A. Doussau

Design of placebo-controlled randomized trials of anticancer agents: Ethical considerations based on a review of published trials

A. Doussau, Isha Agarwal, Tito Fojo, Ian F. Tannock et autres

BACKGROUND: Limited information exists about the design of placebo-controlled cancer trials. Through a systematic review of trials published in 2013, we describe placebo use in randomized trials testing anticancer agents and analyze strategies that increase exposure to the experimental regimen. METHODS: Trials …

us, ca (code pays fourni par la source)

Comparison between protocols and publications for prognostic and predictive cancer biomarker studies

A. Doussau, Esther Vinarov, Brianna Barsanti-Innes, Jonathan Kimmelman

BACKGROUND: Method prespecification in study protocols is important for controlling bias in reports. The primary goal of this study was to assess potential for discordance between study protocols and publications reporting predictive or prognostic cancer biomarker research. Secondary objectives included comparing characteristics …

ca (code pays fourni par la source)

Benefit, burden, and impact for a cohort of post-approval cancer combination trials

Benjamin Gregory Carlisle, A. Doussau, Jonathan Kimmelman

BACKGROUND: After approval, drug developers often pursue trials aimed at extending the uses of a new drug by combining it with other drugs. Little is known about the risk and benefits associated with such research. METHODS: To establish a historic benchmark of …

ca (code pays fourni par la source)

Deciphering assumptions about stepped wedge designs: the case of Ebola vaccine research

A. Doussau, Christine Grady

Ethical concerns about randomising persons to a no-treatment arm in the context of Ebola epidemic led to consideration of alternative designs. The stepped wedge (SW) design, in which participants or clusters are randomised to receive an intervention at different time points, gained …

us (code pays fourni par la source)

One-Year Mortality in Older Patients with Cancer: Development and External Validation of an MNA-Based Prognostic Score

I. Bourdel‐Marchasson, Abou Diallo, Carine Bellera, C. Blanc-Bisson et autres

PURPOSE: The MNA (Mini Nutritional Assessment) is known as a prognosis factor in older population. We analyzed the prognostic value for one-year mortality of MNA items in older patients with cancer treated with chemotherapy as the basis of a simplified prognostic score. …

fr (code pays fourni par la source)

Innovations for phase I dose-finding designs in pediatric oncology clinical trials

A. Doussau, Birgit Geoerger, Irène Jiménez, Xavier Paolettí

us, fr (code pays fourni par la source)

French multicentre clinical evaluation of helical TomoTherapy® for anal cancer in a cohort of 64 consecutive patients

V. Vendrely, B. Henriques de Figueiredo, E. Rio, J. Benech et autres

PURPOSE/OBJECTIVES: To assess feasibility and toxicity of Helical TomoTherapy for treating anal cancer patients. METHODS: From 2007 to 2011, 64 patients were consecutively treated with TomoTherapy in three centres for locally advanced squamous-cell anal carcinoma (T2 > 4 cm or N positive). …

fr (code pays fourni par la source)

Dose finding with longitudinal data: simpler models, richer outcomes

Xavier Paolettí, A. Doussau, Monia Ezzalfani, Elisa Rizzo et autres

Phase I oncology clinical trials are designed to identify the optimal dose that will be recommended for phase II trials. This dose is typically defined as the dose associated with a certain probability of severe toxicity at cycle 1, although toxicity is …

fr, be (code pays fourni par la source)

Diagnostic and Prognostic Value of BCL2 Rearrangement in 53 Patients With Follicular Lymphoma Presenting as Primary Skin Lesions

Anne Pham‐Ledard, Anne Cowppli‐Bony, A. Doussau, Martina Prochazkova‐Carlotti et autres

OBJECTIVES: To study the diagnostic value of BCL2 rearrangement in follicle center lymphoma (FCL) presenting as primary skin lesions, evaluate its prevalence and the prognostic value in primary cutaneous FCL (PCFCL), and assess prognostic factors in PCFCL. METHODS: Fifty-three patients with a …

fr (code pays fourni par la source)

A new approach to integrate toxicity grade and repeated treatment cycles in the analysis and reporting of phase I dose-finding trials

A. Doussau, Rodolphe Thiébaut, Birgit Geoerger, P. Schöffski et autres

fr, in, be (code pays fourni par la source)

90Y-ibritumomab tiuxetan, fludarabine, busulfan and antithymocyte globulin reduced-intensity allogeneic transplant conditioning for patients with advanced and high-risk B-cell lymphomas

Krimo Bouabdallah, S. Fürst, Julien Asselineau, Patrice Chevalier et autres

fr, bz, us (code pays fourni par la source)

Nutritional Advice in Older Patients at Risk of Malnutrition during Treatment for Chemotherapy: A Two-Year Randomized Controlled Trial

Isabelle Bourdel‐Marchasson, C. Blanc-Bisson, A. Doussau, Christine Germain et autres

OBJECTIVE: We tested the effect of dietary advice dedicated to increase intake in older patients at risk for malnutrition during chemotherapy, versus usual care, on one-year mortality. METHOD: We conducted a multicentre, open-label interventional, stratified (centre), parallel randomised controlled trial, with a …

fr (code pays fourni par la source)