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ID

12458

Beskrivning

Oxaliplatin Pharmacokinetics With and Without Ca2+/MG2+ Infusion in Colorectal Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01157052

Länk

https://clinicaltrials.gov/show/NCT01157052

Nyckelord

  1. 2015-11-20 2015-11-20 -
Uppladdad den

20 november 2015

DOI

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Creative Commons BY 4.0

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    Eligibility Neoplasms, Colorectal NCT01157052

    Eligibility Neoplasms, Colorectal NCT01157052

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    patients must have metastatic colorectal cancer (stage iv)
    Beskrivning

    Metastatic colorectal cancer

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0948380 (undefined)
    patients who were treated with 5fu and leucovorin in the adjuvant setting or with 5fu and leucovorin (lv)or/and folfiri regimen for metastatic setting may be eligible for this trial.
    Beskrivning

    LEUCOVORIN TREATMENT

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0745700 (LEUCOVORIN TREATMENT)
    patients must be ≥ 18 years
    Beskrivning

    Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    patients must have an eastern cooperative oncology group (ecog) performance status of 0 to 2
    Beskrivning

    ECOG performance status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    patients must have adequate renal function of creatinine < 1.5mg/dl and a creatinine clearance > 45ml/min. patients must have adequate hepatic function with a bilirubin > 1.5 mg/dl and ast (normal range 0-14/l) and alt (normal range 0-49 u/l) in the absence of liver metastasis or </= 5x the upper limit of normal of ast and alt in the presence of liver metastasis.
    Beskrivning

    Renal function and hepatic function

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0232804 (Renal function)
    SNOMED
    11953005
    LOINC
    LP31398-8
    UMLS CUI [2]
    C0232741 (Liver function)
    SNOMED
    79036002
    LOINC
    LP31397-0
    patients must have adequate bone marrow function with absolute neutrophil count(anc)≥
    Beskrivning

    Bone marrow function

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0005953 (Bone Marrow)
    SNOMED
    279729006
    LOINC
    LP7410-6
    1,500/цl and platelets ≥ 100,000/цl and a hemoglobin ≥ 10g/d.
    Beskrivning

    Platelets and hemoglobin hemoglobin

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032181 (Platelet Count measurement)
    SNOMED
    61928009
    UMLS CUI [2]
    C0518015 (Hemoglobin measurement)
    patients must be willing and able to comply with the study protocol for the study duration and patients must give written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.
    Beskrivning

    Informed Consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment. also,women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. the investigator is requested to advise the patient how to achieve an adequate contraception.
    Beskrivning

    Women of childbearing potential

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3831118 (Childbearing Potential)
    UMLS CUI [2]
    C0430061 (Serum pregnancy test negative)
    SNOMED
    166435006
    UMLS CUI [3]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    life expectancy longer that 6 months
    Beskrivning

    Life Expectancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671 (Life Expectancy)
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    patients who have received oxaliplatin previously
    Beskrivning

    Oxaliplatin

    Datatyp

    boolean

    patients with known peripheral neuropathy ≥ grade 2 according to the who scale
    Beskrivning

    Peripheral neuropathy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0031117 (Peripheral Neuropathy)
    patients who have tested positive for hiv
    Beskrivning

    HIV+

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019699 (HIV Seropositivity)
    SNOMED
    165816005
    patients with other significant medical, psychiatric disorders that, in the opinion of the investigator, will exclude the patient from the study for compliance of safety reasons.
    Beskrivning

    Significant medical, psychiatric disorders

    Datatyp

    boolean

    patients who cannot swallow
    Beskrivning

    Patients who cannot swallow

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3899712 (Cannot Swallow Certain Solid Foods)
    history of known allergy to oxaliplatin or other platinum compounds,to 5-fu, to lv, or to any ingredients in the formulations or the containers
    Beskrivning

    Allergy to oxaliplatin or other platinum compounds

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0069717 (oxaliplatin)
    SNOMED
    327032007
    UMLS CUI [2,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [2,2]
    C3536919 (Platinum Compounds)
    SNOMED
    11996000
    participation in another clinical trial with any investigational drug within 30 days prior to study screening
    Beskrivning

    Participation in another clinical trial

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    pernicious anemia or other megaloblastic anemia with vitamin b12 deficiency
    Beskrivning

    Pernicious anemia or other megaloblastic anemia

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0002892 (Anemia, Pernicious)
    SNOMED
    84027009
    UMLS CUI [2]
    C0002888 (Anemia, Megaloblastic)
    SNOMED
    53165003
    patient with concomitant treatment with drugs/ingredients reported to have a potential activity to prevent peripheral sensory neuropathy (psn)
    Beskrivning

