ID

16501

Descripción

XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00212615

Link

https://clinicaltrials.gov/show/NCT00212615

Palabras clave

Versiones (1)
  1. 20/7/16 20/7/16 -
Subido en

20 de julio de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility C04.588.274.476.411.307 NCT00212615

Inglés

Eligibility C04.588.274.476.411.307 NCT00212615

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological proven adenocarcinoma of the colon or rectum
Descripción

Adenocarcinoma of colon | Adenocarcinoma of rectum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0338106
UMLS CUI [2]
C0149978
measurable or non-measurable disease
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
performance status 0-2
Descripción

performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1518965
adequate renal and hepatic functions
Descripción

Renal function | Liver function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
adjuvant chemotherapy must have ended 180 days before inclusion
Descripción

Adjuvant Chemotherapy Ended

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C1272693
written informed consent prior to randomization
Descripción

Informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with eloxatin or xeloda
Descripción

Eloxatin | Xeloda

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1135117
UMLS CUI [2]
C0724419
peripheral neuropathy
Descripción

Peripheral Neuropathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0031117
evidence of cns metastasis
Descripción

CNS metastases Evidence of

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0332120
other serious illness or medical conditions (including contraindication to 5 fu e.g.: angor, myocardial infarction within 6 months)
Descripción

Illness Serious | Other medical condition | Medical contraindication Fluorouracil | Angina Pectoris | Myocardial Infarction

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C3843040
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0016360
UMLS CUI [4]
C0002962
UMLS CUI [5]
C0027051
past history of malignant neoplasm within the past five years, except curatively treated non melanoma skin cancer
Descripción

Malignant Neoplasms | Skin carcinoma curative treatment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0699893
UMLS CUI [2,2]
C1273390
administration of any other experimental drug under investigation within 2 weeks before randomisation
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
pregnant or breast feeding women
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
fertile patients must use adequate contraceptives
Descripción

Fertility Contraceptives

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0009871
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Similar models

Eligibility C04.588.274.476.411.307 NCT00212615

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of colon | Adenocarcinoma of rectum
Item
histological proven adenocarcinoma of the colon or rectum
boolean
C0338106 (UMLS CUI [1])
C0149978 (UMLS CUI [2])
Measurable Disease
Item
measurable or non-measurable disease
boolean
C1513041 (UMLS CUI [1])
performance status
Item
performance status 0-2
boolean
C1518965 (UMLS CUI [1])
Renal function | Liver function
Item
adequate renal and hepatic functions
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
Adjuvant Chemotherapy Ended
Item
adjuvant chemotherapy must have ended 180 days before inclusion
boolean
C0085533 (UMLS CUI [1,1])
C1272693 (UMLS CUI [1,2])
Informed consent
Item
written informed consent prior to randomization
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Eloxatin | Xeloda
Item
prior treatment with eloxatin or xeloda
boolean
C1135117 (UMLS CUI [1])
C0724419 (UMLS CUI [2])
Peripheral Neuropathy
Item
peripheral neuropathy
boolean
C0031117 (UMLS CUI [1])
CNS metastases Evidence of
Item
evidence of cns metastasis
boolean
C0686377 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Illness Serious | Other medical condition | Medical contraindication Fluorouracil | Angina Pectoris | Myocardial Infarction
Item
other serious illness or medical conditions (including contraindication to 5 fu e.g.: angor, myocardial infarction within 6 months)
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0016360 (UMLS CUI [3,2])
C0002962 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
Malignant Neoplasms | Skin carcinoma curative treatment
Item
past history of malignant neoplasm within the past five years, except curatively treated non melanoma skin cancer
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
Investigational New Drugs
Item
administration of any other experimental drug under investigation within 2 weeks before randomisation
boolean
C0013230 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Fertility Contraceptives
Item
fertile patients must use adequate contraceptives
boolean
C0015895 (UMLS CUI [1,1])
C0009871 (UMLS CUI [1,2])
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