ID

20201

Beschrijving

Randomized Phase III Study of Folfiri+Avastin Versus Xeliri+Avastin as 1st Line Treatment of CRC; ODM derived from: https://clinicaltrials.gov/show/NCT00469443

Link

https://clinicaltrials.gov/show/NCT00469443

Trefwoorden

Versies (1)
  1. 12-02-17 12-02-17 -
Geüploaded op

12 februari 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Colorectal Cancer NCT00469443

Engels

Eligibility Colorectal Cancer NCT00469443

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed locally advanced or metastatic colorectal cancer
Beschrijving

Colorectal Carcinoma Advanced Local | Colorectal cancer metastatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0205276
UMLS CUI [2]
C0948380
measurable or evaluable disease
Beschrijving

Measurable Disease | Evaluable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
ecog performance status ≤ 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
age 18 - 72 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
adequate liver (bilirubin ≤ 1.5 unl, sgot/sgpt ≤ 4 unl, alp ≤ 2.5 unl), renal (creatinine ≤ 1.5 unl) and bone marrow (anc ≥ 1,500/mm3, plt ≥ 100,000/mm3) function
Beschrijving

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Renal function | Creatinine measurement, serum | Bone Marrow function | Absolute neutrophil count | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201850
UMLS CUI [6]
C0232804
UMLS CUI [7]
C0201976
UMLS CUI [8,1]
C0005953
UMLS CUI [8,2]
C0031843
UMLS CUI [9]
C0948762
UMLS CUI [10]
C0032181
patients with history of hemoptysis or with increased risk of thromboembolic events should be observed carefully due to administration of avastin
Beschrijving

Hemoptysis | Thromboembolism Risk Increased | Avastin Administration Observation

Datatype

boolean

Alias
UMLS CUI [1]
C0019079
UMLS CUI [2,1]
C0040038
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C0205217
UMLS CUI [3,1]
C1135130
UMLS CUI [3,2]
C1533734
UMLS CUI [3,3]
C0700325
patients must be able to understand the nature of this study
Beschrijving

Comprehension Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous 1st line chemotherapy
Beschrijving

First line Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0392920
adjuvant chemotherapy with irinotecan regimen with relapse < 6 months after the completion
Beschrijving

Irinotecan Adjuvant Chemotherapy | Recurrent disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0123931
UMLS CUI [1,2]
C0085533
UMLS CUI [2]
C0277556
active infection
Beschrijving

Communicable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
history of serious cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
Beschrijving

Heart Disease Serious | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Ventricular arrhythmia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0085612
previous radiotherapy within the last 4 weeks or > 25% of bone marrow
Beschrijving

Therapeutic radiology procedure | Therapeutic radiology procedure Bone Marrow Percentage

Datatype

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0005953
UMLS CUI [2,3]
C0439165
patients with unstable cns metastases
Beschrijving

CNS metastases Unstable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0443343
patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction
Beschrijving

Chronic diarrhea | Partial bowel obstruction

Datatype

boolean

Alias
UMLS CUI [1]
C0401151
UMLS CUI [2]
C1328480
second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
Beschrijving

Second Primary Cancers | Skin carcinoma | Carcinoma in situ of uterine cervix

Datatype

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0851140
psychiatric illness or social situation that would preclude study compliance
Beschrijving

Mental disorder Protocol Compliance Exclusion | Social situation Protocol Compliance Exclusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C2828389
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C2828389
pregnant or lactating women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients > 65 years with history of arterial thromboembolic, myocardial infarction, unstable angina and pulmonary embolism
Beschrijving

Age | Arterial thromboembolism | Myocardial Infarction | Angina, Unstable | Pulmonary Embolism

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C3544094
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0034065
Terug naar het begin van de pagina

Similar models

Eligibility Colorectal Cancer NCT00469443

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma Advanced Local | Colorectal cancer metastatic
Item
histologically confirmed locally advanced or metastatic colorectal cancer
boolean
C0009402 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0948380 (UMLS CUI [2])
Measurable Disease | Evaluable Disease
Item
measurable or evaluable disease
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Age
Item
age 18 - 72 years
boolean
C0001779 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Renal function | Creatinine measurement, serum | Bone Marrow function | Absolute neutrophil count | Platelet Count measurement
Item
adequate liver (bilirubin ≤ 1.5 unl, sgot/sgpt ≤ 4 unl, alp ≤ 2.5 unl), renal (creatinine ≤ 1.5 unl) and bone marrow (anc ≥ 1,500/mm3, plt ≥ 100,000/mm3) function
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
C0232804 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
C0005953 (UMLS CUI [8,1])
C0031843 (UMLS CUI [8,2])
C0948762 (UMLS CUI [9])
C0032181 (UMLS CUI [10])
Hemoptysis | Thromboembolism Risk Increased | Avastin Administration Observation
Item
patients with history of hemoptysis or with increased risk of thromboembolic events should be observed carefully due to administration of avastin
boolean
C0019079 (UMLS CUI [1])
C0040038 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0205217 (UMLS CUI [2,3])
C1135130 (UMLS CUI [3,1])
C1533734 (UMLS CUI [3,2])
C0700325 (UMLS CUI [3,3])
Comprehension Study Protocol
Item
patients must be able to understand the nature of this study
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
First line Chemotherapy
Item
previous 1st line chemotherapy
boolean
C1708063 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Irinotecan Adjuvant Chemotherapy | Recurrent disease
Item
adjuvant chemotherapy with irinotecan regimen with relapse < 6 months after the completion
boolean
C0123931 (UMLS CUI [1,1])
C0085533 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2])
Communicable Disease
Item
active infection
boolean
C0009450 (UMLS CUI [1])
Heart Disease Serious | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Ventricular arrhythmia
Item
history of serious cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0085612 (UMLS CUI [5])
Therapeutic radiology procedure | Therapeutic radiology procedure Bone Marrow Percentage
Item
previous radiotherapy within the last 4 weeks or > 25% of bone marrow
boolean
C1522449 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0005953 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
CNS metastases Unstable
Item
patients with unstable cns metastases
boolean
C0686377 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Chronic diarrhea | Partial bowel obstruction
Item
patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction
boolean
C0401151 (UMLS CUI [1])
C1328480 (UMLS CUI [2])
Second Primary Cancers | Skin carcinoma | Carcinoma in situ of uterine cervix
Item
second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
boolean
C0751623 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
Mental disorder Protocol Compliance Exclusion | Social situation Protocol Compliance Exclusion
Item
psychiatric illness or social situation that would preclude study compliance
boolean
C0004936 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Age | Arterial thromboembolism | Myocardial Infarction | Angina, Unstable | Pulmonary Embolism
Item
patients > 65 years with history of arterial thromboembolic, myocardial infarction, unstable angina and pulmonary embolism
boolean
C0001779 (UMLS CUI [1])
C3544094 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0034065 (UMLS CUI [5])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial