Search results for "PHASE"
showing 10 items of 6344 documents
Cetuximab with irinotecan, folinic acid and 5-fluorouracil as first-line treatment in advanced gastroesophageal cancer: a prospective multi-center bi…
2011
Abstract Background Cetuximab plus irinotecan/folinic acid/5-fluorouracil (5-FU) (IF) was evaluated as first-line treatment of patients with advanced gastric cancer and gastroesophageal junction tumors. Preplanned analyses of the influence of tumor biomarkers on treatment outcome were carried out. Patients and methods Patients received weekly cetuximab (400 mg/m2 on day 1, subsequently 250 mg/m2) plus irinotecan (80 mg/m2) and a 24-hour continuous infusion of folinic acid (200 mg/m2) and 5-FU (1500 mg/m2) on days 1, 8, 15, 22, 29 and 36 of a 50-day cycle, until progressive disease (PD). Results The most common grade 3/4 toxic effects in 49 patients were diarrhea (15%) and skin toxic effects…
Arterially enhancing liver lesions: significance of sustained enhancement on hepatic venous and delayed phase with magnetic resonance imaging.
2007
Benign hepatic vascular neoplasms and vascular pseudolesions are commonly encountered in magnetic resonance (MR) imaging. Most of these benign lesions demonstrate not only arterial-phase hyperintensity, but also persistent enhancement on venous and delayed imaging, unlike most malignant hepatic masses. These features, along with other MR findings and morphological characteristics, may allow for more confident diagnosis and distinction from hepatic malignancy. The objective of our study was to illustrate the MR imaging findings of hepatic lesions that demonstrate both early arterial and sustained enhancement on hepatic venous and delayed phase.
Efficacy and Safety of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis:A Randomized, Placebo-Controlled, Phase II Study
2017
Objective To determine the effect of selexipag, an oral, selective IP prostacyclin receptor agonist, on the frequency of attacks of Raynaud's phenomenon (RP) in patients with systemic sclerosis (SSc). Methods Patients with SSc-related RP were randomized 1:1 to placebo (n = 38) or selexipag (n = 36) in individualized doses (maximum of 1,600 μg twice daily) during a 3-week titration period. The primary end point was the weekly average number of RP attacks during the study maintenance period, analyzed using a Bayesian approach with a negative binomial model adjusted for baseline number of RP attacks. Other outcome measures included Raynaud's Condition Score (RCS), RP attack duration, and treat…
CT enterography as a powerful tool for the evaluation of inflammatory activity in Crohn’s disease: relationship of CT findings with CDAI and acute-ph…
2014
Few studies have correlated computed tomography enterography (CTE) findings with Crohn’s disease (CD) clinical and biochemical activity. The aim of this study was to evaluate correlations between CTE findings with CD activity. The CTE datasets from 62 patients were retrospectively reviewed for different parameters: bowel wall thickening and hyperenhancement, mesenteric alterations, abdominal free fluid and complications related to the disease (fistulas, strictures, abscesses). Activity was assessed using the Crohn’s Disease Activity Index (CDAI) and some biochemical markers (C-reactive protein, erythrocyte sedimentation rate, alpha 2-globulins, fibrinogen, platelets, haemoglobin). Correlati…
A randomized phase II trial of irinotecan plus carboplatin versus etoposide plus carboplatin treatment in patients with extended disease small-cell l…
2006
Superiority of irinotecan/cisplatin over etoposide/cisplatin was suggested in small-cell lung cancer (SCLC). This trial investigated irinotecan/carboplatin (IP) versus etoposide/carboplatin (EP).The interim analysis at the phase II/phase III transition point of the multicenter trial is reported. Extensive disease SCLC patients were randomized to receive carboplatin AUC 5 mg x min/ml either in combination with 50 mg/m2 of irinotecan on days 1, 8 and 15 (IP) or with etoposide 140 mg/m2 days 1-3 (EP). The primary end point was response rate and the secondary end points were toxicity and progression-free survival.Seventy patients were randomized. Significant differences in grade 3 and 4 thrombo…
