ID

20214

Beskrivning

Combination of Cetuximab, Capecitabine, and Oxaliplatin With or Without Bevacizumab; ODM derived from: https://clinicaltrials.gov/show/NCT00321100

Länk

https://clinicaltrials.gov/show/NCT00321100

Nyckelord

Versioner (1)
  1. 2017-02-14 2017-02-14 -
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14 februari 2017

DOI

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Creative Commons BY 4.0
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Eligibility Colorectal Neoplasms NCT00321100

Engelsk

Eligibility Colorectal Neoplasms NCT00321100

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
measurable metastatic adenocarcinoma of the colon or rectum
Beskrivning

Adenocarcinoma of colon metastatic Measurable | Adenocarcinoma of rectum metastatic Measurable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0338106
UMLS CUI [1,2]
C1522484
UMLS CUI [1,3]
C1513040
UMLS CUI [2,1]
C0149978
UMLS CUI [2,2]
C1522484
UMLS CUI [2,3]
C1513040
no prior systemic therapy for metastatic disease
Beskrivning

systemic therapy Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0027627
adjuvant therapy must have been completed >/=12 months prior to recurrence, prior radiotherapy permitted but must have been completed > 6 months prior to study entry
Beskrivning

Adjuvant therapy Completed | Recurrence | Therapeutic radiology procedure Completed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677850
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C0034897
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0205197
must have tumor tissue available for egfr and thymidine phosphorylase evaluation
Beskrivning

Tumor tissue Available Epidermal Growth Factor Receptor Evaluation | Tumor tissue Available Thymidine Phosphorylase Evaluation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0034802
UMLS CUI [1,4]
C1261322
UMLS CUI [2,1]
C0475358
UMLS CUI [2,2]
C0470187
UMLS CUI [2,3]
C0040083
UMLS CUI [2,4]
C1261322
ecog ps 0-1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
age >/= 18
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
adequate organ function: wbc>/=3,000, anc >/=1,500, platelets>/= 100,000, total bilirubin </= 1.5x uln, ast&alt </= 2.5x uln, create clearance >/= 50ml/min
Beskrivning

Organ function | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201836
UMLS CUI [8]
C0373595
negative pregnancy test w/in 72 hours of treatment for women of child bearing potential
Beskrivning

Childbearing Potential Pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
ability to understand and willing to sign written icf
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
able to swallow and absorb oral medication
Beskrivning

Able to swallow oral medication | Oral medication Absorption Ability

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
UMLS CUI [2,1]
C0175795
UMLS CUI [2,2]
C0237442
UMLS CUI [2,3]
C0085732
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
medical or psychiatric condition which would potentially pose risk to patient by participation (i.e. but not limited to:uncontrolled hypertension, mi w/in 6 months,cns disease, pregnancy or nursing)
Beskrivning

Medical condition Study Subject Participation Status At risk | Mental condition Study Subject Participation Status At risk | Uncontrolled hypertension | Myocardial Infarction | CNS disorder | Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
UMLS CUI [3]
C1868885
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0007682
UMLS CUI [6]
C0032961
UMLS CUI [7]
C0006147
history of neoplasm (other than non-metastatic skin cancer or carcinoma in situ of cervix) w/in 5 years
Beskrivning

Neoplasms | Skin carcinoma nonmetastatic | Carcinoma in situ of uterine cervix

Datatyp

boolean

Alias
UMLS CUI [1]
C0027651
UMLS CUI [2,1]
C0699893
UMLS CUI [2,2]
C1518409
UMLS CUI [3]
C0851140
surgical procedure (not including closed biopsy or access port placement), open biopsy, significant traumatic injury w/in 28 days of registration or anticipation of need for surgical procedure while on study, fine needle aspiration or core biopsy w/in 7 days of registration
Beskrivning

Operative Surgical Procedures | Biopsy Closed | Injection/Infusion Ports Implantation | Incisional biopsy | Traumatic injury | Operative Surgical Procedures Patient need for | Fine needle aspiration biopsy | Core needle biopsy

Datatyp

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C0677512
UMLS CUI [3,1]
C0042371
UMLS CUI [3,2]
C0021107
UMLS CUI [4]
C0184922
UMLS CUI [5]
C3263723
UMLS CUI [6,1]
C0543467
UMLS CUI [6,2]
C0686904
UMLS CUI [7]
C1510483
UMLS CUI [8]
C1318309
urine protein:creatinine ration >/=1.0 at screening
Beskrivning

Urine protein/creatinine ratio measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1096054
evidence of bleeding diathesis or coagulopathy (in absence of anticoagulation)
Beskrivning

Bleeding tendency Evidence of | Blood Coagulation Disorders | Anticoagulation Therapy Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1458140
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C0005779
UMLS CUI [3,1]
C0003281
UMLS CUI [3,2]
C0332197
prior severe infusion reaction to mab or allergic reaction to capecitabine or oxaliplatin
Beskrivning

Infusion related reaction Severe Monoclonal Antibodies | Allergic Reaction capecitabine | Allergic Reaction oxaliplatin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0948715
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0003250
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0671970
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0069717
underlying neuropathy >/= grade 2
Beskrivning

Neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
tia or cva w/in 6 months
Beskrivning

