ID

32484

Description

First-line Therapy of Stage IV Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00784446

Lien

https://clinicaltrials.gov/show/NCT00784446

Mots-clés

Versions (1)
  1. 04/11/2018 04/11/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

4 novembre 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Stage IV Colorectal Cancer NCT00784446

Anglais

Eligibility Stage IV Colorectal Cancer NCT00784446

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven inoperable colorectal cancer
Description

Colorectal Carcinoma Inoperable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C0205187
adult patients >= 18 years of age
Description

Adult | Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
ecog <2
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
preceding chemo- or immunotherapy with the exception of adjuvant or neoadjuvant treatment of non-metastatic disease ending ≥ 6 month prior to study inclusion. progression within 6 month after the end of adjuvant therapy must be excluded.
Description

Chemotherapy | Immunotherapy | Exception Adjuvant therapy Non-Metastatic Neoplasm | Exception Neoadjuvant Therapy Non-Metastatic Neoplasm | Disease Progression

Type de données

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0021083
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0677850
UMLS CUI [3,3]
C1334991
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0600558
UMLS CUI [4,3]
C1334991
UMLS CUI [5]
C0242656
other malignancies with the exception of basal cell carcinoma or successfully treated carcinoma in situ of the cervix uteri.
Description

Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix Treated Successful

Type de données

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1522326
UMLS CUI [3,4]
C1272703
no history of severe comorbidities, i. e. uncontrolled hypertension, gi-bleeding, congestive heart-failure nyha class ii-iv, symptomatic coronary heart disease, myocardial infarction within 1 year prior to study inclusion, serious cardiac arrhythmias requiring medication, grade ii or greater peripheral vascular disease and other severe uncontrolled co-morbidities
Description

Comorbidity Severe | Uncontrolled hypertension | Gastrointestinal Hemorrhage | Congestive heart failure New York Heart Association Classification | Coronary heart disease Symptomatic | Myocardial Infarction | Cardiac Arrhythmia Serious Requirement Pharmaceutical Preparations | Peripheral Vascular Diseases CTCAE Grades | Comorbidity Severe Uncontrolled

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0017181
UMLS CUI [4,1]
C0018802
UMLS CUI [4,2]
C1275491
UMLS CUI [5,1]
C0010068
UMLS CUI [5,2]
C0231220
UMLS CUI [6]
C0027051
UMLS CUI [7,1]
C0003811
UMLS CUI [7,2]
C0205404
UMLS CUI [7,3]
C1514873
UMLS CUI [7,4]
C0013227
UMLS CUI [8,1]
C0085096
UMLS CUI [8,2]
C1516728
UMLS CUI [9,1]
C0009488
UMLS CUI [9,2]
C0205082
UMLS CUI [9,3]
C0205318
no history of stroke or other cns-diseases (tumors, seizure, transient ischemic attack etc.)
Description

Cerebrovascular accident | CNS disorder | Malignant Neoplasms | Seizures | Transient Ischemic Attack

Type de données

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007682
UMLS CUI [3]
C0006826
UMLS CUI [4]
C0036572
UMLS CUI [5]
C0007787
≥ grade ii peripheral artery vascular occlusive disease
Description

Peripheral arterial occlusive disease CTCAE Grades

Type de données

boolean

Alias
UMLS CUI [1,1]
C1306889
UMLS CUI [1,2]
C1516728
preexisting neuropathy ≥ grade 1
Description

Neuropathy Pre-existing CTCAE Grades

Type de données

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
interstitial pneumonia or lung fibrosis
Description

Pneumonia, Interstitial | Pulmonary Fibrosis

Type de données

boolean

Alias
UMLS CUI [1]
C0206061
UMLS CUI [2]
C0034069
serious, nonhealing wound, ulcer, or bone fracture
Description

Wound Non-healing Serious | Ulcer | Fracture

Type de données

boolean

Alias
UMLS CUI [1,1]
C0043250
UMLS CUI [1,2]
C0205301
UMLS CUI [1,3]
C0205404
UMLS CUI [2]
C0041582
UMLS CUI [3]
C0016658
preceding irradiation an indicator lesion except for documented progressive disease during irradiation and termination of irradiation ≥ 4 weeks from study inclusion
Description

Therapeutic radiology procedure Indicator Lesion | Exception Progressive Disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1522602
UMLS CUI [1,3]
C0221198
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1335499
thromboembolic or bleeding events within the last 6 month
Description

Thromboembolism | Event Hemorrhagic

Type de données

boolean

Alias
UMLS CUI [1]
C0040038
UMLS CUI [2,1]
C0441471
UMLS CUI [2,2]
C0333275
need for therapeutic anticoagulation (heparin, cumarin)
Description

Patient need for Anticoagulation Therapy | heparin | coumarin

Type de données

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0003281
UMLS CUI [2]
C0019134
UMLS CUI [3]
C0010206
use of ass > 325 mg/die or nsar
Description

ASS U/day | NSAR

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0456683
UMLS CUI [2]
C0068238
proteinuria > 1+ (stix) as long as urine protein >1g/24h
Description

