<?xml version="1.0" encoding="UTF-8"?> <!DOCTYPE Protocol > <Protocol id="CDR0000256224" LegacyPDQID="16746"><ProtocolIDs><Primary +ID><IDString>EORTC-06011</IDString></PrimaryID><OtherID><IDType>Alter +nate</IDType><IDString>SUPERGEN-EORTC-06011</IDString></OtherID><Othe +rID><IDType>Alternate</IDType><IDString>GMDSG-EORTC-06011</IDString>< +/OtherID><OtherID><IDType>ClinicalTrials.gov ID</IDType><IDString>NCT +00043134</IDString></OtherID><OtherID><IDType>Alternate</IDType><IDSt +ring>EudraCT-2005-002830</IDString></OtherID></ProtocolIDs><ProtocolS +ponsor>Other</ProtocolSponsor><ProtocolSponsor>Pharmaceutical/Industr +y</ProtocolSponsor><PDQProtocolTitle Audience="Professional">Phase II +I Randomized Study of Low-Dose Decitabine Versus Standard Supportive +Care in Elderly Patients With Myelodysplastic Syndromes </PDQProtocol +Title><PDQProtocolTitle Audience="Patient">Low-Dose Decitabine Compar +ed With Standard Supportive Care in Treating Older Patients With Myelodysplastic Syndrome</PDQProtocolTitl +e><ProtocolAbstract><Professional><Objectives><OrderedList Style="URo +man" id="_7"><ListItem>Compare the efficacy of low-dose decitabine vs + standard supportive care, in terms of overall survival, of elderly p +atients with myelodysplastic syndromes.</ListItem><ListItem>Compare t +he response rate and progression-free survival of patients treated wi +th these regimens.</ListItem><ListItem>Determine the toxicity of deci +tabine in these patients.</ListItem><ListItem>Assess the duration of +hospitalization and number of blood transfusions in patients treated +with these regimens.</ListItem><ListItem>Assess the quality of life o +f patients treated with these regimens.</ListItem></OrderedList></Obj +ectives><Outcome OutcomeType="Primary">Duration of overall survival</ +Outcome><Outcome OutcomeType="Secondary">Best response rate as measur +ed by Cheson response criteria </Outcome><Outcome OutcomeType="Second +ary">Overall progression-free survival </Outcome><Outcome OutcomeType +="Secondary">Toxicity as assessed by CTC v2.0</Outcome><Outcome Outco +meType="Secondary">Quality of life as assessed by EORTC QLQ30</Outcom +e><Outcome OutcomeType="Secondary">Days in Hospital</Outcome><Outline +><Para id="_8">This is a randomized, open-label, multicenter study. +Patients are stratified according to cytogenetic risk factors (good v +s poor vs intermediate vs unknown), disease (primary myelodysplastic +syndrome (MDS) vs secondary MDS), and participating center. Patients + with a successful cytogenetic exam are also stratified according to +overall International Prognostic Scoring System score (intermediate 1 + vs intermediate 2 vs high risk). Patients are randomized to 1 of 2 +treatment arms.</Para><ItemizedList Compact="No" Style="bullet" id="_ +40"><ListItem><Emphasis><Strong>Arm I: </Strong></Emphasis>Patients +receive decitabine IV over 4 hours every 8 hours for 3 days. Treatme +nt repeats every 6 weeks for 4-8 courses in the absence of disease pr +ogression or unacceptable toxicity.</ListItem><ListItem><Emphasis><St +rong>Arm II:</Strong></Emphasis> Patients receive standard supportiv +e care.</ListItem></ItemizedList><Para id="_11">Quality of life is as +sessed at baseline, every 6 weeks during therapy, every 2 months for +1 year, and then every 3 months thereafter.</Para><Para id="_12">Pati +ents are followed every 2 months for 1 year and then every 3 months t +hereafter.</Para></Outline><EntryCriteria><DiseaseCharacteristics><It +emizedList Compact="No" Style="bullet" id="_33"><ListItem>Diagnosis o +f primary or secondary myelodysplastic syndromes (MDS)<ItemizedList S +tyle="dash" id="_34"><ListItem>Any FAB or WHO criteria cellular type +allowed</ListItem></ItemizedList></ListItem><ListItem>Bone marrow bla +st count on aspiration or biopsy of 1 of the following:<ItemizedList +Style="dash" id="_36"><ListItem>No more than 10% with poor cytogeneti +c risk factors (defined as any numerical or structural abnormality of chromosome 7 and/or complex abnormaliti +es)</ListItem>
my $dbh = DBI->connect('dbi:AnyData:(RaiseError=>1)'); $dbh->func( 'XML', 'CDR256224.xml', 'CSV', 'testdbh.csv', 'ad_convert' +);
adConvert('XML', "$dir/CDR256224.xml", 'CSV',"$dir/testout.csv");
IDString,IDType,OtherID_IDString ,,
In reply to XML to CSV by Blue_eyed_son
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