ID

12458

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01157052

Trefwoorden

  1. 20-11-15 20-11-15 -
Geüploaded op

20 november 2015

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :


    Geen commentaren

    U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

    Eligibility Neoplasms, Colorectal NCT01157052

    Eligibility Neoplasms, Colorectal NCT01157052

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

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

    Metastatic colorectal cancer

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0948380
    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.
    Beschrijving

    LEUCOVORIN TREATMENT

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0745700
    patients must be ≥ 18 years
    Beschrijving

    Age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    patients must have an eastern cooperative oncology group (ecog) performance status of 0 to 2
    Beschrijving

    ECOG performance status

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    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.
    Beschrijving

    Renal function and hepatic function

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0232804
    UMLS CUI [2]
    C0232741
    patients must have adequate bone marrow function with absolute neutrophil count(anc)≥
    Beschrijving

    Bone marrow function

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0005953
    1,500/цl and platelets ≥ 100,000/цl and a hemoglobin ≥ 10g/d.
    Beschrijving

    Platelets and hemoglobin hemoglobin

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032181
    UMLS CUI [2]
    C0518015
    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.
    Beschrijving

    Informed Consent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    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.
    Beschrijving

    Women of childbearing potential

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3831118
    UMLS CUI [2]
    C0430061
    UMLS CUI [3]
    C0700589
    life expectancy longer that 6 months
    Beschrijving

    Life Expectancy

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients who have received oxaliplatin previously
    Beschrijving

    Oxaliplatin

    Datatype

    boolean

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

    Peripheral neuropathy

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0031117
    patients who have tested positive for hiv
    Beschrijving

    HIV+

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    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.
    Beschrijving

    Significant medical, psychiatric disorders

    Datatype

    boolean

    patients who cannot swallow
    Beschrijving

    Patients who cannot swallow

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3899712
    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
    Beschrijving

    Allergy to oxaliplatin or other platinum compounds

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0069717
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C3536919
    participation in another clinical trial with any investigational drug within 30 days prior to study screening
    Beschrijving

    Participation in another clinical trial

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    pernicious anemia or other megaloblastic anemia with vitamin b12 deficiency
    Beschrijving

    Pernicious anemia or other megaloblastic anemia

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0002892
    UMLS CUI [2]
    C0002888
    patient with concomitant treatment with drugs/ingredients reported to have a potential activity to prevent peripheral sensory neuropathy (psn)
    Beschrijving

    Sensory neuropathy

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0151313
    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.
    Beschrijving

    Previously treated cns metastases

    Datatype

    boolean

    Similar models

    Eligibility Neoplasms, Colorectal NCT01157052

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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

    Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

    Velden gemarkeerd met een * zijn verplicht.

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial