Linked Life Data

1826960

Source:http://linkedlifedata.com/resource/pubmed/id/1826960

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:dateCreated
1991-5-30
pubmed:abstractText
A group of 6 European cancer centers, coordinated by the Institut Gustave-Roussy, began a phase II trial of the radiosensitizing drug, etanidazole, in November 1986. The trial was designed to study the toxicity of the drug and the feasibility of a phase III trial on the combination of etanidazole with radiotherapy for treating head and neck squamous cell carcinomas. Thirty-one patients were included in the phase II trial between November 1986 and June 1987; 25 completed the whole course of treatment. Most of the neuropathies occurred during the two weeks following radiotherapy, but had no major effect on radiotherapy itself. The area under the curve (AUC) was measured in 22 patients; there was no correlation between total AUC and the incidence of neuropathy, although there was a trend towards more neuropathies at high total AUC. The toxicity of Eta did not appear excessive. A phase III trial was therefore begun in July 1987. Twenty-nine centers in 5 European countries (France, Italy, Germany, Austria and the UK) took part. A total of 330 patients had been enrolled by the end of November 1989. This report presents the results available to date. 15% of the patients treated with Eta plus radiotherapy have received less than 15 Eta injections, mainly because of skin rashes (5%), peripheral neuropathies (3%) or patient refusal (3%). The overall frequency of neuropathies was 27%, but most were grade I and occur mainly after treatment. There were similar percentages of radiotherapy-related toxicities, mainly acute reactions in irradiated normal tissues, in both Eta and control arms.(ABSTRACT TRUNCATED AT 250 WORDS)
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:issn
0167-8140
pubmed:author
pubmed:issnType
Print
pubmed:volume
20 Suppl 1
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
121-7
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed:year
1991
pubmed:articleTitle
Progress report of a phase II and a phase III trial with etanidazole (SR-2508): a multicentre European study.
pubmed:affiliation
Département des Radiations (Unité Inserm 287), Villejuif, France.
pubmed:publicationType
Journal Article, Clinical Trial, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Multicenter Study