Transient Ischemic Attack | Cerebrovascular accident

Datatyp

boolean

Alias
UMLS CUI [1]
C0007787
UMLS CUI [2]
C0038454
Tillbaka till toppen

Similar models

Eligibility Colorectal Neoplasms NCT00321100

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of colon metastatic Measurable | Adenocarcinoma of rectum metastatic Measurable
Item
measurable metastatic adenocarcinoma of the colon or rectum
boolean
C0338106 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C1513040 (UMLS CUI [1,3])
C0149978 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C1513040 (UMLS CUI [2,3])
systemic therapy Neoplasm Metastasis
Item
no prior systemic therapy for metastatic disease
boolean
C1515119 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Adjuvant therapy Completed | Recurrence | Therapeutic radiology procedure Completed
Item
adjuvant therapy must have been completed >/=12 months prior to recurrence, prior radiotherapy permitted but must have been completed > 6 months prior to study entry
boolean
C0677850 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0034897 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
Tumor tissue Available Epidermal Growth Factor Receptor Evaluation | Tumor tissue Available Thymidine Phosphorylase Evaluation
Item
must have tumor tissue available for egfr and thymidine phosphorylase evaluation
boolean
C0475358 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0034802 (UMLS CUI [1,3])
C1261322 (UMLS CUI [1,4])
C0475358 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C0040083 (UMLS CUI [2,3])
C1261322 (UMLS CUI [2,4])
ECOG performance status
Item
ecog ps 0-1
boolean
C1520224 (UMLS CUI [1])
Age
Item
age >/= 18
boolean
C0001779 (UMLS CUI [1])
Organ function | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine clearance measurement
Item
adequate organ function: wbc>/=3,000, anc >/=1,500, platelets>/= 100,000, total bilirubin </= 1.5x uln, ast&alt </= 2.5x uln, create clearance >/= 50ml/min
boolean
C0678852 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
C0373595 (UMLS CUI [8])
Childbearing Potential Pregnancy test negative
Item
negative pregnancy test w/in 72 hours of treatment for women of child bearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Informed Consent
Item
ability to understand and willing to sign written icf
boolean
C0021430 (UMLS CUI [1])
Able to swallow oral medication | Oral medication Absorption Ability
Item
able to swallow and absorb oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0175795 (UMLS CUI [2,1])
C0237442 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Medical condition Study Subject Participation Status At risk | Mental condition Study Subject Participation Status At risk | Uncontrolled hypertension | Myocardial Infarction | CNS disorder | Pregnancy | Breast Feeding
Item
medical or psychiatric condition which would potentially pose risk to patient by participation (i.e. but not limited to:uncontrolled hypertension, mi w/in 6 months,cns disease, pregnancy or nursing)
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C1868885 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0007682 (UMLS CUI [5])
C0032961 (UMLS CUI [6])
C0006147 (UMLS CUI [7])
Neoplasms | Skin carcinoma nonmetastatic | Carcinoma in situ of uterine cervix
Item
history of neoplasm (other than non-metastatic skin cancer or carcinoma in situ of cervix) w/in 5 years
boolean
C0027651 (UMLS CUI [1])
C0699893 (UMLS CUI [2,1])
C1518409 (UMLS CUI [2,2])
C0851140 (UMLS CUI [3])
Operative Surgical Procedures | Biopsy Closed | Injection/Infusion Ports Implantation | Incisional biopsy | Traumatic injury | Operative Surgical Procedures Patient need for | Fine needle aspiration biopsy | Core needle biopsy
Item
surgical procedure (not including closed biopsy or access port placement), open biopsy, significant traumatic injury w/in 28 days of registration or anticipation of need for surgical procedure while on study, fine needle aspiration or core biopsy w/in 7 days of registration
boolean
C0543467 (UMLS CUI [1])
C0005558 (UMLS CUI [2,1])
C0677512 (UMLS CUI [2,2])
C0042371 (UMLS CUI [3,1])
C0021107 (UMLS CUI [3,2])
C0184922 (UMLS CUI [4])
C3263723 (UMLS CUI [5])
C0543467 (UMLS CUI [6,1])
C0686904 (UMLS CUI [6,2])
C1510483 (UMLS CUI [7])
C1318309 (UMLS CUI [8])
Urine protein/creatinine ratio measurement
Item
urine protein:creatinine ration >/=1.0 at screening
boolean
C1096054 (UMLS CUI [1])
Bleeding tendency Evidence of | Blood Coagulation Disorders | Anticoagulation Therapy Absent
Item
evidence of bleeding diathesis or coagulopathy (in absence of anticoagulation)
boolean
C1458140 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0005779 (UMLS CUI [2])
C0003281 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Infusion related reaction Severe Monoclonal Antibodies | Allergic Reaction capecitabine | Allergic Reaction oxaliplatin
Item
prior severe infusion reaction to mab or allergic reaction to capecitabine or oxaliplatin
boolean
C0948715 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0003250 (UMLS CUI [1,3])
C1527304 (UMLS CUI [2,1])
C0671970 (UMLS CUI [2,2])
C1527304 (UMLS CUI [3,1])
C0069717 (UMLS CUI [3,2])
Neuropathy CTCAE Grades
Item
underlying neuropathy >/= grade 2
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Transient Ischemic Attack | Cerebrovascular accident
Item
tia or cva w/in 6 months
boolean
C0007787 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
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