ID

28129

Beschreibung

Thalidomide and Tegafur/Uracil(UFUR) in the Treatment of Advanced Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00890188

Link

https://clinicaltrials.gov/show/NCT00890188

Stichworte

Versionen (1)
  1. 20.12.17 20.12.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. Dezember 2017

DOI

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Creative Commons BY 4.0
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Eligibility Colon Cancer NCT00890188

Englisch

Eligibility Colon Cancer NCT00890188

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed colorectal carcinoma
Beschreibung

Colorectal Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0009402
patients must have received at least one oxaliplatin-contained chemotherapy before the study and did not want to receive or tolerate irinotecan- contained chemotherapy
Beschreibung

Chemotherapy Containing Oxaliplatin Quantity | Unwilling Chemotherapy Containing Irinotecan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0069717
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C0558080
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C0332256
UMLS CUI [2,4]
C0123931
presence of at least one measurable disease which is defined as lesion that can be measured in at least 1 dimension as 20 mm with conventional ct or 10 mm with spiral ct scan
Beschreibung

Measurable Disease Quantity | Measurement Dimensions Quantity | Measurable Disease Size CT | Measurable Disease Size Spiral CT

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0242485
UMLS CUI [2,2]
C0439534
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0456389
UMLS CUI [3,3]
C0040405
UMLS CUI [4,1]
C1513041
UMLS CUI [4,2]
C0456389
UMLS CUI [4,3]
C0860888
age ≥ 18 year, ecog performance status 0, 1, 2, 3
Beschreibung

Age | ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1520224
white blood cell (wbc) ≥ 3,000/mm3, absolute neutrophil count (anc) ≥ 1,500/mm3, platelets ≥ 100,000/mm3 and hemoglobin ≥ 8 mg / dl
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
serum creatinine level 2.0 mg/dl or lower
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
serum bilirubin less than 1.5 times the upper limit of normal range (uln)
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
alanine aminotransferase (alt) or aspartate aminotransferase (ast) less than 2.5 times the uln if no demonstrable liver metastases or less than 5 times the uln in the presence of liver metastases
Beschreibung

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver

Datentyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0494165
require to wait 28 days before entry onto the study after being treated with any immunotherapy, or biologic systemic (including any target therapy)
Beschreibung

Immunotherapy | Biological treatment Systemic | Targeted Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0021083
UMLS CUI [2,1]
C1531518
UMLS CUI [2,2]
C0205373
UMLS CUI [3]
C2985566
written informed consent to participate in the trial
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of cns metastasis
Beschreibung

CNS metastases

Datentyp

boolean

Alias
UMLS CUI [1]
C0686377
other malignancy with the exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to the entry of study
Beschreibung

Cancer Other | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0851140
less than 4 weeks since previous treatment
Beschreibung

Prior Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1514463
concomitant illness that might be aggregated by chemotherapy. for examples, active, non-controlled infection or other active, non-controlled disease such as congestive heart failure, angina pectoris, respiratory insufficiency, arrhythmia. it depends on investigation's decision.
Beschreibung

Comorbidity | Chemotherapy | Communicable Disease Uncontrolled | Disease Uncontrolled | Congestive heart failure | Angina Pectoris | Respiratory Insufficiency | Cardiac Arrhythmia

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0392920
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205318
UMLS CUI [5]
C0018802
UMLS CUI [6]
C0002962
UMLS CUI [7]
C0035229
UMLS CUI [8]
C0003811
women of child-bearing potential without using a reliable and appropriate contraceptive method during study period
Beschreibung

Childbearing Potential Contraceptive methods Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332268
pre existent sensory or motor neurotoxicity > grade 2 according to national cancer institute (nci) common toxicity criteria (ctc) (disabling paresthesia and/or significant motor loss)
Beschreibung

Neurotoxicity Sensory Pre-existing CTCAE Grades | Neurotoxicity Motor Pre-existing CTCAE Grades | Paresthesia Disabling condition | Loss of motor functions

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0235032
UMLS CUI [1,2]
C0445254
UMLS CUI [1,3]
C2347662
UMLS CUI [1,4]
C1516728
UMLS CUI [2,1]
C0235032
UMLS CUI [2,2]
C0501384
UMLS CUI [2,3]
C2347662
UMLS CUI [2,4]
C1516728
UMLS CUI [3,1]
C0030554
UMLS CUI [3,2]
C4061999
UMLS CUI [4]
C1864672
patients who are receiving other concomitant chemotherapy, radiotherapy or any other investigational therapy
Beschreibung

