ID

15008

Beschrijving

Study of Irinotecan & Capecitabine in Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00506168

Link

https://clinicaltrials.gov/show/NCT00506168

Trefwoorden

Versies (1)
  1. 11-05-16 11-05-16 -
Geüploaded op

11 mei 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Colorectal Neoplasms NCT00506168

Engels

Eligibility Colorectal Neoplasms NCT00506168

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed metastatic colorectal cancer
Beschrijving

Colorectal Cancer, metastasised

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C0027627
Ecog performance status 0-2
Beschrijving

Ecog

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
mesurable lesions
Beschrijving

Measurable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
No prior chemotherapy or radiotherapy for metastatic disease. prior radiotherapy is permitted if it was not administered to target lesions selected for this study and provided it has been completed at least 4 weeks before registration
Beschrijving

Chemotherapy or Radiotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
Adjuvnat chemo or radiotherapy was completed at least 6 months prior to start study treatment
Beschrijving

Chemotherapy or radiotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
Adequate organ functions
Beschrijving

Organ function

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
Expected survival is longer then 6 months
Beschrijving

Expected survival

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
Informed consent
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
Prior systemic chemotherapy for metastatic disease
Beschrijving

Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
Prior treatment with oxaliplatin or irinotecan
Beschrijving

Oxaliplatin or Irinotecan

Datatype

boolean

Alias
UMLS CUI [1]
C0069717
UMLS CUI [2]
C0123931
Cns metastases
Beschrijving

Cns metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0686377
Uncontrolled or severe cardiovascular disease
Beschrijving

Cardiovascular disease

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
Beschrijving

Infection or nonmalignant illness

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1518371
Other malignancy within the past 3 years except cured non-melanomatous skin cancer or carcinoma in situ of the cervix
Beschrijving

Other malignancy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
Psychiatric disorder or uncontrolled seizure that would preclude compliance
Beschrijving

Psychiatric disorder or uncontrolled seizure

Datatype

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0036572
pregnant, nursing women or patients with reproductive potential without contraception
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
Patients receiving a concomitant treatment with drugs interacting with capecitabine such as flucytosine, phenytoin, or warfarin et al.
Beschrijving

Drugs interacting with capecitabine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0687133
UMLS CUI [1,2]
C0671970
prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (dpd) deficiency
Beschrijving

Severe reaction to fluoropyrimidine or dihydropyrimidine dehydrogenase deficiency

Datatype

boolean

Alias
UMLS CUI [1,1]
C0596581
UMLS CUI [1,2]
C1527304
UMLS CUI [2]
C1959620
Major surgery within 3 weeks prior to study treatment starts, or lack of complete recovery from the effects of major surgery
Beschrijving

Major surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0679637
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Similar models

Eligibility Colorectal Neoplasms NCT00506168

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Cancer, metastasised
Item
histologically confirmed metastatic colorectal cancer
boolean
C0009402 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Ecog
Item
Ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Measurable Disease
Item
mesurable lesions
boolean
C1513041 (UMLS CUI [1])
Chemotherapy or Radiotherapy
Item
No prior chemotherapy or radiotherapy for metastatic disease. prior radiotherapy is permitted if it was not administered to target lesions selected for this study and provided it has been completed at least 4 weeks before registration
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Chemotherapy or radiotherapy
Item
Adjuvnat chemo or radiotherapy was completed at least 6 months prior to start study treatment
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Organ function
Item
Adequate organ functions
boolean
C0678852 (UMLS CUI [1])
Expected survival
Item
Expected survival is longer then 6 months
boolean
C0023671 (UMLS CUI [1])
Informed consent
Item
Informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy
Item
Prior systemic chemotherapy for metastatic disease
boolean
C0392920 (UMLS CUI [1])
Oxaliplatin or Irinotecan
Item
Prior treatment with oxaliplatin or irinotecan
boolean
C0069717 (UMLS CUI [1])
C0123931 (UMLS CUI [2])
Cns metastases
Item
Cns metastases
boolean
C0686377 (UMLS CUI [1])
Cardiovascular disease
Item
Uncontrolled or severe cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Infection or nonmalignant illness
Item
Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
boolean
C0009450 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C1518371 (UMLS CUI [2,2])
Other malignancy
Item
Other malignancy within the past 3 years except cured non-melanomatous skin cancer or carcinoma in situ of the cervix
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Psychiatric disorder or uncontrolled seizure
Item
Psychiatric disorder or uncontrolled seizure that would preclude compliance
boolean
C0004936 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
Pregnancy
Item
pregnant, nursing women or patients with reproductive potential without contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Drugs interacting with capecitabine
Item
Patients receiving a concomitant treatment with drugs interacting with capecitabine such as flucytosine, phenytoin, or warfarin et al.
boolean
C0687133 (UMLS CUI [1,1])
C0671970 (UMLS CUI [1,2])
Severe reaction to fluoropyrimidine or dihydropyrimidine dehydrogenase deficiency
Item
prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (dpd) deficiency
boolean
C0596581 (UMLS CUI [1,1])
C1527304 (UMLS CUI [1,2])
C1959620 (UMLS CUI [2])
Major surgery
Item
Major surgery within 3 weeks prior to study treatment starts, or lack of complete recovery from the effects of major surgery
boolean
C0679637 (UMLS CUI [1])
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