ID

28309

Descrição

OPTIMOX1 in Chinese mCRC Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01023633

Link

https://clinicaltrials.gov/show/NCT01023633

Palavras-chave

  1. 03/01/2018 03/01/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

3 de janeiro de 2018

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Colorectal Cancer NCT01023633

Eligibility Colorectal Cancer NCT01023633

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically confirmed adenocarcinoma of the colon or rectum
Descrição

Adenocarcinoma of colon | Adenocarcinoma of rectum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0338106
UMLS CUI [2]
C0149978
unresectable metastases
Descrição

Neoplasm Metastasis unresectable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1519810
at least one bidimensionally measurable lesion of ≥ 1 cm
Descrição

Measurable lesion 2-Dimensional Size Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [1,3]
C0449453
UMLS CUI [1,4]
C1265611
no previous chemotherapy for metastatic disease; completed at least more than 1 year oxaliplatin therapy for adjuvant treatment
Descrição

Absence Prior Chemotherapy Neoplasm Metastasis | Adjuvant therapy Completed | oxaliplatin

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1514457
UMLS CUI [1,3]
C0027627
UMLS CUI [2,1]
C0677850
UMLS CUI [2,2]
C0205197
UMLS CUI [3]
C0069717
18-75 years old
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
ecog 0-2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy greater than 3 months
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
hemogram: wbc≥4.0 x109/l, anc ≥2 x109/l, plt ≥100 x109/l, hb ≥90g/l,
Descrição

Hemogram | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0200631
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0518015
adequate renal function
Descrição

Renal function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232804
adequate liver function
Descrição

Liver function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232741
signed informed consent before the treatment
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with previous oxaliplatin based adjuvant chemotherapy within 1 year
Descrição

Adjuvant Chemotherapy Oxaliplatin Based

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0069717
UMLS CUI [1,3]
C1705938
completely or partially bowel obstruction
Descrição

Intestinal Obstruction Complete | Partial bowel obstruction

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021843
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C1328480
presence of peripheral neuropathy (ctc>grade i)
Descrição

Peripheral Neuropathy CTCAE Grades

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
severe mental disorder
Descrição

Mental Disorders, Severe

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4046029
cns metastasis
Descrição

CNS metastases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0686377
with other severe disease: uncontrolled active infectious disease, uncontrolled hypertension, heart infarction within 1 year, uncontrolled high-risk arrhythmia, unstable angina
Descrição

Disease Severe | Communicable Disease Uncontrolled | Uncontrolled hypertension | Myocardial Infarction | Cardiac Arrhythmia High risk Uncontrolled | Angina, Unstable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C1868885
UMLS CUI [4]
C0027051
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C0332167
UMLS CUI [5,3]
C0205318
UMLS CUI [6]
C0002965
with other malignant disease previously or concurrently
Descrição

Cancer Other

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1707251
receive other anti-tumor treatment
Descrição

Cancer treatment Other

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
pregnant or lactating women, or women of child bearing potential without contraceptive method.
Descrição

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332268

Similar models

Eligibility Colorectal Cancer NCT01023633

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of colon | Adenocarcinoma of rectum
Item
patients with histologically confirmed adenocarcinoma of the colon or rectum
boolean
C0338106 (UMLS CUI [1])
C0149978 (UMLS CUI [2])
Neoplasm Metastasis unresectable
Item
unresectable metastases
boolean
C0027627 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
Measurable lesion 2-Dimensional Size Quantity
Item
at least one bidimensionally measurable lesion of ≥ 1 cm
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C0449453 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Absence Prior Chemotherapy Neoplasm Metastasis | Adjuvant therapy Completed | oxaliplatin
Item
no previous chemotherapy for metastatic disease; completed at least more than 1 year oxaliplatin therapy for adjuvant treatment
boolean
C0332197 (UMLS CUI [1,1])
C1514457 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0677850 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0069717 (UMLS CUI [3])
Age
Item
18-75 years old
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy greater than 3 months
boolean
C0023671 (UMLS CUI [1])
Hemogram | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
hemogram: wbc≥4.0 x109/l, anc ≥2 x109/l, plt ≥100 x109/l, hb ≥90g/l,
boolean
C0200631 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0518015 (UMLS CUI [5])
Renal function
Item
adequate renal function
boolean
C0232804 (UMLS CUI [1])
Liver function
Item
adequate liver function
boolean
C0232741 (UMLS CUI [1])
Informed Consent
Item
signed informed consent before the treatment
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Adjuvant Chemotherapy Oxaliplatin Based
Item
patients with previous oxaliplatin based adjuvant chemotherapy within 1 year
boolean
C0085533 (UMLS CUI [1,1])
C0069717 (UMLS CUI [1,2])
C1705938 (UMLS CUI [1,3])
Intestinal Obstruction Complete | Partial bowel obstruction
Item
completely or partially bowel obstruction
boolean
C0021843 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1328480 (UMLS CUI [2])
Peripheral Neuropathy CTCAE Grades
Item
presence of peripheral neuropathy (ctc>grade i)
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Mental Disorders, Severe
Item
severe mental disorder
boolean
C4046029 (UMLS CUI [1])
CNS metastases
Item
cns metastasis
boolean
C0686377 (UMLS CUI [1])
Disease Severe | Communicable Disease Uncontrolled | Uncontrolled hypertension | Myocardial Infarction | Cardiac Arrhythmia High risk Uncontrolled | Angina, Unstable
Item
with other severe disease: uncontrolled active infectious disease, uncontrolled hypertension, heart infarction within 1 year, uncontrolled high-risk arrhythmia, unstable angina
boolean
C0012634 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1868885 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0332167 (UMLS CUI [5,2])
C0205318 (UMLS CUI [5,3])
C0002965 (UMLS CUI [6])
Cancer Other
Item
with other malignant disease previously or concurrently
boolean
C1707251 (UMLS CUI [1])
Cancer treatment Other
Item
receive other anti-tumor treatment
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking
Item
pregnant or lactating women, or women of child bearing potential without contraceptive method.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])

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