Informações:
Falhas:
ID
20186
Descrição
Feasibility Study of mFOLFOX6 in Patients With Advanced Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00209703
Link
https://clinicaltrials.gov/show/NCT00209703
Palavras-chave
Versões (1)
- 10/02/2017 10/02/2017 -
Transferido a
10 de fevereiro de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00209703
Eligibility Colorectal Cancer NCT00209703
- StudyEvent: Eligibility
Similar models
Eligibility Colorectal Cancer NCT00209703
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
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])
C0021430 (UMLS CUI [2])
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])
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])
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])
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])
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])
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])
C1548788 (UMLS CUI [1,2])