ID

16767

Description

Capecitabine and Gemcitabine in Patients With Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00159445

Link

https://clinicaltrials.gov/show/NCT00159445

Keywords

Versions (1)
  1. 8/5/16 8/5/16 -
Uploaded on

August 5, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00159445

English

Eligibility Colorectal Cancer NCT00159445

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed metastatic adenocarcinoma of the colon or rectum, with measurable disease. the primary histologic diagnosis is sufficient if there is clear evidence by imaging and/or markers of metastatic disease sites.
Description

COLON ADENOCARCINOMA METASTATIC | Adenocarcinoma of rectum metastatic | Measurable Disease | Neoplasm Metastasis Site Evidence of | Imaging | Markers

Data type

boolean

Alias
UMLS CUI [1]
C0742581
UMLS CUI [2,1]
C0149978
UMLS CUI [2,2]
C1522484
UMLS CUI [3]
C1513041
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C1515974
UMLS CUI [4,3]
C0332120
UMLS CUI [5]
C0011923
UMLS CUI [6]
C2745888
patients must have failed cpt-11 and oxaliplatin based therapies.
Description

Therapeutic procedure Irinotecan hydrochloride Based failed | Therapeutic procedure oxaliplatin Based failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0594375
UMLS CUI [1,3]
C1705938
UMLS CUI [1,4]
C0231175
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0069717
UMLS CUI [2,3]
C1705938
UMLS CUI [2,4]
C0231175
patients must have received at least two prior chemotherapy regimens for advanced disease (completed > 4 weeks prior to enrollment).
Description

Prior Chemotherapy Quantity advanced disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0679246
tumor must be accessible for biopsy or paraffin embedded tissue must be available for review.
Description

Malignant Neoplasm Amenable Biopsy | Paraffin Embedded Tissue Available

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0005558
UMLS CUI [2,1]
C1519524
UMLS CUI [2,2]
C0470187
swog performance status 0-2.
Description

SWOG performance status

Data type

boolean

Alias
UMLS CUI [1,1]
C1519429
UMLS CUI [1,2]
C1518965
agc >1000, platelets >100,000.
Description

Absolute neutrophil count | Blood Platelets

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0005821
total bilirubin < 3 x upper limit of normal. transaminase (ast and/or alt) < 2 x upper limit of normal or < 5 x upper limit of normal in patients with liver metastasis.
Description

Bilirubin, total measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver

Data type

boolean

Alias
UMLS CUI [1]
C0201913
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0494165
patients must have a measured or calculated creatinine clearance greater than 35 ml/min obtained within 28 days prior to registration.
Description

Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2]
C2711451
age greater than or equal to 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients should have hemoglobin > 9 g/dl; patients may be transfused to achieve this level of hemoglobin.
Description

Hemoglobin | Blood Transfusion

Data type

boolean

Alias
UMLS CUI [1]
C0019046
UMLS CUI [2]
C0005841
except for cancer-related abnormalities, patients should not have unstable or pre-existing major medical conditions.
Description

Abnormality Related to Cancer | medical condition Major Pre-existing | medical condition Major Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2826292
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205164
UMLS CUI [2,3]
C2347662
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0205164
UMLS CUI [3,3]
C0443343
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of a malignancy other than colon or rectal cancer, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years.
Description

Malignant Neoplasms | Colon Carcinoma | Rectal Carcinoma | Basal cell carcinoma Treated Adequate | Squamous cell carcinoma of skin | Carcinoma in situ of uterine cervix | Malignant Neoplasm Free of

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699790
UMLS CUI [3]
C0007113
UMLS CUI [4,1]
C0007117
UMLS CUI [4,2]
C1522326
UMLS CUI [4,3]
C0205411
UMLS CUI [5]
C0553723
UMLS CUI [6]
C0851140
UMLS CUI [7,1]
C0006826
UMLS CUI [7,2]
C0332296
patients with brain metastasis.
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
history of recent (within one year) myocardial infarction or evidence of congestive heart failure.
Description

Myocardial Infarction | Congestive heart failure Evidence of

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C0332120
patients that have psychological, familial, sociological, or geographical conditions that do not permit medical follow-up and compliance with the study protocol.
Description

Condition Preventing Follow-up | Condition Preventing Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C3274571
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0525058
patients should not have any immediate life-threatening complications of their malignancies.
Description

Malignant Neoplasms Complication Life Threatening Immediate

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0009566
UMLS CUI [1,3]
C2826244
UMLS CUI [1,4]
C0205253
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Similar models

