ID

20186

Descripción

Feasibility Study of mFOLFOX6 in Patients With Advanced Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00209703

Link

https://clinicaltrials.gov/show/NCT00209703

Palabras clave

Versiones (1)
  1. 10/2/17 10/2/17 -
Subido en

10 de febrero de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00209703

Inglés

Eligibility Colorectal Cancer NCT00209703

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histological diagnosis of colorectral adenocarcinoma.
Descripción

Adenocarcinoma of large intestine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1319315
2. measurable or assessable lesions.
Descripción

Measurable Disease | Evaluable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
3. age: 15 ~ 75 years.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
4. performance status (ecog): 0 ~ 2.
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
5. prior chemotherapy within 2 regimens.
Descripción

Chemotherapy Regimen Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
6. adequate function of major organs (bone marrow, heart, lungs, liver etc.). wbc 3,500/mm3. hb 10.0 g/dl. platelet count 100,000/mm3. got and gpt 2.5times the upper limit of normal (excluding liver metastasis). t-bil 3.0mg/dl. creatinine within the upper limit of normal. normal ecg (not considering clinically unimportant arrhythmias and ischemic changes).
Descripción

Organ Function Major | Bone Marrow function | Cardiac function | Pulmonary function | Liver function | White Blood Cell Count procedure | Hemoglobin measurement | Platelet Count measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver | Serum total bilirubin measurement | Serum creatinine normal | ECG normal | Cardiac Arrhythmia | Ischemic Change

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1254358
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [3]
C0232164
UMLS CUI [4]
C0024119
UMLS CUI [5]
C0232741
UMLS CUI [6]
C0023508
UMLS CUI [7]
C0518015
UMLS CUI [8]
C0032181
UMLS CUI [9]
C0201899
UMLS CUI [10]
C0201836
UMLS CUI [11]
C0494165
UMLS CUI [12]
C1278039
UMLS CUI [13]
C0438244
UMLS CUI [14]
C0522054
UMLS CUI [15]
C0003811
UMLS CUI [16]
C2826576
(10) predicted survival for >8 weeks. (11) able to give written informed consent.
Descripción

Life Expectancy | Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. severe pleural effusion or ascites.
Descripción

Pleural effusion disorder Severe | Ascites Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032227
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0003962
UMLS CUI [2,2]
C0205082
2. metastasis to the central nervous system (cns).
Descripción

CNS metastases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0686377
3. active gastrointestinal bleeding.
Descripción

Gastrointestinal Hemorrhage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0017181
4. active infection.
Descripción

Communicable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
5. uncontrolled ischemic heart disease.
Descripción

Myocardial Ischemia Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C0205318
6. serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
Descripción

Complication Serious | Paralytic Ileus | Intestinal Obstruction | Pneumonia, Interstitial | Pulmonary Fibrosis | Diabetic - poor control | Heart failure | Kidney Failure | Liver Failure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0030446
UMLS CUI [3]
C0021843
UMLS CUI [4]
C0206061
UMLS CUI [5]
C0034069
UMLS CUI [6]
C0421258
UMLS CUI [7]
C0018801
UMLS CUI [8]
C0035078
UMLS CUI [9]
C0085605
7. active multiple cancer.
Descripción

Multiple malignancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0346429
8. severe mental disorder.
Descripción

Mental Disorders, Severe

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4046029
9. pregnancy, possible pregnancy, or breast-feeding.
Descripción

Pregnancy | Possible pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0425965
UMLS CUI [3]
C0006147
10. patients with neuropathy ≥ grade 2
Descripción

Neuropathy CTCAE Grades

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
11. judged to be ineligible for this protocol by the attending physician.
Descripción

Study Subject Participation Status Inappropriate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Colorectal Cancer NCT00209703

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of large intestine
Item
1. histological diagnosis of colorectral adenocarcinoma.
boolean
C1319315 (UMLS CUI [1])
Measurable Disease | Evaluable Disease
Item
2. measurable or assessable lesions.
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Age
Item
3. age: 15 ~ 75 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
4. performance status (ecog): 0 ~ 2.
boolean
C1520224 (UMLS CUI [1])
Chemotherapy Regimen Quantity
Item
5. prior chemotherapy within 2 regimens.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Organ Function Major | Bone Marrow function | Cardiac function | Pulmonary function | Liver function | White Blood Cell Count procedure | Hemoglobin measurement | Platelet Count measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver | Serum total bilirubin measurement | Serum creatinine normal | ECG normal | Cardiac Arrhythmia | Ischemic Change
Item
6. adequate function of major organs (bone marrow, heart, lungs, liver etc.). wbc 3,500/mm3. hb 10.0 g/dl. platelet count 100,000/mm3. got and gpt 2.5times the upper limit of normal (excluding liver metastasis). t-bil 3.0mg/dl. creatinine within the upper limit of normal. normal ecg (not considering clinically unimportant arrhythmias and ischemic changes).
boolean
C1254358 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0232164 (UMLS CUI [3])
C0024119 (UMLS CUI [4])
C0232741 (UMLS CUI [5])
C0023508 (UMLS CUI [6])
C0518015 (UMLS CUI [7])
C0032181 (UMLS CUI [8])
C0201899 (UMLS CUI [9])
C0201836 (UMLS CUI [10])
C0494165 (UMLS CUI [11])
C1278039 (UMLS CUI [12])
C0438244 (UMLS CUI [13])
C0522054 (UMLS CUI [14])
C0003811 (UMLS CUI [15])
C2826576 (UMLS CUI [16])
Life Expectancy | Informed Consent
Item
(10) predicted survival for >8 weeks. (11) able to give written informed consent.
boolean
C0023671 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pleural effusion disorder Severe | Ascites Severe
Item
1. severe pleural effusion or ascites.
boolean
C0032227 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0003962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
CNS metastases
Item
2. metastasis to the central nervous system (cns).
boolean
C0686377 (UMLS CUI [1])
Gastrointestinal Hemorrhage
Item
3. active gastrointestinal bleeding.
boolean
C0017181 (UMLS CUI [1])
Communicable Disease
Item
4. active infection.
boolean
C0009450 (UMLS CUI [1])
Myocardial Ischemia Uncontrolled
Item
5. uncontrolled ischemic heart disease.
boolean
C0151744 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Complication Serious | Paralytic Ileus | Intestinal Obstruction | Pneumonia, Interstitial | Pulmonary Fibrosis | Diabetic - poor control | Heart failure | Kidney Failure | Liver Failure
Item
6. serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
boolean
C0009566 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0030446 (UMLS CUI [2])
C0021843 (UMLS CUI [3])
C0206061 (UMLS CUI [4])
C0034069 (UMLS CUI [5])
C0421258 (UMLS CUI [6])
C0018801 (UMLS CUI [7])
C0035078 (UMLS CUI [8])
C0085605 (UMLS CUI [9])
Multiple malignancy
Item
7. active multiple cancer.
boolean
C0346429 (UMLS CUI [1])
Mental Disorders, Severe
Item
8. severe mental disorder.
boolean
C4046029 (UMLS CUI [1])
Pregnancy | Possible pregnancy | Breast Feeding
Item
9. pregnancy, possible pregnancy, or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0425965 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Neuropathy CTCAE Grades
Item
10. patients with neuropathy ≥ grade 2
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Study Subject Participation Status Inappropriate
Item
11. judged to be ineligible for this protocol by the attending physician.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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