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Treatment strategy in elderly patients with cancer


- candidate number15455
- NTR NumberNTR4186
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-sep-2013
- Secondary IDsNL42444.029.13 2013/164
- Public TitleTreatment strategy in elderly patients with cancer
- Scientific TitleOptimization of systemic treatment strategies in elderly patients with advanced solid Malignancies
- ACRONYMOptiMal
- hypothesisOur hypothesis is that assessment of bone marrow capacity reserve can predict treatment related toxicity.
- Healt Condition(s) or Problem(s) studied
- Inclusion criteria- Age older 70 years
- Diagnosis of advanced cancer of colorectum, breast or prostate
- Standard first line palliative treatment with cytotoxic agents will be started (Folfox, Xelox, capecitabine, paclitaxel or docetaxel)
- Estimated life expectancy 3 months
- Able to give informed consent
- WHO performance status 2
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the treatment and follow-up schedule; those conditions should be assessed with the patient before registration in the trial - No other severe medical or psychiatric conditions that in the judgment of the investigator renders the patient inappropriate for inclusion in this study. - Before patient registration, written informed consent must be given and documented to ICH/EUCGCP, national/local regulatory requirements and the local rules followed in our institution
- Exclusion criteria- Presence of cytopenia due to iron-, vitamin B12 and folic acid deficiency or hemolysis, unless adequately supplemented.
- Creatinine clearance 30 ml/min
- Serum AST and ALT 2.5 x ULN, in case of liver metastases serum AST and ALT 5 x ULN
- In case of therapy with Docetaxel/Paclitaxel serum bilirubin 1.5 x ULN
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jul-2013
- planned closingdate1-dec-2014
- Target number of participants85
- InterventionsAll patients will be submitted to blood tests, a bone marrow (BM) examination, and comprehensive geriatric assessment prior to start of treatment. A readily available CT scan will be used to measure lumbar skeletal muscle. In case of absence of a recent CT scan, a CT scan of the abdomen will be performed. In addition, limited pharmacokinetics (PK) will be performed.
- Primary outcome-Toxicity of treatment due to any cause
- Prevalence of MDS/IDUS in the studied group of patients
- Secondary outcome- Prevalence of sarcopenia in the studied group of patients
- (Termination, postponement or dose modification) of treatment due to any cause
- Overall survival - Response to treatment Progression free survival Difference in combination therapy versus monotherapy Quality of life Pharmacokinetics
- Timepointsfrom date of study inclusion until 30 days after end of treatment
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. dr. H.M.W. Verheul
- CONTACT for SCIENTIFIC QUERIESProf. dr. H.M.W. Verheul
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryThe purpose of this study is to assess whether the presence of a myelodysplastic syndrome, idiopathic cytopenia of undetermined significance (ICUS) or idiopathic dysplasia of undetermined significance (IDUS), correlates with treatment intensity and clinical outcome in older patients with advanced malignancies receiving palliative chemotherapy. We will study the relation between sarcopenia, comprehensive geriatric assessment en pharmacokinetics with treatment related toxicity as well. We hypothesize that a Comprehensive Geriatric Assessment with measurement of human body composition with computerized tomography and / or a standardized flow cytometry test to determine bone marrow capacity will provide an accurate tool to optimize treatment strategies in elderly patients with advanced malignancies
- Main changes (audit trail)
- RECORD24-sep-2013 - 2-okt-2013


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