Search results for "Protocol"
showing 10 items of 1808 documents
Phase I dose-escalation of trifluridine/tipiracil in combination with oxaliplatin in patients with metastatic colorectal cancer
2019
Abstract Background and objectives Pre-clinical data have shown that combining trifluridine/tipiracil with oxaliplatin enhances anti-tumour activity compared with either monotherapy. A phase I dose-escalation study was conducted to determine the maximum tolerated dose (MTD), recommended dose (RD) for phase II and pharmacokinetic profile of this combination in patients with metastatic colorectal cancer (mCRC) who had progressed after at least 1 prior line of treatment. Methods Using a 3 + 3 design, patients received escalating trifluridine/tipiracil doses from 25, then 30 and to 35 mg/m2 twice daily, days 1–5, q14 days, together with a fixed dose of 85 mg/m2 of oxaliplatin day 1, q14 days. A…
Sequence variation in mature microRNA-608 and benefit from neo-adjuvant treatment in locally advanced rectal cancer patients
2016
Summary Analysis of a polymorphism in mature microRNA-608 (rs4919510) in rectal cancer patients enrolled in a randomized phase II clinical trial identified patient subpopulations who might benefit from the use of an intensified neo-adjuvant treatment strategy with Cetuximab.
A Phase I dose-escalation study of third-line regorafenib with trifluridine/tipiracil in metastatic colorectal cancer
2021
Aim: To determine a recommended Phase II dose of the oral fluoropyrimidine trifluridine/tipiracil (FTD/TPI) combined with the multi-kinase inhibitor regorafenib (REG) in refractory metastatic colorectal cancer patients. Materials & methods: A conventional 3 + 3 dose finding design was used. FTD/TPI was administered on days 1–5 and 8–12 of a 28-day cycle, REG on days 2–22. Two dose levels were used: FTD/TPI 25 mg/m2 b.i.d. + REG 120 mg/d, then escalated to FTD/TPI 35 mg/m2 b.i.d. + REG 120 mg/d. Results: In total, 12 patients were treated at two dose levels. Three dose-limiting toxicities were observed; all were grade 3 hypertension causally attributed to REG. Recommended Phase II dose …
A Phase I–II Study on the Toxicity and Therapeutic Efficacy of 5-Fluorouracil in Combination with Leucovorin and Cisplatinum in Patients with Advance…
1990
5-Fluorouracil (5-FU) has been the treatment of choice for colorectal carcinoma with an overall response rate of about 20%. Recent studies have shown that folate (LV) can increase 5-FU therapeutic efficacy, achieving about a 40% response rate without a clear impact on survival. Cisplatinum (CDDP) is usually inactive in colorectal carcinoma, but the association with 5-FU results in a synergistic antineoplastic effect. A phase I-II study was done to assess the maximally tolerated dose (MTD) of CDDP in association with 5-FU + LV. The MTD for CDDP was 20 mg/m2/wk in association with 5-FU 400-500 mg/m2/wk and LV 500 mg/m2/wk. WHO criteria were used for evaluation of both toxicity and response. I…
Cytokeratin-18 fragments predict treatment response and overall survival in gastric cancer in a randomized controlled trial
2018
Background:Gastric cancer is common malignancy and exhibits a poor prognosis. At the time of diagnosis, the majority of patients present with metastatic disease which precludes curative treatment. Non-invasive biomarkers which discriminate early from advanced stages or predict the response to treatment are urgently required. This study explored the cytokeratin-18 fragment M30 and full-length cytokeratin-18 M65 in predicting treatment response and survival in a randomized, placebo-controlled trial of advanced gastric cancer.Methods:Patients enrolled in the SUN-CASE study received sunitinib or placebo as an adjunct to standard therapy with leucovorin (Ca-folinate), 5-fluorouracil, and irinote…
A Phase I Study of Cisplatinum plus 5-Fluorouracil in Modulation with Citrovorum Factor in Metastatic Colorectal Carcinoma
1991
A phase I study of 5-fluorouracil 600 mg/m2/week and folinic acid 500 mg/m2/week on day 1 and cisplatin administered weekly on day 2 was carried out on 30 patients with metastatic colorectal carcinoma of which 20 patients were pretreated with 5-fluorouracil. The first group of patients received cisplatin at the dose of 5 mg/m2/week. Cisplatin was then escalated to 10, 15, 20, 25, 30, and 35 mg/m2/week for subsequent groups of patients. Gastrointestinal side-effects were the dose-limiting toxicity. A therapy related death was seen at the dose of 35 mg/m2/week of cisplatin. The maximally tolerated dose of cisplatin in combination with 5-fluorouracil and citrovorum factor is 20 mg/m2/week. The…
An adaptive virtual reality system for the treatment of adjustment disorder and complicated grief: 1-year follow-up efficacy data.
2019
This is the pre-peer reviewed version of the following article: An adaptive virtual reality system for the treatment of adjustment disorder and complicated grief: 1‐year follow‐up efficacy data, which has been published in final form at https://doi.org/10.1002/cpp.2342. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions. Adjustment disorder (AD) and complicated grief (CG) are serious mental conditions that have a high prevalence and are associated with significant impairments in social and work functioning. Recently, these categories have been better specified in the new ICD‐11 proposal. Empirical research on …
Large scale and information effects on cooperation in public good games
2019
AbstractThe problem of public good provision is central in economics and touches upon many challenging societal issues, ranging from climate change mitigation to vaccination schemes. However, results which are supposed to be applied to a societal scale have only been obtained with small groups of people, with a maximum group size of 100 being reported in the literature. This work takes this research to a new level by carrying out and analysing experiments on public good games with up to 1000 simultaneous players. The experiments are carried out via an online protocol involving daily decisions for extended periods. Our results show that within those limits, participants’ behaviour and collec…
Evaluation of the prognostic role of tumour-associated macrophages in newly diagnosed classical hodgkin lymphoma and correlation with early FDG-PET a…
2017
In Hodgkin Lymphoma (HL), about 20% of patients still have relapsed/refractory disease and late toxic effects rate continue to rise with time. 'Early FDG-PET' and tissue macrophage infiltration (TAM) emerged as powerful prognostic predictors. The primary endpoint was to investigate the prognostic role of both early FDG-PET and TAM; the secondary endpoint was to test if early FDG-PET positivity could correlate with high TAM score. A cohort of 200 HL patients was analysed. Induction treatment plan consisted of two to six courses of ABVD and, if indicated, involved field radiation therapy. All patients repeated CT scan and FDG-PET after two cycles and after the completion of therapy. TAM in di…
Mandibular trauma treatment: a comparison of two protocols
2014
Objectives: The aim of this study was to evaluate the treatment of mandibular fractures treated in two European centre in 10 years. Study Design: This study is based on 2 systematic computer-assisted databases that have continuously recorded patients hospitalized with maxillofacial fractures in two centers in Turin, Italy and in Amsterdam, the Netherlands for ten years. Only patients who were admitted for mandibular fractures were considered for this study. Results: Between 2001 and 2010, a total of 752 patients were admitted at Turin hospital with a total of 1167 mandibular fractures not associated with further maxillofacial fractures, whereas 245 patients were admitted at Amsterdam hospit…