ID

30762

Description

Dose Adaptation of Capecitabine Using Mobile Phone Toxicity Monitoring; ODM derived from: https://clinicaltrials.gov/show/NCT01053104

Link

https://clinicaltrials.gov/show/NCT01053104

Keywords

Versions (1)
  1. 6/20/18 6/20/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 20, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer NCT01053104

English

Eligibility Metastatic Colorectal Cancer NCT01053104

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
metastatic colorectal or breast cancer patients commencing treatment on one of four specified regimens
Description

Colorectal cancer metastatic | Secondary malignant neoplasm of female breast | Start Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0948380
UMLS CUI [2]
C0346993
UMLS CUI [3,1]
C0439659
UMLS CUI [3,2]
C0087111
for metastatic colorectal cancer:
Description

Colorectal cancer metastatic

Data type

boolean

Alias
UMLS CUI [1]
C0948380
capecitabine 2000mg/m2 d 1-14, q 3 weekly and oxaliplatin 130mg/m2 d1 q 3 weekly (capox)
Description

Capecitabine Dosage | Oxaliplatin Dosage | CAPOX Regimen

Data type

boolean

Alias
UMLS CUI [1,1]
C0671970
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C0069717
UMLS CUI [2,2]
C0178602
UMLS CUI [3]
C1879915
capecitabine 2500mg/m2 d 1-14, q 3 weekly
Description

Capecitabine Dosage

Data type

boolean

Alias
UMLS CUI [1,1]
C0671970
UMLS CUI [1,2]
C0178602
for metastatic breast cancer:
Description

Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C0346993
capecitabine 2000mg/m2d 1-14, q 3 weekly
Description

Capecitabine Dosage

Data type

boolean

Alias
UMLS CUI [1,1]
C0671970
UMLS CUI [1,2]
C0178602
capecitabine 2000mg/m2 d 1-14, q 3 weekly and docetaxel 75mg/m2 d1 q 3 weekly
Description

Capecitabine Dosage | Docetaxel Dosage

Data type

boolean

Alias
UMLS CUI [1,1]
C0671970
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C0246415
UMLS CUI [2,2]
C0178602
age > 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
fit to start at full (100%) starting dose of all drugs
Description

Fit Pharmaceutical Preparations Dose Full

Data type

boolean

Alias
UMLS CUI [1,1]
C0424576
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0443225
able and willing to use mobile phone
Description

Able to operate mobile phone | Use of Mobile Phone Willing

Data type

boolean

Alias
UMLS CUI [1]
C4274610
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C1136360
UMLS CUI [2,3]
C0600109
reasonable renal, liver and bone marrow function
Description

Renal function | Liver function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0031843
absolute neutrophil count (anc) >1.5 x 109/l
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelet count > 100 x 109/l
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
total bilirubin <1.5 uln
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
alt, ast < 2.5 x uln
Description

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
alkaline phosphatase < 2.5 x uln
Description

Alkaline phosphatase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201850
no obvious contra indications to capecitabine or oxaliplatin or docetaxel
Description

Absence Medical contraindication Capecitabine | Absence Medical contraindication Oxaliplatin | Absence Medical contraindication Docetaxel

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C0671970
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C1301624
UMLS CUI [2,3]
C0069717
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C1301624
UMLS CUI [3,3]
C0246415
patients must also be able to read, write and understand english.
Description

Able to read English Language | Able to write English Language | Comprehension English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0233733
UMLS CUI [3,2]
C0376245
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who live in an area of no vodafone or orange mobile phone network - -
Description

Residence | Mobile Phone Network Lacking | Other Coding

Data type

boolean

Alias
UMLS CUI [1]
C0237096
UMLS CUI [2,1]
C1136360
UMLS CUI [2,2]
C1882071
UMLS CUI [2,3]
C0332268
UMLS CUI [3]
C3846158
patients participating in other cancer treatment trials
Description

Study Subject Participation Status | Cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0920425
moderate or severe renal impairment [creatinine clearance <30ml/min (calculated according to cockroft-gault formula)]
Description

Renal Insufficiency Moderate | Renal Insufficiency Severe | Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C2711451
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Similar models

Eligibility Metastatic Colorectal Cancer NCT01053104

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal cancer metastatic | Secondary malignant neoplasm of female breast | Start Therapeutic procedure
Item
metastatic colorectal or breast cancer patients commencing treatment on one of four specified regimens
boolean
C0948380 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
C0439659 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
Colorectal cancer metastatic
Item
for metastatic colorectal cancer:
boolean
C0948380 (UMLS CUI [1])
Capecitabine Dosage | Oxaliplatin Dosage | CAPOX Regimen
Item
capecitabine 2000mg/m2 d 1-14, q 3 weekly and oxaliplatin 130mg/m2 d1 q 3 weekly (capox)
boolean
C0671970 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0069717 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1879915 (UMLS CUI [3])
Capecitabine Dosage
Item
capecitabine 2500mg/m2 d 1-14, q 3 weekly
boolean
C0671970 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Secondary malignant neoplasm of female breast
Item
for metastatic breast cancer:
boolean
C0346993 (UMLS CUI [1])
Capecitabine Dosage
Item
capecitabine 2000mg/m2d 1-14, q 3 weekly
boolean
C0671970 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Capecitabine Dosage | Docetaxel Dosage
Item
capecitabine 2000mg/m2 d 1-14, q 3 weekly and docetaxel 75mg/m2 d1 q 3 weekly
boolean
C0671970 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0246415 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
Fit Pharmaceutical Preparations Dose Full
Item
fit to start at full (100%) starting dose of all drugs
boolean
C0424576 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0443225 (UMLS CUI [1,4])
Able to operate mobile phone | Use of Mobile Phone Willing
Item
able and willing to use mobile phone
boolean
C4274610 (UMLS CUI [1])
C1524063 (UMLS CUI [2,1])
C1136360 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Renal function | Liver function | Bone Marrow function
Item
reasonable renal, liver and bone marrow function
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
Absolute neutrophil count
Item
absolute neutrophil count (anc) >1.5 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count > 100 x 109/l
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin <1.5 uln
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
alt, ast < 2.5 x uln
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Alkaline phosphatase measurement
Item
alkaline phosphatase < 2.5 x uln
boolean
C0201850 (UMLS CUI [1])
Absence Medical contraindication Capecitabine | Absence Medical contraindication Oxaliplatin | Absence Medical contraindication Docetaxel
Item
no obvious contra indications to capecitabine or oxaliplatin or docetaxel
boolean
C0332197 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C0671970 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])
C0069717 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C1301624 (UMLS CUI [3,2])
C0246415 (UMLS CUI [3,3])
Able to read English Language | Able to write English Language | Comprehension English Language
Item
patients must also be able to read, write and understand english.
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0233733 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Residence | Mobile Phone Network Lacking | Other Coding
Item
patients who live in an area of no vodafone or orange mobile phone network - -
boolean
C0237096 (UMLS CUI [1])
C1136360 (UMLS CUI [2,1])
C1882071 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
C3846158 (UMLS CUI [3])
Study Subject Participation Status | Cancer treatment
Item
patients participating in other cancer treatment trials
boolean
C2348568 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
Renal Insufficiency Moderate | Renal Insufficiency Severe | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
moderate or severe renal impairment [creatinine clearance <30ml/min (calculated according to cockroft-gault formula)]
boolean
C1565489 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2711451 (UMLS CUI [3])
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