Eligibility Colorectal Cancer NCT00159445

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
COLON ADENOCARCINOMA METASTATIC | Adenocarcinoma of rectum metastatic | Measurable Disease | Neoplasm Metastasis Site Evidence of | Imaging | Markers
Item
histologically confirmed metastatic adenocarcinoma of the colon or rectum, with measurable disease. the primary histologic diagnosis is sufficient if there is clear evidence by imaging and/or markers of metastatic disease sites.
boolean
C0742581 (UMLS CUI [1])
C0149978 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3])
C0027627 (UMLS CUI [4,1])
C1515974 (UMLS CUI [4,2])
C0332120 (UMLS CUI [4,3])
C0011923 (UMLS CUI [5])
C2745888 (UMLS CUI [6])
Therapeutic procedure Irinotecan hydrochloride Based failed | Therapeutic procedure oxaliplatin Based failed
Item
patients must have failed cpt-11 and oxaliplatin based therapies.
boolean
C0087111 (UMLS CUI [1,1])
C0594375 (UMLS CUI [1,2])
C1705938 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
C0087111 (UMLS CUI [2,1])
C0069717 (UMLS CUI [2,2])
C1705938 (UMLS CUI [2,3])
C0231175 (UMLS CUI [2,4])
Prior Chemotherapy Quantity advanced disease
Item
patients must have received at least two prior chemotherapy regimens for advanced disease (completed > 4 weeks prior to enrollment).
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0679246 (UMLS CUI [1,3])
Malignant Neoplasm Amenable Biopsy | Paraffin Embedded Tissue Available
Item
tumor must be accessible for biopsy or paraffin embedded tissue must be available for review.
boolean
C0006826 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
C1519524 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
SWOG performance status
Item
swog performance status 0-2.
boolean
C1519429 (UMLS CUI [1,1])
C1518965 (UMLS CUI [1,2])
Absolute neutrophil count | Blood Platelets
Item
agc >1000, platelets >100,000.
boolean
C0948762 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
Bilirubin, total measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver
Item
total bilirubin < 3 x upper limit of normal. transaminase (ast and/or alt) < 2 x upper limit of normal or < 5 x upper limit of normal in patients with liver metastasis.
boolean
C0201913 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0494165 (UMLS CUI [4])
Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
patients must have a measured or calculated creatinine clearance greater than 35 ml/min obtained within 28 days prior to registration.
boolean
C0373595 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Age
Item
age greater than or equal to 18 years
boolean
C0001779 (UMLS CUI [1])
Hemoglobin | Blood Transfusion
Item
patients should have hemoglobin > 9 g/dl; patients may be transfused to achieve this level of hemoglobin.
boolean
C0019046 (UMLS CUI [1])
C0005841 (UMLS CUI [2])
Abnormality Related to Cancer | medical condition Major Pre-existing | medical condition Major Unstable
Item
except for cancer-related abnormalities, patients should not have unstable or pre-existing major medical conditions.
boolean
C1704258 (UMLS CUI [1,1])
C2826292 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C2347662 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C0443343 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Colon Carcinoma | Rectal Carcinoma | Basal cell carcinoma Treated Adequate | Squamous cell carcinoma of skin | Carcinoma in situ of uterine cervix | Malignant Neoplasm Free of
Item
history of a malignancy other than colon or rectal cancer, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years.
boolean
C0006826 (UMLS CUI [1])
C0699790 (UMLS CUI [2])
C0007113 (UMLS CUI [3])
C0007117 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0205411 (UMLS CUI [4,3])
C0553723 (UMLS CUI [5])
C0851140 (UMLS CUI [6])
C0006826 (UMLS CUI [7,1])
C0332296 (UMLS CUI [7,2])
Metastatic malignant neoplasm to brain
Item
patients with brain metastasis.
boolean
C0220650 (UMLS CUI [1])
Myocardial Infarction | Congestive heart failure Evidence of
Item
history of recent (within one year) myocardial infarction or evidence of congestive heart failure.
boolean
C0027051 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
Condition Preventing Follow-up | Condition Preventing Protocol Compliance
Item
patients that have psychological, familial, sociological, or geographical conditions that do not permit medical follow-up and compliance with the study protocol.
boolean
C0348080 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Malignant Neoplasms Complication Life Threatening Immediate
Item
patients should not have any immediate life-threatening complications of their malignancies.
boolean
C0006826 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C2826244 (UMLS CUI [1,3])
C0205253 (UMLS CUI [1,4])
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