analyzing the reporting of observational studies (2% of publications) and that the intrinsic reporting of recent systematic reviews on the subject was exhaustive (average OQSR score (2010-2014) = 10, standard deviation = 2). 826 articles of study were analyzed in the second systematic review, 84.5% of which were observational studies. The reporting of the variables and the primary endpoint were clear in 100% and 85.2% of the cases, respectively. A reporting discrepancy for the main statistical test used, between the Methods and Results parts, was identified in 23 articles. The third systematic review revealed a lack of data on the reporting of phase II trials in oncology (13 articles) and 3 reporting evaluation scores were described: OQS, KMS and quality index score. 557 phase II trial publications were reviewed in the fourth systematic review. The KMS reporting score was 0, 1, 2, 3 respectively for 3.9%, 21.4%, 48.5% and 26.2% publications. In multivariate analysis, the 3 variables associated with the KMS score were : Reporting of a clear statistical design (OR = 2.22, 95% CI [1.36-3.65], p <0.001), the single-center trial (OR = 0.25 [0.09 - 0.74], p = 0.012) and per protocol analysis (OR = 0.48, 95% CI [0.32-0.72], p <0.001). The last systematic review focused on 557 Phase II trial articles. 182 Phase II trials (32.7%) resulted in a Phase III trial, of which 57 had a positive and statistically significant primary endpoint. In conclusion, reporting of studies in oncology remains perfectible. Optimization points identified are the development of specific reporting recommendations for phase II trials in oncology and the adherence of all medical journals to the various reporting recommendations

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Background Primary radiochemotherapy with photons is the standard treatment for locally advanced-stage non-small cell lung cancer (NSCLC) patients. Acute radiation-induced side effects such as oesophagitis and radiation pneumonitis limit patients’ quality of life, and the latter can be potentially life-threatening. Due to its distinct physical characteristics, proton therapy enables better sparing of normal tissues, which is supposed to translate into a reduction of radiation-induced side effects. Methods/design This is a single-centre, prospective, randomised controlled, phase II clinical trial to compare photon to proton radiotherapy up to 66 Gy (RBE) with concomitant standard chemotherapy in patients with locally advanced-stage NSCLC. Patients will be allocated in a 1:1 ratio to photon or proton therapy, and treatment will be delivered slightly accelerated with six fractions of 2 Gy (RBE) per week. Discussion The overall aim of the study is to show a decrease of early and intermediate radiation-induced toxicity using proton therapy. For the primary endpoint of the study we postulate a decrease of radiation-induced side effects (oesophagitis and pneumonitis grade II or higher) from 39 to 12%. Secondary endpoints are locoregional and distant failure, overall survival and late side effects. Trial registration Registered at ClinicalTrials.gov with Identifier NCT02731001 on 1 April 2016.

Background Primary radiochemotherapy with photons is the standard treatment for locally advanced-stage non-small cell lung cancer (NSCLC) patients. Acute radiation-induced side effects such as oesophagitis and radiation pneumonitis limit patients’ quality of life, and the latter can be potentially life-threatening. Due to its distinct physical characteristics, proton therapy enables better sparing of normal tissues, which is supposed to translate into a reduction of radiation-induced side effects. Methods/design This is a single-centre, prospective, randomised controlled, phase II clinical trial to compare photon to proton radiotherapy up to 66 Gy (RBE) with concomitant standard chemotherapy in patients with locally advanced-stage NSCLC. Patients will be allocated in a 1:1 ratio to photon or proton therapy, and treatment will be delivered slightly accelerated with six fractions of 2 Gy (RBE) per week. Discussion The overall aim of the study is to show a decrease of early and intermediate radiation-induced toxicity using proton therapy. For the primary endpoint of the study we postulate a decrease of radiation-induced side effects (oesophagitis and pneumonitis grade II or higher) from 39 to 12%. Secondary endpoints are locoregional and distant failure, overall survival and late side effects. Trial registration Registered at ClinicalTrials.gov with Identifier NCT02731001 on 1 April 2016.