Información:
Error:
ID
12458
Descripción
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
Palabras clave
Versiones (1)
- 20/11/15 20/11/15 -
Subido en
20 de noviembre de 2015
DOI
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Licencia
Creative Commons BY 4.0
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Eligibility Neoplasms, Colorectal NCT01157052
Eligibility Neoplasms, Colorectal NCT01157052
- StudyEvent: Eligibility
Similar models
Eligibility Neoplasms, Colorectal NCT01157052
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
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])
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])
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])
C0430061 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Life Expectancy
Item
life expectancy longer that 6 months
boolean
C0023671 (UMLS CUI [1])
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])
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])
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