Informações:
Falhas:
ID
16921
Descrição
Phase II Fixed Dose Rate Gemcitabine for Advanced or Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00220155
Link
https://clinicaltrials.gov/show/NCT00220155
Palavras-chave
Versões (1)
- 14/08/2016 14/08/2016 -
Transferido a
14 de agosto de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00220155
Eligibility Colorectal Cancer NCT00220155
- StudyEvent: Eligibility
Similar models
Eligibility Colorectal Cancer NCT00220155
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
age
Item
age >18 years
boolean
C0001779 (UMLS CUI [1])
colorectal adenocarcinoma
Item
histologically proven colorectal adenocarcinoma.
boolean
C0011900 (UMLS CUI [1,1])
C1319315 (UMLS CUI [1,2])
C1319315 (UMLS CUI [1,2])
locally advanced (inoperable) or metastatic colorectal carcinoma treated with at least one prior chemotherapy regimen.
Item
locally advanced (inoperable) or metastatic colorectal carcinoma treated with at least one prior chemotherapy regimen.
boolean
C0009402 (UMLS CUI [1,1])
C0677984 (UMLS CUI [1,2])
C0009402 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
C1514457 (UMLS CUI [3])
C0677984 (UMLS CUI [1,2])
C0009402 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
C1514457 (UMLS CUI [3])
progressive disease
Item
progressive disease documented by ct either during or within 3 months of completion of previous chemotherapy
boolean
C1335499 (UMLS CUI [1])
previous malignant disease
Item
no previous malignant disease other than non-melanotic skin cancer or carcinoma-in-situ of the uterine cervix.
boolean
C0260455 (UMLS CUI [1])
measurable disease
Item
unidimensional measurable disease as assessed by ct.
boolean
C1513041 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,2])
bone marrow function, hb, platelets, wbc, neutrophiles
Item
adequate bone marrow function; hb >10g/dl, platelets >100 x109/l, wbc >3x109/l, neut >1.5x109/l.
boolean
C0005953 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0005821 (UMLS CUI [3])
C0023508 (UMLS CUI [4])
C0200633 (UMLS CUI [5])
C0518015 (UMLS CUI [2])
C0005821 (UMLS CUI [3])
C0023508 (UMLS CUI [4])
C0200633 (UMLS CUI [5])
bilirubin
Item
adequate liver function: serum bilirubin <1.5 x upper limit of normal
boolean
C1278039 (UMLS CUI [1])
creatinine
Item
adequate renal function: serum creatinine < 0.11 mmol/l
boolean
C0201976 (UMLS CUI [1])
uncontrolled medical condition
Item
no concurrent uncontrolled medical conditions
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,2])
who performance status
Item
who performance status 0,1 or 2
boolean
C1298650 (UMLS CUI [1])
contraception
Item
adequate contraceptive precautions, if appropriate
boolean
C0700589 (UMLS CUI [1])
informed written consent
Item
informed written consent
boolean
C0021430 (UMLS CUI [1])
pragnancy
Item
negative pregnancy test in women of child bearing age
boolean
C0032961 (UMLS CUI [1])
life expectancy
Item
life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
medical or psychiatric condition that comprise the patient's ability to take informed consent.
Item
medical or psychiatric condition that comprise the patient's ability to take informed consent.
boolean
C0009488 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
C0004936 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
chemotherapy or radiotherapy
Item
patients within 4 weeks of chemotherapy or radiotherapy (6 weeks for nitrosureas or mitomycin c).
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C1522449 (UMLS CUI [2])
gemcitabine
Item
previous treatment with gemcitabine.
boolean
C0045093 (UMLS CUI [1])
uncontrolled cerebral metastases
Item
patients with uncontrolled cerebral metastases.
boolean
C0220650 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,2])