Search results for "randomization"
showing 10 items of 148 documents
Phase III study in stage IV non-small-cell lung cancer patients treated with two courses of cisplatin/gemcitabine followed by a randomization to thre…
2007
BACKGROUND: This randomised phase III study investigated if in responsive and stable disease (SD) stage IV patients after two courses of cisplatin and gemcitabine, single-agent gemcitabine (experimental arm) was not inferior in terms of overall survival (OS) to cisplatin-gemcitabine (standard arm). PATIENTS AND METHODS: Noninferiority was defined as an increase in the hazard of death (HR) < or = 1.33 in the experimental arm. From January 2001 to February 2004, 340 patients were registered and 250 were randomised. Cisplatin was administered on day 1 at 75 mg/m2 and Gemcitabine on days 1 and 8 at 1250 mg/m2 every 3 weeks. RESULTS: Response rate after two courses was 29%. The 1-year progressio…
The Impact of Radiotherapy Protocol Adherence on the Treatment Outcome in Patients With Locally Advanced NSCLC Treated With Concurrent Chemoradiation…
2021
PURPOSE/OBJECTIVE(S) The success of intensification and personalization of the curative treatment of non-small cell lung cancer (NSCLC) is strongly associated with the precision in radiotherapy (RT) treatment, which must therefore follow high standards. Herein we evaluate the impact of RT protocol adherence in the prospective international multicenter trial on curative treatment of NSCLC. MATERIALS/METHODS In the open-label, randomized, controlled PET-Plan trial, patients with inoperable NSCLC were randomized at a 1:1 ratio regarding the target volume delineation informed by ¹⁸F-FDG PET and CT plus elective nodal irradiation (Arm A) or target volumes informed by PET alone (Arm B) and receiv…
Validation of the AJCC prognostic stage for HER2-positive breast cancer in the ShortHER trial
2019
Abstract Background The 8th edition of the American Joint Committee on Cancer (AJCC) staging has introduced prognostic stage based on anatomic stage combined with biologic factors. We aimed to validate the prognostic stage in HER2-positive breast cancer patients enrolled in the ShortHER trial. Methods The ShortHER trial randomized 1253 HER2-positive patients to 9 weeks or 1 year of adjuvant trastuzumab combined with chemotherapy. Patients were classified according to the anatomic and the prognostic stage. Distant disease-free survival (DDFS) was calculated from randomization to distant relapse or death. Results A total of 1244 patients were included. Compared to anatomic stage, the prognost…
Dose-response relationship in the context of a maintenance randomized control trial: reanalysis of the PRODIGE 9 trial
2019
Introduction The dose-response relationship is considered as one of the major criteria when the causality of a relationship between an exposure and an outcome is discussed. This criterion is mainly studied in observational studies but may be also of interest in Randomized Controlled Trial (RCT), particularly if the administered dose of treatment varies over time and between patients. Maintenance trials with a long follow-up meet these characteristics. We reanalyzed a maintenance trial in digestive oncology (PRODIGE 9 trial) in order to explore the dose-response relationship between the maintenance treatment and overall survival (OS). Methods The PRODIGE 9 study was a maintenance trial asses…
Evaluation of atezolizumab immunogenicity: Efficacy and safety (Part 2).
2022
Abstract Antibody therapeutics can be associated with unwanted immune responses resulting in the development of anti‐drug antibodies (ADA). Optimal methods to evaluate the potential effects of ADA on clinical outcomes in oncology are not well established. In this study, we assessed efficacy and safety, based on ADA status, in patients from over 10 clinical trials that evaluated the immune checkpoint inhibitor atezolizumab as a single agent or as combination therapy for several types of advanced cancers. ADA can only be observed post randomization, and imbalances in baseline prognostic factors can confound the interpretation of ADA impact. We applied methodology to account for the confoundin…
Supportive Efficacy Analyses for the Phase 3 Study of Temsirolimus Versus Investigator’s Choice Therapy for the Treatment of Patients with Relapsed o…
2008
Abstract Temsirolimus (Torisel®) is a specific inhibitor of the mTOR kinase with antitumor activity in patients with relapsed or refractory mantle cell lymphoma. In a phase 3, randomized, open-label study, patients treated with temsirolimus 175 mg weekly 3 times followed by 75 mg weekly (175/75-mg) had significantly longer progression-free survival (PFS) than those treated with investigator’s choice therapy (p-value temsirolimus: investigator’s choice = 0.0009; hazard ratio = 0.44; 97.5% CI = 0.25, 0.78; Hess et al. J Clin Oncol.2008, 28:abs 8513). Patients treated with temsirolimus 175 mg weekly 3 times followed by 25 mg weekly (175/25-mg) showed a trend towards longer PFS than those treat…
Aceclofenac cream versus piroxicam cream in the treatment of patients with minor traumas and phlogistic affections of soft tissues: a double-blind st…
1995
Abstract The efficacy and safety of aceclofenac 1.5% cream and piroxicam 1% cream in 220 patients with soft-tissue injuries were evaluated in a double-blind, randomized, multicenter, comparative, parallel-group trial. Patients were randomly assigned to each treatment group to receive therapy three times a day for 7 days. The primary outcome measure of pain was evaluated using a visual analog scale (VAS) at baseline, day 4, and day 7 of the study. Safety was assessed by recording any adverse events that occurred and by monitoring any hemato-biochemical alterations during the study. After days 4 and 7 of treatment, a significant improvement ( P P
Thrombolysis plus heparin versus heparin alone in the acute phases of unstable angina: preliminary findings
1995
Abstract Several studies have shown conflicting effects of thrombolysis in patients with unstable angina. In these trials the time between presentation with chest pain and randomization was long (12 hours to 3 days). This study compared thrombolysis and heparin with heparin-alone treatment in patients in the acute phase of unstable angina. One hundred fifty-three consecutive patients hospitalized with chest pain at rest (first episode) lasting >5 minutes but P = 0.013). Data suggest that thrombolysis plus heparin produces faster clinical stabilization than heparin alone in patients treated during the acute phase of unstable angina.
Aceclofenac versus piroxicam in the management of osteoarthritis of the knee: A double-blind controlled study
1994
Abstract The objective of this study was to compare the efficacy and tolerability of aceclofenac tablets 100 mg twice daily with piroxicam tablets 20 mg once daily in the treatment of osteoarthritis of the knee or gonarthritis. A randomized, double-blind, controlled study of 3 months' duration was conducted in patients with gonarthritis diagnosed according to the World Health Organization criteria. A total of 212 patients were recruited; 205 patients fully complied with the inclusion-exclusion criteria. Of these, 103 received aceclofenac and 102 received piroxicam. Fourteen patients in the aceclofenac group and 12 patients in the piroxicam group who failed to complete the 3-month treatment …
Methodological Problems in RCTs on IBD
2012
Abstract: Randomized controlled trials (RCTs) are the gold standard method for developing evidence-based medicine in inflammatory bowel disease (IBD). Methodological problems in RCTs in IBD concern different aspects such as the definition of the study population due to the extreme variability of patients with IBD, the indices of disease activity, a clearly defined outcome, the environmental risk factors (i.e smoking behaviour) that may influence the randomization, the heterogeneous placebo rate of remission and the different statistical methods used to analyze the results. It is important that trials are designed efficiently, done well and complement clinical practice with a careful subject…