ID

28347

Beschrijving

Oxaliplatin and S-1 (OS) Versus Oxaliplatin and Capecitabine (XELOX) for Advanced Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00677144

Link

https://clinicaltrials.gov/show/NCT00677144

Trefwoorden

Versies (1)
  1. 05-01-18 05-01-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

5 januari 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Colorectal Neoplasm NCT00677144

Engels

Eligibility Colorectal Neoplasm NCT00677144

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed colorectal adenocarcinoma, initially diagnosed or recurred
Beschrijving

Adenocarcinoma of large intestine | Adenocarcinoma of large intestine Recurred

Datatype

boolean

Alias
UMLS CUI [1]
C1319315
UMLS CUI [2,1]
C1319315
UMLS CUI [2,2]
C0034897
unresectable, locally advanced or metastatic
Beschrijving

Adenocarcinoma of large intestine unresectable | Adenocarcinoma of large intestine Advanced Locally | Adenocarcinoma of large intestine metastatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319315
UMLS CUI [1,2]
C1519810
UMLS CUI [2,1]
C1319315
UMLS CUI [2,2]
C0205179
UMLS CUI [2,3]
C1517927
UMLS CUI [3,1]
C1319315
UMLS CUI [3,2]
C1522484
at least one uni-dimensional measurable lesion by recist criteria
Beschrijving

Measurable lesion Linear Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [1,3]
C1265611
age 18 to 75 years old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
estimated life expectancy ≥3 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance status ≤2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow function (wbcs ≥ 4,000/µl or absolute neutrophil count ≥
Beschrijving

Bone Marrow function | White Blood Cell Count procedure | Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0948762
1,500/µl, platelets ≥ 100,000/µl)
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
adequate kidney function (creatinine < 1.5 mg/dl)
Beschrijving

Renal function | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
adequate liver function (bilirubin < 2.0 mg/dl, transaminase levels <2.5 times the upper normal limit)
Beschrijving

Liver function | Serum total bilirubin measurement | Transaminases

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0919834
written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
other tumor type than adenocarcinoma
Beschrijving

Cancer Other | Exception Adenocarcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0001418
previous history of chemotherapy (exception : neoadjuvant or adjuvant chemotherapy without oxaliplatin)
Beschrijving

Prior Chemotherapy | Exception Neoadjuvant Chemotherapy Without Oxaliplatin | Exception Adjuvant Chemotherapy Without Oxaliplatin

Datatype

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C0600558
UMLS CUI [2,4]
C0332288
UMLS CUI [2,5]
C0069717
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0085533
UMLS CUI [3,3]
C0332288
UMLS CUI [3,4]
C0069717
presence of cns metastasis, psychosis, or seizure
Beschrijving

CNS metastases | Psychotic Disorders | Epilepsy

Datatype

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0033975
UMLS CUI [3]
C0014544
obvious bowel obstruction
Beschrijving

Intestinal Obstruction

Datatype

boolean

Alias
UMLS CUI [1]
C0021843
evidence of serious gastrointestinal bleeding
Beschrijving

Gastrointestinal Hemorrhage Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0017181
UMLS CUI [1,2]
C0205404
past or concurrent history of neoplasm other than colorectal adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
Beschrijving

Malignant Neoplasms | Exception Adenocarcinoma of large intestine | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1319315
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0851140
pregnant or lactating women, women of childbearing potential not employing adequate contraception
Beschrijving

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

Datatype

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
other serious illness or medical conditions
Beschrijving

Illness Serious | Other medical condition Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
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Similar models

Eligibility Colorectal Neoplasm NCT00677144

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of large intestine | Adenocarcinoma of large intestine Recurred
Item
histologically confirmed colorectal adenocarcinoma, initially diagnosed or recurred
boolean
C1319315 (UMLS CUI [1])
C1319315 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
Adenocarcinoma of large intestine unresectable | Adenocarcinoma of large intestine Advanced Locally | Adenocarcinoma of large intestine metastatic
Item
unresectable, locally advanced or metastatic
boolean
C1319315 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C1319315 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C1517927 (UMLS CUI [2,3])
C1319315 (UMLS CUI [3,1])
C1522484 (UMLS CUI [3,2])
Measurable lesion Linear Quantity
Item
at least one uni-dimensional measurable lesion by recist criteria
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Age
Item
age 18 to 75 years old
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
estimated life expectancy ≥3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status ≤2
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | White Blood Cell Count procedure | Absolute neutrophil count
Item
adequate bone marrow function (wbcs ≥ 4,000/µl or absolute neutrophil count ≥
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
Platelet Count measurement
Item
1,500/µl, platelets ≥ 100,000/µl)
boolean
C0032181 (UMLS CUI [1])
Renal function | Creatinine measurement, serum
Item
adequate kidney function (creatinine < 1.5 mg/dl)
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver function | Serum total bilirubin measurement | Transaminases
Item
adequate liver function (bilirubin < 2.0 mg/dl, transaminase levels <2.5 times the upper normal limit)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0919834 (UMLS CUI [3])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Exception Adenocarcinoma
Item
other tumor type than adenocarcinoma
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0001418 (UMLS CUI [2,2])
Prior Chemotherapy | Exception Neoadjuvant Chemotherapy Without Oxaliplatin | Exception Adjuvant Chemotherapy Without Oxaliplatin
Item
previous history of chemotherapy (exception : neoadjuvant or adjuvant chemotherapy without oxaliplatin)
boolean
C1514457 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0600558 (UMLS CUI [2,3])
C0332288 (UMLS CUI [2,4])
C0069717 (UMLS CUI [2,5])
C1705847 (UMLS CUI [3,1])
C0085533 (UMLS CUI [3,2])
C0332288 (UMLS CUI [3,3])
C0069717 (UMLS CUI [3,4])
CNS metastases | Psychotic Disorders | Epilepsy
Item
presence of cns metastasis, psychosis, or seizure
boolean
C0686377 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
C0014544 (UMLS CUI [3])
Intestinal Obstruction
Item
obvious bowel obstruction
boolean
C0021843 (UMLS CUI [1])
Gastrointestinal Hemorrhage Serious
Item
evidence of serious gastrointestinal bleeding
boolean
C0017181 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Adenocarcinoma of large intestine | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix
Item
past or concurrent history of neoplasm other than colorectal adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1319315 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0699893 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0851140 (UMLS CUI [4,3])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking
Item
pregnant or lactating women, women of childbearing potential not employing adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
Illness Serious | Other medical condition Serious
Item
other serious illness or medical conditions
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
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