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<?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>
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my $dbh = DBI->connect('dbi:AnyData:(RaiseError=>1)');
$dbh->func( 'XML', 'CDR256224.xml', 'CSV', 'testdbh.csv', 'ad_convert'
+);
- or download this
adConvert('XML', "$dir/CDR256224.xml", 'CSV',"$dir/testout.csv");
- or download this
IDString,IDType,OtherID_IDString
,,