Chemotherapy | Therapeutic radiology procedure | Therapy, Investigational

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0949266
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Ähnliche Modelle

Eligibility Colon Cancer NCT00890188

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma
Item
histologically or cytologically confirmed colorectal carcinoma
boolean
C0009402 (UMLS CUI [1])
Chemotherapy Containing Oxaliplatin Quantity | Unwilling Chemotherapy Containing Irinotecan
Item
patients must have received at least one oxaliplatin-contained chemotherapy before the study and did not want to receive or tolerate irinotecan- contained chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0069717 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0558080 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0332256 (UMLS CUI [2,3])
C0123931 (UMLS CUI [2,4])
Measurable Disease Quantity | Measurement Dimensions Quantity | Measurable Disease Size CT | Measurable Disease Size Spiral CT
Item
presence of at least one measurable disease which is defined as lesion that can be measured in at least 1 dimension as 20 mm with conventional ct or 10 mm with spiral ct scan
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0242485 (UMLS CUI [2,1])
C0439534 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1513041 (UMLS CUI [3,1])
C0456389 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C1513041 (UMLS CUI [4,1])
C0456389 (UMLS CUI [4,2])
C0860888 (UMLS CUI [4,3])
Age | ECOG performance status
Item
age ≥ 18 year, ecog performance status 0, 1, 2, 3
boolean
C0001779 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
white blood cell (wbc) ≥ 3,000/mm3, absolute neutrophil count (anc) ≥ 1,500/mm3, platelets ≥ 100,000/mm3 and hemoglobin ≥ 8 mg / dl
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Creatinine measurement, serum
Item
serum creatinine level 2.0 mg/dl or lower
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement
Item
serum bilirubin less than 1.5 times the upper limit of normal range (uln)
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver
Item
alanine aminotransferase (alt) or aspartate aminotransferase (ast) less than 2.5 times the uln if no demonstrable liver metastases or less than 5 times the uln in the presence of liver metastases
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
Immunotherapy | Biological treatment Systemic | Targeted Therapy
Item
require to wait 28 days before entry onto the study after being treated with any immunotherapy, or biologic systemic (including any target therapy)
boolean
C0021083 (UMLS CUI [1])
C1531518 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C2985566 (UMLS CUI [3])
Informed Consent
Item
written informed consent to participate in the trial
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
CNS metastases
Item
presence of cns metastasis
boolean
C0686377 (UMLS CUI [1])
Cancer Other | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix
Item
other malignancy with the exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to the entry of study
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0699893 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
Prior Therapy
Item
less than 4 weeks since previous treatment
boolean
C1514463 (UMLS CUI [1])
Comorbidity | Chemotherapy | Communicable Disease Uncontrolled | Disease Uncontrolled | Congestive heart failure | Angina Pectoris | Respiratory Insufficiency | Cardiac Arrhythmia
Item
concomitant illness that might be aggregated by chemotherapy. for examples, active, non-controlled infection or other active, non-controlled disease such as congestive heart failure, angina pectoris, respiratory insufficiency, arrhythmia. it depends on investigation's decision.
boolean
C0009488 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0009450 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0018802 (UMLS CUI [5])
C0002962 (UMLS CUI [6])
C0035229 (UMLS CUI [7])
C0003811 (UMLS CUI [8])
Childbearing Potential Contraceptive methods Lacking
Item
women of child-bearing potential without using a reliable and appropriate contraceptive method during study period
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Neurotoxicity Sensory Pre-existing CTCAE Grades | Neurotoxicity Motor Pre-existing CTCAE Grades | Paresthesia Disabling condition | Loss of motor functions
Item
pre existent sensory or motor neurotoxicity > grade 2 according to national cancer institute (nci) common toxicity criteria (ctc) (disabling paresthesia and/or significant motor loss)
boolean
C0235032 (UMLS CUI [1,1])
C0445254 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
C0235032 (UMLS CUI [2,1])
C0501384 (UMLS CUI [2,2])
C2347662 (UMLS CUI [2,3])
C1516728 (UMLS CUI [2,4])
C0030554 (UMLS CUI [3,1])
C4061999 (UMLS CUI [3,2])
C1864672 (UMLS CUI [4])
Chemotherapy | Therapeutic radiology procedure | Therapy, Investigational
Item
patients who are receiving other concomitant chemotherapy, radiotherapy or any other investigational therapy
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0949266 (UMLS CUI [3])
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