Effects of plantar flexor muscle fatigue induced by electromyostimulation on postural coordination
2007
International audience; The aim of the present study was to investigate the influence of a modification of an intrinsic capacity (plantar flexor strength) on the implementation of in-phase and anti-phase mode of coordination. Analysis of hip and ankle relative phases during fore-aft tracking task was done before and after an electromyostimulation fatigue protocol on the soleus muscles. Results showed participants used exclusively in-phase and anti-phase modes of coordination, with a sudden switch from one to the other with target frequency increase. Regarding tracking tasks, fatigue induces a decrease of performance for lower frequencies, and a significant decrease of switch frequency (−0.0…
"Baseline physical functioning status of metastatic colorectal cancer patients predicts the overall survival but not the activity of a front-line oxa…
2010
BACKGROUND: No differences in response rate (RR), progression-free survival (PFS), overall survival (OS) and quality of life (QoL) were seen in patients randomly treated with biweekly oxaliplatin plus either fluorouracil/folinic acid or capecitabine. METHODS: We investigated the independent effect of baseline clinical characteristics and physical functioning (PF) domain on RR, PFS, and OS in 310 patients who completed the EORTC QLQ-C30 questionnaire. Multivariate analyses stratified by treatment were performed. An exploratory analysis was done by grouping patients with a PF score superior or equal to the highest quartile (n = 111), included between the highest and the lowest quartiles (n = …
Meibomian glands structure in daily disposable soft contact lens wearers: a one‐year follow‐up study
2020
Purpose To assess the impact of daily disposable soft contact lenses on meibomian gland morphology over a period of 12 months. Methods Forty-one subjects (33 experienced and 8 neophytes) were fitted with either silicone-hydrogel or hydrogel daily contact lenses. The study protocol included four visits: baseline, day-2 for contact lens fit and follow-up measurements, as well as after 6 and 12 months of lens wear. Non-contact infrared meibography images were acquired with Keratograph 5M topographer (www.oculus.de) and analysed with an automated method, which objectively estimates the area of gland atrophy, gland length and width, number of glands and gland irregularity. Protocol at follow-up …
FOLFIRI with or without celecoxib in advanced colorectal cancer: a randomized phase II study of the Gruppo Oncologico dell'Italia Meridionale (GOIM)
2006
Background The aim of the study was to verify the efficacy and safety of the addition of celecoxib to FOLFIRI combination therapy in patients affected by advanced colorectal cancer. Patients and methods Eighty-one chemotherapy-naive patients entered in this randomized phase II trial of the GOIM (protocol no. 2301). Patients were randomized to receive FOLFIRI regimen (arm A): irinotecan 180 mg/m2 on day 1 with LV5FU2 regimen (LV at 100 mg/m2 administered as a 2-h infusion before FU at 400 mg/m2 as an intravenous bolus injection, and FU at 600 mg/m2 as a 22-h infusion immediately after 5-FU bolus injection on day 1 and 2); or FOLFIRI plus celecoxib 400 mg twice daily for 14 days (arm B). Both…
A randomized multicenter phase II study comparing capecitabine with irinotecan or cisplatin in metastatic adenocarcinoma of the stomach or esophagoga…
2009
The combination of irinotecan with 5-fluorouracil demonstrates efficacy with tolerable safety in the first-line treatment of metastatic gastroesophageal cancer (mGC). This randomized phase II trial compared for the first time capecitabine with irinotecan or cisplatin in this setting.Patients were randomly assigned to receive 3-week cycles of capecitabine 1000 mg/m(2), twice daily for 14 days, with on day 1 either irinotecan 250 mg/m(2) (XI) or cisplatin 80 mg/m(2) (XP). The primary end point was overall response rate (ORR) and secondary end points included progression-free survival (PFS), overall survival (OS) and safety.Of 118 patients recruited, 112 were eligible for safety analysis and 1…