ID

28322

Descripción

A Study of Avastin (Bevacizumab) With XELOX or FOLFOX in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line FOLFIRI and Avastin; ODM derived from: https://clinicaltrials.gov/show/NCT01077739

Link

https://clinicaltrials.gov/show/NCT01077739

Palabras clave

Versiones (1)
  1. 4/1/18 4/1/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

4 de enero de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT01077739

Inglés

Eligibility Colorectal Cancer NCT01077739

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients >/=18 years of age
Descripción

Adult | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
metastatic colorectal cancer
Descripción

Colorectal cancer metastatic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948380
at least 1 measurable lesion according to recist v. 1.1
Descripción

Measurable lesion Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
patients with disease progression with prior folfiri + avastin therapy who are not candidates for primary metastasectomy
Descripción

Disease Progression | FOLFIRI Regimen | Avastin | Absence Schedule Metastasectomy Primary

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C1880658
UMLS CUI [3]
C1135130
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0030703
UMLS CUI [4,3]
C2363923
UMLS CUI [4,4]
C0205225
disease progression </= 8 weeks after last dose of avastin
Descripción

Disease Progression

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242656
ecog </=2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
no more than 8 weeks between 1st-line treatment with folfiri + avastin and 2nd-line treatment with xelox or folfox + avastin
Descripción

First line treatment | FOLFIRI Regimen | Avastin | Second line treatment | XELOX | FOLFOX Regimen

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1708063
UMLS CUI [2]
C1880658
UMLS CUI [3]
C1135130
UMLS CUI [4]
C1710038
UMLS CUI [5]
C1956962
UMLS CUI [6]
C0392943
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
disease progression > 8 weeks after last avastin administration
Descripción

Disease Progression | Status post Avastin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1135130
clinically significant cardiovascular disease
Descripción

Cardiovascular Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
cns disease except for treated brain metastasis
Descripción

CNS disorder | Exception Metastatic malignant neoplasm to brain Treated

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0220650
UMLS CUI [2,3]
C1522326
history of other malignancies within 2 years prior to start of study treatment (with the exception of curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix)
Descripción

Cancer Other | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Curative treatment Carcinoma in situ of uterine cervix

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0851140
major surgery, open biopsy, or significant traumatic injury within 28 days prior to start of study treatment
Descripción

Major surgery | Incisional biopsy | Traumatic injury

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0184922
UMLS CUI [3]
C3263723
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Similar models

Eligibility Colorectal Cancer NCT01077739

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients >/=18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Colorectal cancer metastatic
Item
metastatic colorectal cancer
boolean
C0948380 (UMLS CUI [1])
Measurable lesion Quantity
Item
at least 1 measurable lesion according to recist v. 1.1
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Disease Progression | FOLFIRI Regimen | Avastin | Absence Schedule Metastasectomy Primary
Item
patients with disease progression with prior folfiri + avastin therapy who are not candidates for primary metastasectomy
boolean
C0242656 (UMLS CUI [1])
C1880658 (UMLS CUI [2])
C1135130 (UMLS CUI [3])
C0332197 (UMLS CUI [4,1])
C0030703 (UMLS CUI [4,2])
C2363923 (UMLS CUI [4,3])
C0205225 (UMLS CUI [4,4])
Disease Progression
Item
disease progression </= 8 weeks after last dose of avastin
boolean
C0242656 (UMLS CUI [1])
ECOG performance status
Item
ecog </=2
boolean
C1520224 (UMLS CUI [1])
First line treatment | FOLFIRI Regimen | Avastin | Second line treatment | XELOX | FOLFOX Regimen
Item
no more than 8 weeks between 1st-line treatment with folfiri + avastin and 2nd-line treatment with xelox or folfox + avastin
boolean
C1708063 (UMLS CUI [1])
C1880658 (UMLS CUI [2])
C1135130 (UMLS CUI [3])
C1710038 (UMLS CUI [4])
C1956962 (UMLS CUI [5])
C0392943 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Disease Progression | Status post Avastin
Item
disease progression > 8 weeks after last avastin administration
boolean
C0242656 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1135130 (UMLS CUI [2,2])
Cardiovascular Disease
Item
clinically significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
CNS disorder | Exception Metastatic malignant neoplasm to brain Treated
Item
cns disease except for treated brain metastasis
boolean
C0007682 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
Cancer Other | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Curative treatment Carcinoma in situ of uterine cervix
Item
history of other malignancies within 2 years prior to start of study treatment (with the exception of curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0553723 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0851140 (UMLS CUI [4,3])
Major surgery | Incisional biopsy | Traumatic injury
Item
major surgery, open biopsy, or significant traumatic injury within 28 days prior to start of study treatment
boolean
C0679637 (UMLS CUI [1])
C0184922 (UMLS CUI [2])
C3263723 (UMLS CUI [3])
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