EORTC-06011AlternateSUPERGEN-EORTC-06011AlternateGMDSG-EORTC-06011ClinicalTrials.gov IDNCT00043134AlternateEudraCT-2005-002830OtherPharmaceutical/IndustryPhase III Randomized Study of Low-Dose Decitabine Versus Standard Supportive Care in Elderly Patients With Myelodysplastic Syndromes Low-Dose Decitabine Compared With Standard Supportive Care in Treating Older Patients With Myelodysplastic SyndromeCompare the efficacy of low-dose decitabine vs standard supportive care, in terms of overall survival, of elderly patients with myelodysplastic syndromes.Compare the response rate and progression-free survival of patients treated with these regimens.Determine the toxicity of decitabine in these patients.Assess the duration of hospitalization and number of blood transfusions in patients treated with these regimens.Assess the quality of life of patients treated with these regimens.Duration of overall survivalBest response rate as measured by Cheson response criteria Overall progression-free survival Toxicity as assessed by CTC v2.0Quality of life as assessed by EORTC QLQ30Days in HospitalThis is a randomized, open-label, multicenter study. Patients are stratified according to cytogenetic risk factors (good vs 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.Arm I: Patients receive decitabine IV over 4 hours every 8 hours for 3 days. Treatment repeats every 6 weeks for 4-8 courses in the absence of disease progression or unacceptable toxicity.Arm II: Patients receive standard supportive care.Quality of life is assessed at baseline, every 6 weeks during therapy, every 2 months for 1 year, and then every 3 months thereafter.Patients are followed every 2 months for 1 year and then every 3 months thereafter.Diagnosis of primary or secondary myelodysplastic syndromes (MDS)Any FAB or WHO criteria cellular type allowedBone marrow blast count on aspiration or biopsy of 1 of the following:No more than 10% with poor cytogenetic risk factors (defined as any numerical or structural abnormality of chromosome 7 and/or complex abnormalities) #### 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 ,,