ID

15008

Description

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

Link

https://clinicaltrials.gov/show/NCT00506168

Keywords

Versions (1)
  1. 5/11/16 5/11/16 -
Uploaded on

May 11, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Neoplasms NCT00506168

English

Eligibility Colorectal Neoplasms NCT00506168

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed metastatic colorectal cancer
Description

Colorectal Cancer, metastasised

Data type

boolean

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

Ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
mesurable lesions
Description

Measurable Disease

Data type

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
Description

Chemotherapy or Radiotherapy

Data type

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
Description

Chemotherapy or radiotherapy

Data type

boolean

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

Organ function

Data type

boolean

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

Expected survival

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Prior systemic chemotherapy for metastatic disease
Description

Chemotherapy

Data type

boolean

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

Oxaliplatin or Irinotecan

Data type

boolean

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

Cns metastases

Data type

boolean

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

Cardiovascular disease

Data type

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
Description

Infection or nonmalignant illness

Data type

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
Description

Other malignancy

Data type

boolean

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

Psychiatric disorder or uncontrolled seizure

Data type

boolean

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

Pregnancy

Data type

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.
Description

Drugs interacting with capecitabine

Data type

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
Description

Severe reaction to fluoropyrimidine or dihydropyrimidine dehydrogenase deficiency

Data type

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
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
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Similar models

Eligibility Colorectal Neoplasms NCT00506168

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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