ID

28284

Beschrijving

Study of S-1 Plus LV for Untreated Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00891332

Link

https://clinicaltrials.gov/show/NCT00891332

Trefwoorden

Versies (1)
  1. 02-01-18 02-01-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

2 januari 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00891332

Engels

Eligibility Colorectal Cancer NCT00891332

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proved adenocarcinoma
Beschrijving

Adenocarcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0001418
unresectable and recurrent colorectal cancer
Beschrijving

Colorectal cancer recurrent unresectable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0854750
UMLS CUI [1,2]
C1519810
age20 ≤ at enrollment
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
performance status 0 or 1 (ecog)
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
no prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received s-1 containing treatment shall be excluded
Beschrijving

Absence Prior Therapy Advanced disease | Absence Prior radiation therapy Advanced disease | Absence Prior Chemotherapy Advanced disease | Absence Prior Hormone Therapy Advanced disease | Chemotherapy, Adjuvant | Exclusion Therapeutic procedure Containing S-1

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0679246
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0279134
UMLS CUI [2,3]
C0679246
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C1514457
UMLS CUI [3,3]
C0679246
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C1514460
UMLS CUI [4,3]
C0679246
UMLS CUI [5]
C0085533
UMLS CUI [6,1]
C2828389
UMLS CUI [6,2]
C0087111
UMLS CUI [6,3]
C0332256
UMLS CUI [6,4]
C0879262
adequate hematologic, hepatic and renal functions
Beschrijving

Hematologic function | Liver function | Renal function

Datatype

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
at least one measurable lesion by recist criteria
Beschrijving

Measurable lesion Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
serious drug hypersensitivity
Beschrijving

Drug Allergy Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C0205404
pregnant or nursing
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
bleeding from gastrointestinal tract
Beschrijving

Gastrointestinal Hemorrhage

Datatype

boolean

Alias
UMLS CUI [1]
C0017181
diarrhea
Beschrijving

Diarrhea

Datatype

boolean

Alias
UMLS CUI [1]
C0011991
simultaneously active double cancer
Beschrijving

Malignant Neoplasm Double

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205173
serious illness or medical condition
Beschrijving

Illness Serious | Medical condition Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
brain metastasis
Beschrijving

Metastatic malignant neoplasm to brain

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
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Similar models

Eligibility Colorectal Cancer NCT00891332

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma
Item
histologically proved adenocarcinoma
boolean
C0001418 (UMLS CUI [1])
Colorectal cancer recurrent unresectable
Item
unresectable and recurrent colorectal cancer
boolean
C0854750 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
Age
Item
age20 ≤ at enrollment
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
performance status 0 or 1 (ecog)
boolean
C1520224 (UMLS CUI [1])
Absence Prior Therapy Advanced disease | Absence Prior radiation therapy Advanced disease | Absence Prior Chemotherapy Advanced disease | Absence Prior Hormone Therapy Advanced disease | Chemotherapy, Adjuvant | Exclusion Therapeutic procedure Containing S-1
Item
no prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received s-1 containing treatment shall be excluded
boolean
C0332197 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0679246 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0279134 (UMLS CUI [2,2])
C0679246 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C1514457 (UMLS CUI [3,2])
C0679246 (UMLS CUI [3,3])
C0332197 (UMLS CUI [4,1])
C1514460 (UMLS CUI [4,2])
C0679246 (UMLS CUI [4,3])
C0085533 (UMLS CUI [5])
C2828389 (UMLS CUI [6,1])
C0087111 (UMLS CUI [6,2])
C0332256 (UMLS CUI [6,3])
C0879262 (UMLS CUI [6,4])
Hematologic function | Liver function | Renal function
Item
adequate hematologic, hepatic and renal functions
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Measurable lesion Quantity
Item
at least one measurable lesion by recist criteria
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Drug Allergy Serious
Item
serious drug hypersensitivity
boolean
C0013182 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gastrointestinal Hemorrhage
Item
bleeding from gastrointestinal tract
boolean
C0017181 (UMLS CUI [1])
Diarrhea
Item
diarrhea
boolean
C0011991 (UMLS CUI [1])
Malignant Neoplasm Double
Item
simultaneously active double cancer
boolean
C0006826 (UMLS CUI [1,1])
C0205173 (UMLS CUI [1,2])
Illness Serious | Medical condition Serious
Item
serious illness or medical condition
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Metastatic malignant neoplasm to brain
Item
brain metastasis
boolean
C0220650 (UMLS CUI [1])
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