Proteinuria | Urine protein test

Type de données

boolean

Alias
UMLS CUI [1]
C0033687
UMLS CUI [2]
C0262923
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Similar models

Eligibility Stage IV Colorectal Cancer NCT00784446

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma Inoperable
Item
histologically proven inoperable colorectal cancer
boolean
C0009402 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
Adult | Age
Item
adult patients >= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
ECOG performance status
Item
ecog <2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Immunotherapy | Exception Adjuvant therapy Non-Metastatic Neoplasm | Exception Neoadjuvant Therapy Non-Metastatic Neoplasm | Disease Progression
Item
preceding chemo- or immunotherapy with the exception of adjuvant or neoadjuvant treatment of non-metastatic disease ending ≥ 6 month prior to study inclusion. progression within 6 month after the end of adjuvant therapy must be excluded.
boolean
C0392920 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0677850 (UMLS CUI [3,2])
C1334991 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0600558 (UMLS CUI [4,2])
C1334991 (UMLS CUI [4,3])
C0242656 (UMLS CUI [5])
Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix Treated Successful
Item
other malignancies with the exception of basal cell carcinoma or successfully treated carcinoma in situ of the cervix uteri.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1272703 (UMLS CUI [3,4])
Comorbidity Severe | Uncontrolled hypertension | Gastrointestinal Hemorrhage | Congestive heart failure New York Heart Association Classification | Coronary heart disease Symptomatic | Myocardial Infarction | Cardiac Arrhythmia Serious Requirement Pharmaceutical Preparations | Peripheral Vascular Diseases CTCAE Grades | Comorbidity Severe Uncontrolled
Item
no history of severe comorbidities, i. e. uncontrolled hypertension, gi-bleeding, congestive heart-failure nyha class ii-iv, symptomatic coronary heart disease, myocardial infarction within 1 year prior to study inclusion, serious cardiac arrhythmias requiring medication, grade ii or greater peripheral vascular disease and other severe uncontrolled co-morbidities
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2])
C0017181 (UMLS CUI [3])
C0018802 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C0010068 (UMLS CUI [5,1])
C0231220 (UMLS CUI [5,2])
C0027051 (UMLS CUI [6])
C0003811 (UMLS CUI [7,1])
C0205404 (UMLS CUI [7,2])
C1514873 (UMLS CUI [7,3])
C0013227 (UMLS CUI [7,4])
C0085096 (UMLS CUI [8,1])
C1516728 (UMLS CUI [8,2])
C0009488 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C0205318 (UMLS CUI [9,3])
Cerebrovascular accident | CNS disorder | Malignant Neoplasms | Seizures | Transient Ischemic Attack
Item
no history of stroke or other cns-diseases (tumors, seizure, transient ischemic attack etc.)
boolean
C0038454 (UMLS CUI [1])
C0007682 (UMLS CUI [2])
C0006826 (UMLS CUI [3])
C0036572 (UMLS CUI [4])
C0007787 (UMLS CUI [5])
Peripheral arterial occlusive disease CTCAE Grades
Item
≥ grade ii peripheral artery vascular occlusive disease
boolean
C1306889 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Neuropathy Pre-existing CTCAE Grades
Item
preexisting neuropathy ≥ grade 1
boolean
C0442874 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Pneumonia, Interstitial | Pulmonary Fibrosis
Item
interstitial pneumonia or lung fibrosis
boolean
C0206061 (UMLS CUI [1])
C0034069 (UMLS CUI [2])
Wound Non-healing Serious | Ulcer | Fracture
Item
serious, nonhealing wound, ulcer, or bone fracture
boolean
C0043250 (UMLS CUI [1,1])
C0205301 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0041582 (UMLS CUI [2])
C0016658 (UMLS CUI [3])
Therapeutic radiology procedure Indicator Lesion | Exception Progressive Disease
Item
preceding irradiation an indicator lesion except for documented progressive disease during irradiation and termination of irradiation ≥ 4 weeks from study inclusion
boolean
C1522449 (UMLS CUI [1,1])
C1522602 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1335499 (UMLS CUI [2,2])
Thromboembolism | Event Hemorrhagic
Item
thromboembolic or bleeding events within the last 6 month
boolean
C0040038 (UMLS CUI [1])
C0441471 (UMLS CUI [2,1])
C0333275 (UMLS CUI [2,2])
Patient need for Anticoagulation Therapy | heparin | coumarin
Item
need for therapeutic anticoagulation (heparin, cumarin)
boolean
C0686904 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C0019134 (UMLS CUI [2])
C0010206 (UMLS CUI [3])
ASS U/day | NSAR
Item
use of ass > 325 mg/die or nsar
boolean
C0004057 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0068238 (UMLS CUI [2])
Proteinuria | Urine protein test
Item
proteinuria > 1+ (stix) as long as urine protein >1g/24h
boolean
C0033687 (UMLS CUI [1])
C0262923 (UMLS CUI [2])
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