In a phase I study, we determined the maximum tolerated dose (MTD) and the recommended dose (RD) of nedaplatin (CDGP) in combination chemotherapy with Docetaxel (DOC) and 5-fluorouracil (5-FU) for treatment of carcinoma of the head and neck. Then, in a phase II study, we examined the efficacy and safety of the RD of chemotherapy. Fresh patients with squamous cell carcinoma of the head and neck were enrolled in the study. The dosage of chemotherapy was as follows: DOC 60 mg/m(2) on day 1 by infusion over 2 hours; CDGP 20-30 mg/m(2)/day on day 1 to 5 by infusion over 1 hour, and 5-FU 600 mg/m(2)/day on day 1 to 5 by 5 days continuous infusion. For CDGP, an initial dose level was set at 20 mg/m(2), and 3 patients were enrolled for each level of dose escalation. The DLT was defined here as grade 4 neutropenia or grade> or =3 non-hematotoxic reactions. The dose at which DLT was observed in overall 33% cases was taken as MTD. The RD for phase II study was estimated to be DOC 60 mg/m(2), CDGP 20 mg/m(2)/day, 5-FU 600 mg/m(2)/day. Forty patients were enrolled in the phase II study. DLT of neutropenia was noted in 2 of 38 cases. DLT of non-hematotoxic reactions was found in less than 33% of the cases; 17 cases showed CR, and 12 cases showed PR. The response rate was 76.3%. The overall response rate in histological assessment was 55.3%. The combination chemotherapy with Low-Divided Dose of CDGP, DOC and 5-FU was suggested to be safe and effective.
Download full-text PDF |
Source |
|---|
Publication Analysis
Top Keywords
Similar Publications
Development and application of a clinical core data set for deep brain stimulation in Parkinson's disease, dystonia or tremor: from data collection to data exchange and data sharing.
Neurol Res Pract
January 2025
Institute of Clinical Epidemiology and Biometry, Julius-Maximilians-Universität Würzburg (JMU), Haus D7, Josef-Schneider-Straße 2, 97080, Würzburg, Germany.
Background: Comprehensive clinical data regarding factors influencing the individual disease course of patients with movement disorders treated with deep brain stimulation might help to better understand disease progression and to develop individualized treatment approaches.
Methods: The clinical core data set was developed by a multidisciplinary working group within the German transregional collaborative research network ReTune. The development followed standardized methodology comprising review of available evidence, a consensus process and performance of the first phase of the study.
The PROPHECI trial: a phase II, double-blind, placebo-controlled, randomized clinical trial for the treatment of pseudoxanthoma elasticum with oral pyrophosphate.
Trials
January 2025
Université Côte d'Azur, CNRS, LP2M, Nice, France.
Background: /aims. Pseudoxanthoma Elasticum (PXE, OMIM 264800) is an autosomal, recessive, metabolic disorder characterized by progressive ectopic calcification in the skin, the vasculature and Bruch's membrane. Variants in the ABCC6 gene are associated with low plasma pyrophosphate (PPi) concentration.
View Article and Find Full Text PDFTAD-SIE: sample size estimation for clinical randomized controlled trials using a Trend-Adaptive Design with a Synthetic-Intervention-Based Estimator.
Trials
January 2025
Department of Electrical and Computer Engineering, Princeton University, Princeton, 08544, NJ, USA.
Background: Phase-3 clinical trials provide the highest level of evidence on drug safety and effectiveness needed for market approval by implementing large randomized controlled trials (RCTs). However, 30-40% of these trials fail mainly because such studies have inadequate sample sizes, stemming from the inability to obtain accurate initial estimates of average treatment effect parameters.
Methods: To remove this obstacle from the drug development cycle, we present a new algorithm called Trend-Adaptive Design with a Synthetic-Intervention-Based Estimator (TAD-SIE) that powers a parallel-group trial, a standard RCT design, by leveraging a state-of-the-art hypothesis testing strategy and a novel trend-adaptive design (TAD).
Investigating impact of consulting midwives on maternal rights charter on perception of respectful maternity care and postpartum blues among postpartum women: a quasi-experimental study.
BMC Med Ethics
January 2025
Department of Midwifery, Nursing and Midwifery Faculty, Bushehr University of Medical Sciences, Bushehr, Iran.
Introduction: Despite the existing reports on mistreatment and disrespectful maternal care, few studies have investigated interventions to mitigate this issue. The present study aims to assess the impact of consulting midwives on maternal rights charter on perception of respectful maternity care and postpartum blues among postpartum women in two hospitals in southern Iran.
Methodology: This quasi-experimental study was conducted on 437 postpartum women (217 mothers before the intervention and 220 mothers after the intervention) and 44 midwives working in the maternity ward of two hospitals affiliated to Bushehr University of Medical Sciences in 2023-2024.
Perceived healthiness of sugary drinks and related social norms among adults in five countries: evidence from the International Food Policy Study.
Nutr J
January 2025
École de nutrition, Faculté des sciences de l'agriculture et de l'alimentation (FSAA), Université Laval, 2440, boulevard Hochelaga, Québec, Québec, G1V 0A6, Canada.
Background: A better understanding of correlates of sugary drink consumption is essential to inform public health interventions. This study examined differences in perceived healthiness of sugary drinks and related social norms between countries, over time, and sociodemographic groups and associations with sugary drink intake.
Methods: This study used annual cross-sectional data from the International Food Policy Study from 2018 to 2021 in Australia, Canada, the United Kingdom, the United States, and Mexico.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!