ID

18124

Beschrijving

A Study of the Combination of Pemetrexed and Irinotecan Every Two Weeks in Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00191984

Link

https://clinicaltrials.gov/show/NCT00191984

Trefwoorden

Versies (1)
  1. 21-10-16 21-10-16 -
Geüploaded op

21 oktober 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer NCT00191984

Engels

Eligibility Metastatic Colorectal Cancer NCT00191984

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of metastatic colorectal adenocarcinoma that is not amenable to curative therapy.
Beschrijving

Adenocarcinoma of large intestine Metastatic Amenable curative treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319315
UMLS CUI [1,2]
C0036525
UMLS CUI [1,3]
C3900053
UMLS CUI [1,4]
C1273390
patient must have at least one unidimensionally measurable lesion.
Beschrijving

Measurable Disease Linear

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
prior radiation therapy to less than 25% of bone marrow. radiation must be completed at least 4 weeks prior to study enrollment.
Beschrijving

prior radiation therapy Bone Marrow | Therapeutic radiology procedure Completed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0005953
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205197
performance status 0 to 2
Beschrijving

performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1518965
patient must have received 1 prior course of chemotherapy (folfox regimen) for metastatic disease
Beschrijving

Prior Chemotherapy Metastatic Neoplasm | FOLFOX Regimen Metastatic Neoplasm

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C2939420
UMLS CUI [2,1]
C0392943
UMLS CUI [2,2]
C2939420
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with any drug within the last 30 days that has not received regulatory approval.
Beschrijving

Drugs, Non-Prescription

Datatype

boolean

Alias
UMLS CUI [1]
C0013231
serious systemic disorder (cardiac or pulmonary disease, active infection)
Beschrijving

Systemic disease Serious | Heart Disease | Lung disease | Communicable Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0009450
documented brain metastases not amenable to surgery or unstable after radiation
Beschrijving

Metastatic malignant neoplasm to brain Amenable Operative Surgical Procedures | Metastatic malignant neoplasm to brain Unstable status Post Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0543467
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C0687676
UMLS CUI [2,4]
C1522449
inability or unwillingness to take folic acid or vitamin b12 supplementation.
Beschrijving

Folic acid supplementation Unwilling | Vitamin B12 supplement Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0556110
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C3661610
UMLS CUI [2,2]
C0558080
presence of fluid retention that can not be controlled by drainage.
Beschrijving

fluid retention | Drainage Unsuccessful

Datatype

boolean

Alias
UMLS CUI [1]
C0268000
UMLS CUI [2,1]
C0013103
UMLS CUI [2,2]
C1272705
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Similar models

Eligibility Metastatic Colorectal Cancer NCT00191984

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of large intestine Metastatic Amenable curative treatment
Item
diagnosis of metastatic colorectal adenocarcinoma that is not amenable to curative therapy.
boolean
C1319315 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
C3900053 (UMLS CUI [1,3])
C1273390 (UMLS CUI [1,4])
Measurable Disease Linear
Item
patient must have at least one unidimensionally measurable lesion.
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
prior radiation therapy Bone Marrow | Therapeutic radiology procedure Completed
Item
prior radiation therapy to less than 25% of bone marrow. radiation must be completed at least 4 weeks prior to study enrollment.
boolean
C0279134 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
performance status
Item
performance status 0 to 2
boolean
C1518965 (UMLS CUI [1])
Prior Chemotherapy Metastatic Neoplasm | FOLFOX Regimen Metastatic Neoplasm
Item
patient must have received 1 prior course of chemotherapy (folfox regimen) for metastatic disease
boolean
C1514457 (UMLS CUI [1,1])
C2939420 (UMLS CUI [1,2])
C0392943 (UMLS CUI [2,1])
C2939420 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Drugs, Non-Prescription
Item
treatment with any drug within the last 30 days that has not received regulatory approval.
boolean
C0013231 (UMLS CUI [1])
Systemic disease Serious | Heart Disease | Lung disease | Communicable Disease
Item
serious systemic disorder (cardiac or pulmonary disease, active infection)
boolean
C0442893 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0009450 (UMLS CUI [4])
Metastatic malignant neoplasm to brain Amenable Operative Surgical Procedures | Metastatic malignant neoplasm to brain Unstable status Post Therapeutic radiology procedure
Item
documented brain metastases not amenable to surgery or unstable after radiation
boolean
C0220650 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0220650 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C1522449 (UMLS CUI [2,4])
Folic acid supplementation Unwilling | Vitamin B12 supplement Unwilling
Item
inability or unwillingness to take folic acid or vitamin b12 supplementation.
boolean
C0556110 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C3661610 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
fluid retention | Drainage Unsuccessful
Item
presence of fluid retention that can not be controlled by drainage.
boolean
C0268000 (UMLS CUI [1])
C0013103 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
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