    Sensory neuropathy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0151313 (Sensory neuropathy)
    SNOMED
    789588003
    patients who haven't successfully completed local therapy for previously treated cns metastases & who haven't been discontinued with corticosteroid for >4kws before starting chemotherapy. patients with asymptomatic brain mets who have no evidence of midline shift on ct/mri may be enrolled without initiation of local therapy for the cns mets. repeat scan must be performed < 4wks to ensure no progression.
    Beskrivning

    Previously treated cns metastases

    Datatyp

    boolean

    Similar models

    Eligibility Neoplasms, Colorectal NCT01157052

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Metastatic colorectal cancer
    Item
    patients must have metastatic colorectal cancer (stage iv)
    boolean
    C0948380 (UMLS CUI [1])
    LEUCOVORIN TREATMENT
    Item
    patients who were treated with 5fu and leucovorin in the adjuvant setting or with 5fu and leucovorin (lv)or/and folfiri regimen for metastatic setting may be eligible for this trial.
    boolean
    C0745700 (UMLS CUI [1])
    Age
    Item
    patients must be ≥ 18 years
    boolean
    C0001779 (UMLS CUI [1])
    ECOG performance status
    Item
    patients must have an eastern cooperative oncology group (ecog) performance status of 0 to 2
    boolean
    C1520224 (UMLS CUI [1])
    Renal function and hepatic function
    Item
    patients must have adequate renal function of creatinine < 1.5mg/dl and a creatinine clearance > 45ml/min. patients must have adequate hepatic function with a bilirubin > 1.5 mg/dl and ast (normal range 0-14/l) and alt (normal range 0-49 u/l) in the absence of liver metastasis or </= 5x the upper limit of normal of ast and alt in the presence of liver metastasis.
    boolean
    C0232804 (UMLS CUI [1])
    C0232741 (UMLS CUI [2])
    Bone marrow function
    Item
    patients must have adequate bone marrow function with absolute neutrophil count(anc)≥
    boolean
    C0005953 (UMLS CUI [1])
    Platelets and hemoglobin hemoglobin
    Item
    1,500/цl and platelets ≥ 100,000/цl and a hemoglobin ≥ 10g/d.
    boolean
    C0032181 (UMLS CUI [1])
    C0518015 (UMLS CUI [2])
    Informed Consent
    Item
    patients must be willing and able to comply with the study protocol for the study duration and patients must give written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.
    boolean
    C0021430 (UMLS CUI [1])
    Women of childbearing potential
    Item
    women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment. also,women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. the investigator is requested to advise the patient how to achieve an adequate contraception.
    boolean
    C3831118 (UMLS CUI [1])
    C0430061 (UMLS CUI [2])
    C0700589 (UMLS CUI [3])
    Life Expectancy
    Item
    life expectancy longer that 6 months
    boolean
    C0023671 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Oxaliplatin
    Item
    patients who have received oxaliplatin previously
    boolean
    Peripheral neuropathy
    Item
    patients with known peripheral neuropathy ≥ grade 2 according to the who scale
    boolean
    C0031117 (UMLS CUI [1])
    HIV+
    Item
    patients who have tested positive for hiv
    boolean
    C0019699 (UMLS CUI [1])
    Significant medical, psychiatric disorders
    Item
    patients with other significant medical, psychiatric disorders that, in the opinion of the investigator, will exclude the patient from the study for compliance of safety reasons.
    boolean
    Patients who cannot swallow
    Item
    patients who cannot swallow
    boolean
    C3899712 (UMLS CUI [1])
    Allergy to oxaliplatin or other platinum compounds
    Item
    history of known allergy to oxaliplatin or other platinum compounds,to 5-fu, to lv, or to any ingredients in the formulations or the containers
    boolean
    C0020517 (UMLS CUI [1,1])
    C0069717 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C3536919 (UMLS CUI [2,2])
    Participation in another clinical trial
    Item
    participation in another clinical trial with any investigational drug within 30 days prior to study screening
    boolean
    C2348568 (UMLS CUI [1])
    Pernicious anemia or other megaloblastic anemia
    Item
    pernicious anemia or other megaloblastic anemia with vitamin b12 deficiency
    boolean
    C0002892 (UMLS CUI [1])
    C0002888 (UMLS CUI [2])
    Sensory neuropathy
    Item
    patient with concomitant treatment with drugs/ingredients reported to have a potential activity to prevent peripheral sensory neuropathy (psn)
    boolean
    C0151313 (UMLS CUI [1])
    Previously treated cns metastases
    Item
    patients who haven't successfully completed local therapy for previously treated cns metastases & who haven't been discontinued with corticosteroid for >4kws before starting chemotherapy. patients with asymptomatic brain mets who have no evidence of midline shift on ct/mri may be enrolled without initiation of local therapy for the cns mets. repeat scan must be performed < 4wks to ensure no progression.
    boolean

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