View clinical trials related to Toxicity.
Filter by:On March 17th, 2011, the European Commission issued a marketing authorization valid throughout the European Union for Eribulin mesylate (Halaven; Eisai Limited), for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapic regimens for advanced disease. As the use of Eribulin will be widespread in this tumor setting, a better knowledge of its safety profile outside clinical trials is warranted. Indeed the possibility to select patients at risk for developing Eribulin-induced neuropathy, will allow the exclusion from these treatment of those patients harbouring the specific single nucleotide polymorphism (SNP). Given that Eribulin toxicity often results in treatment discontinuation, the ability to anticipate which patients will experience severe toxicity could allow for either early intervention or even possibly for prophylactic therapy, or for selection of the patients to be treated.
This Phase I evaluation of N-MCT in normal volunteers requires sequentially increased doses. At each dose level, the safety and pharmacokinetic will be measured. This Phase I trial will have the dose range of N-MCT from 200mg - 1200mg per patient.
The aim of this study is to evaluate efficacy and safety of Alpha Lipoic Acid(ALA) as an adjuvant in the management of patients with acute phosphide poisoning.
In this phase 1 trial, the investigators will prospectively evaluate 3 different external beam radiotherapy (EBRT) schedules. In every schedule, the whole bladder will be treated to 40 Gray (Gy) in 20 fractions, 5 fractions/week, 4 weeks in total. Based on the summation of abnormalities seen on pre- (initial tumor region) and post transurethral resection zone of fibrosis Diffusion weighted-magnetic resonance imaging (MRI) images the tumor region is delineated and defined as a gross tumor volume (GTV). The GTV will be treated using a simultaneous integrated boost (SIB): without extending the 4-weeks treatment period, 3 different dose levels will be implemented in order to increase the biological equivalent dose (BED), as muscle invasive bladder cancer has been shown to be dose-sensitive.
This study evaluate the association of body composition (mainly free-fat mass), clinical and biochemical parameters with development of toxicity in patients under treatment with Carboplatin/Paclitaxel in advanced NSCLC.
Scientists have developed an instrument which works like an "electronic nose". It is able to "sniff" smells and separate different smells by their electronic "signature". Studies using an electronic nose strongly suggest that smelling samples taken from humans (e.g. urine/ stool/ sweat/ tears) can identify different electronic smell signature from people with different diseases and in the future might be a new and easier way to diagnose serious conditions at an earlier stage. In a very small study, it has been successfully shown that using an electronic nose to sniff a stool sample does seem to identify people before they have had any radiotherapy - who will go on to get serious bowel side effects of radiotherapy. If this finding is correct, this is very important as it would allow the cancer doctors the option to change the way they give radiotherapy if they knew that a person was at very high risk of serious side effects from the treatment and to start treatment for the side effects at a much earlier stage. In this study the investigators want to confirm in a larger study whether the previous findings are correct, and to see whether similar results can be obtained by sniffing urine rather than stool (that would be much easier for everyone) and identify exactly which part of the complicated "smell" signature is different in the people who will get side effects. This may lead for the investigators to able to identify why people are making this specific smell and then do something about changing the smell before treatment starts. The likeliest cause for the production of a smell which predisposes to side effects is a specific group of germs living in the bowel. If these germs can be identified, then there are many possible ways of changing these germ populations in advance of radiotherapy. Enormous improvements have been made in treating cancer in recent years leading to hugely improved survival, however, treatment not infrequently can lead to side effects. Of all the possible long term physical side effects of cancer treatment, gastrointestinal (GI) symptoms are the most common and can have a great impact on daily activity. It is becoming increasingly clear that development of side effects in the bowel is not just related to the dose and way the radiotherapy is delivered.
The investigators will quantify inflammatory biomarkers in cerebrospinal fluid (CSF) and serum of children with hydrocephalus who are undergoing ventriculoperitoneal shunt placement under isoflurane anesthesia.
The investigators compare two-week course of chemoradiation (33 Gy in 10 fractions with oral capecitabine) and conventional chemoradiation (50.4 Gy in 28 fractions with 5-FU and leucovorin) in this randomized trial.
A radical cystectomy + extended pelvic lymph node dissection is considered to be the treatment of choice for patients with muscle invasive bladder cancer (MIBC). Despite this aggressive treatment the outcome is poor and ultimately, 30% of the patients with ≥pT3 tumors develop a pelvic recurrence. One- and 2-years survival for patients developing a local recurrence after cystectomy is only 8% and 3% respectively, with a median survival of <4 months. For patients with lymph node recurrence prognosis is somewhat better, but nevertheless still disappointing with reported 1- and 2 years survival of 42% and 11% respectively. The investigators hypothesize that an earlier implementation of external beam radiotherapy (EBRT) i.e. in the adjuvant setting, will prevent local and lymph node recurrence and improve disease free- and overall survival as local recurrence is linked to the development of distant metastasis. Adjuvant EBRT was tested in a prospective randomized trial and resulted in a 20% increase in 5-year disease free survival. Despite those impressive results, severe intestinal toxicity rates hampered the enthusiasm to use adjuvant EBRT, till now. In the last decade, great technological advancements in EBRT planning, such as intensity modulated arc therapy (IMAT), and positioning have been realised. This has resulted in a better coverage of the target volume while sparing normal tissue (mainly small bowel) and in a more precise delivery of the EBRT. Therefore, it is desirable to reconsider the use of adjuvant EBRT in selected MIBC patients.
Oesophagogastric cancer is a major cause of cancer related mortality, with an overall 5-year survival rate of 10% worldwide and patients are often diagnosed with locally advanced or metastasized disease at first presentation. For advanced oesophagogastric cancer fluoropyrimidines are the backbone of palliative chemotherapy and is commonly used in 2- or 3-drug combinations . However, in clinical practice after progression on first line therapy, a substantial number of oesophagogastric cancer patients may not be able to start second line chemotherapy due to rapid clinical deterioration. Therefore, new triplets with high anti-tumor activity and low toxicity are urgently needed. Given the activity of capecitabine and oxaliplatin containing regimens and the potential of taxanes in oesophagogastric cancer, the investigators propose a phase I study combining capecitabine and oxaliplatin with Nab-paclitaxel. Solvent-based taxanes (paclitaxel, docetaxel) can cause severe toxicities not only by the active agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane) is a solvent-free formulation of paclitaxel encapsulated in albumin. It does not require premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated hypersensitivity reactions. This new formulation improves safety profile, allows higher dosing with shorter infusion duration, and produces higher tumor drug concentration. It has proven activity in breast cancer, non small lung cancer and pancreatic cancer, as well as in gastric cancer models.