Search results for "trials"
showing 10 items of 966 documents
Minimally invasive secondary cytoreduction plus HIPEC for recurrent ovarian cancer: a case series.
2014
Objective To analyze the feasibility of laparoscopic/robotic secondary cytoreductive surgery and hyperthermic intraperitoneal intra-operative chemotherapy (SCS + HIPEC) in a retrospective series of isolated platinum sensitive recurrent ovarian cancer. Methods We retrospectively evaluated a consecutive series of ovarian cancer patients with isolated platinum sensitive relapse. Isolated relapse was defined as the presence of a single nodule, in a single anatomic site. In all cases the presence of isolated relapse was assessed at pre-operative FDG-PET/CT scan, and confirmed with staging laparoscopy performed immediately before SCS + HIPEC. Results 84 women with platinum sensitive relapse recei…
Effects of Interrater Reliability of Psychopathologic Assessment on Power and Sample Size Calculations in Clinical Trials
2002
Although rater training is increasingly used to improve the quality of the investigated outcome parameters, the reliability of assessments is not perfect. Thus, empirical reliability estimates should be used instead of theoretically assumed perfect reliability. Implications of the reliability of psychiatric assessments for sample size and power calculations in clinical trials are presented. The theoretical basis of sample size and power calculations using empirical reliability scores is delineated. Examples from contemporary research on schizophrenia and depression are used to illustrate several implications for study design and interpretation of results. The tremendous impact of the lack o…
Perceived barriers in the outdoor environment and development of walking difficulties in older people
2012
SIR—Older people with mobility limitations often report more barriers in their outdoor environment than people with intact mobility [1]. However, it is uncertain whether older people perceive their environment as problematic because of their mobility limitations or whether the environmental barriers precede incident mobility limitation, as most studies have been limited to cross-sectional analyses [2–5]. Only a few longitudinal studies have shown that barriers in the outdoor environment, such as poor street conditions, poor lighting and heavy traffic, increase the risk for overall functional loss [6, 7] and decrease physical activity participation [8]. More knowledge is needed about the cha…
Lamotrigine compared to placebo and other agents with antidepressant activity in patients with unipolar and bipolar depression: a comprehensive meta-…
2016
ObjectivesTo meta-analytically summarize lamotrigine’s effectiveness and safety in unipolar and bipolar depression.MethodsWe conducted systematic PubMed and SCOPUS reviews (last search =10/01/2015) of randomized controlled trials comparing lamotrigine to placebo or other agents with antidepressant activity in unipolar or bipolar depression. We performed a random-effects meta-analysis of depression ratings, response, remission, and adverse effects calculating standardized mean difference (SMD) and risk ratio (RR) ±95% confidence intervals (CIs).ResultsEighteen studies (n=2152, duration=9.83 weeks) in patients with unipolar depression (studies=4, n=187; monotherapy vs lithium=1, augmentation …
Conventional induction and post-remission therapy in APL: have we arrived?
2014
Since the introduction of all-trans-retinoic acid, the use of this molecularly targeted treatment in combination with anthracycline-based chemotherapy has completely changed the prognosis of acute promyelocytic leukemia (APL) turning it into the most curable acute myeloid leukemia. Also, the use of risk-adapted protocols has optimized the drug combination and the most appropriate dose intensity for each subset of patients classified according to both risk of relapse and vulnerability to drug toxicity. Recent developments have included the investigation of the role of arsenic trioxide (ATO) as front-line treatment after its success in relapsed APL, both to minimize or even omit the use of cy…
Deep MRD profiling defines outcome and unveils different modes of treatment resistance in standard- and high-risk myeloma
2021
PETHEMA/GEM Cooperative Group.
Rationale and design of the CRAFT (Continuous ReAssessment with Flexible ExTension in Rare Malignancies) multicenter phase II trial.
2021
Background Approvals of cancer therapeutics are primarily disease entity specific. Current molecular diagnostic approaches frequently identify actionable alterations in rare cancers or rare subtypes of common cancers for which the corresponding treatments are not approved and unavailable within clinical trials due to entity-related eligibility criteria. Access may be negotiated with health insurances. However, approval rates vary, and critical information required for a scientific evaluation of treatment-associated risks and benefits is not systematically collected. Thus clinical trials with optimized patient selection and comprehensive molecular characterization are essential for translati…
Plerixafor is effective and safe for stem cell mobilization in heavily pretreated germ cell tumor patients.
2010
Up to 10% of germ cell tumor patients require salvage high-dose chemotherapy with stem cell support, achieving cure rates in the range of 10-60%. Stem cell mobilization may be difficult in these patients because of multiple lines of treatment known to seriously hamper stem cell recovery. Plerixafor significantly enhances the success of the CD34+ cell harvest, even in cases where prior mobilization attempts have failed. Six germ cell tumor patients provided informed consent and were included in the compassionate use program. All patients were heavily pretreated, with a median of 3.5 prior lines of therapy. All failed prior mobilization with G-CSF in combination with chemotherapy. Five patien…
Clinical assessment of patients with advanced non-small-cell lung cancer eligible for second-line chemotherapy
2010
Purpose: Knowledge of prognostic factors for advanced non-small-cell lung cancer (NSCLC) patients eligible for second-line treatment is scarce. The aim of this study was to assess the prognostic role of a number of routinely collected clinical variables and to provide a summary index to discriminate patients according to probability of survival.Methods: individual data from nine randomised trials of second-line treatment in advanced NSCLC were analysed. Primary end-point was overall survival (OS). Cox model, stratified by trial, was used for multivariate analyses, and a prognostic index was provided and validated according to an internal/external procedure.Results: Out of 1239 patients, 119…
Surrogate end points for overall survival and local control in neoadjuvant rectal cancer trials: statistical evaluation based on the FFCD 9203 trial.
2009
Abstract Background In resectable rectal cancer trials, pathological parameters are early preoperative treatment efficacy measures. Their validation as surrogate end points for long-term clinical outcomes would allow to reduce trial duration. The aim was to evaluate potential surrogates for overall survival (OS) and local control (LC) in preoperative T3/T4 rectal cancer trials. Candidate variables included ypT and ypN stages, T downstaging, tumor regression grade (TRG), and circumferential resection margin (CRM) status. Patients and methods In the Federation Francophone de Cancerologie Digestive (FFCD) 9203 trial, 742 eligible patients were randomly assigned to receive preoperative radiothe…