ID

28134

Beskrivning

PEAK: Panitumumab Plus mFOLFOX6 vs. Bevacizumab Plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer (mCRC) Patients With Wild-Type Kirsten Rat Sarcoma-2 Virus (KRAS) Tumors; ODM derived from: https://clinicaltrials.gov/show/NCT00819780

Länk

https://clinicaltrials.gov/show/NCT00819780

Nyckelord

Versioner (2)
  1. 2017-12-20 2017-12-20 -
  2. 2017-12-20 2017-12-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 december 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Colon Cancer NCT00819780

Engelsk

Eligibility Colon Cancer NCT00819780

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically-confirmed adenocarcinoma of the colon or rectum in patients with unresectable metastatic (m1) disease
Beskrivning

Adenocarcinoma of colon | Adenocarcinoma of rectum | Neoplasm Metastasis TNM clinical staging unresectable

Datatyp

boolean

Alias
UMLS CUI [1]
C0338106
UMLS CUI [2]
C0149978
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C3258246
UMLS CUI [3,3]
C1519810
patients with at least 1 uni-dimensionally measurable lesion of at least 10 mm per modified response evaluation criteria in solid tumors (recist) guidelines
Beskrivning

Measurable lesion Linear Quantity | Measurable lesion Size

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0456389
wild-type kras tumor status confirmed by an amgen approved central laboratory or an experienced laboratory (local laboratory) per local regulatory guidelines using a validated test method
Beskrivning

Tumor status Wild Type KRAS gene | Test Method Validation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475752
UMLS CUI [1,2]
C1883559
UMLS CUI [1,3]
C1537502
UMLS CUI [2,1]
C0871511
UMLS CUI [2,2]
C1519941
eastern cooperative oncology group (ecog) score of 0 or 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
men or women 18 years of age or older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
adequate hematologic, renal, hepatic, metabolic, and coagulation function
Beskrivning

Hematologic function | Renal function | Liver function | Metabolic function normal | Coagulation function analysis

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C0438212
UMLS CUI [5]
C3516400
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of prior or concurrent central nervous system (cns) metastases
Beskrivning

CNS metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
prior chemotherapy or other systemic anticancer therapy for treatment of metastatic colorectal carcinoma
Beskrivning

Prior Chemotherapy Colorectal Carcinoma metastatic | Cancer treatment Systemic Colorectal cancer metastatic

Datatyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0205373
UMLS CUI [2,3]
C0948380
clinically significant cardiac disease
Beskrivning

Heart Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
clinically significant peripheral sensory neuropathy
Beskrivning

Sensory neuropathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0151313
active inflammatory bowel disease
Beskrivning

Inflammatory Bowel Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0021390
recent gastroduodenal ulcer to be active or uncontrolled
Beskrivning

Peptic Ulcer | Peptic Ulcer Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2,1]
C0030920
UMLS CUI [2,2]
C0205318
history of interstitial lung disease
Beskrivning

Lung Diseases, Interstitial

Datatyp

boolean

Alias
UMLS CUI [1]
C0206062
recent pulmonary embolism, deep vein thrombosis, or other significant venous event
Beskrivning

Pulmonary Embolism | Deep Vein Thrombosis | Disorder of vein

Datatyp

boolean

Alias
UMLS CUI [1]
C0034065
UMLS CUI [2]
C0149871
UMLS CUI [3]
C0235522
pre-existing bleeding diathesis and/or coagulopathy with exception of well-controlled anticoagulation therapy
Beskrivning

Bleeding tendency Pre-existing | Blood Coagulation Disorders Pre-existing | Exception Anticoagulation Therapy Well controlled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1458140
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C0005779
UMLS CUI [2,2]
C2347662
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0003281
UMLS CUI [3,3]
C3853142
recent major surgical procedure, open biopsy, or significant traumatic injury not yet recovered from prior major surgery.
Beskrivning

Major surgery | Incisional biopsy | Traumatic injury | Major surgery Previous Recovery Lacking

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0184922
UMLS CUI [3]
C3263723
UMLS CUI [4,1]
C0679637
UMLS CUI [4,2]
C0205156
UMLS CUI [4,3]
C2004454
UMLS CUI [4,4]
C0332268
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Similar models

Eligibility Colon Cancer NCT00819780

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of colon | Adenocarcinoma of rectum | Neoplasm Metastasis TNM clinical staging unresectable
Item
histologically or cytologically-confirmed adenocarcinoma of the colon or rectum in patients with unresectable metastatic (m1) disease
boolean
C0338106 (UMLS CUI [1])
C0149978 (UMLS CUI [2])
C0027627 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
C1519810 (UMLS CUI [3,3])
Measurable lesion Linear Quantity | Measurable lesion Size
Item
patients with at least 1 uni-dimensionally measurable lesion of at least 10 mm per modified response evaluation criteria in solid tumors (recist) guidelines
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
Tumor status Wild Type KRAS gene | Test Method Validation
Item
wild-type kras tumor status confirmed by an amgen approved central laboratory or an experienced laboratory (local laboratory) per local regulatory guidelines using a validated test method
boolean
C0475752 (UMLS CUI [1,1])
C1883559 (UMLS CUI [1,2])
C1537502 (UMLS CUI [1,3])
C0871511 (UMLS CUI [2,1])
C1519941 (UMLS CUI [2,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) score of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Age
Item
men or women 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Hematologic function | Renal function | Liver function | Metabolic function normal | Coagulation function analysis
Item
adequate hematologic, renal, hepatic, metabolic, and coagulation function
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0438212 (UMLS CUI [4])
C3516400 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
CNS metastases
Item
history of prior or concurrent central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1])
Prior Chemotherapy Colorectal Carcinoma metastatic | Cancer treatment Systemic Colorectal cancer metastatic
Item
prior chemotherapy or other systemic anticancer therapy for treatment of metastatic colorectal carcinoma
boolean
C1514457 (UMLS CUI [1])
C0920425 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0948380 (UMLS CUI [2,3])
Heart Disease
Item
clinically significant cardiac disease
boolean
C0018799 (UMLS CUI [1])
Sensory neuropathy
Item
clinically significant peripheral sensory neuropathy
boolean
C0151313 (UMLS CUI [1])
Inflammatory Bowel Disease
Item
active inflammatory bowel disease
boolean
C0021390 (UMLS CUI [1])
Peptic Ulcer | Peptic Ulcer Uncontrolled
Item
recent gastroduodenal ulcer to be active or uncontrolled
boolean
C0030920 (UMLS CUI [1])
C0030920 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Lung Diseases, Interstitial
Item
history of interstitial lung disease
boolean
C0206062 (UMLS CUI [1])
Pulmonary Embolism | Deep Vein Thrombosis | Disorder of vein
Item
recent pulmonary embolism, deep vein thrombosis, or other significant venous event
boolean
C0034065 (UMLS CUI [1])
C0149871 (UMLS CUI [2])
C0235522 (UMLS CUI [3])
Bleeding tendency Pre-existing | Blood Coagulation Disorders Pre-existing | Exception Anticoagulation Therapy Well controlled
Item
pre-existing bleeding diathesis and/or coagulopathy with exception of well-controlled anticoagulation therapy
boolean
C1458140 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0005779 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0003281 (UMLS CUI [3,2])
C3853142 (UMLS CUI [3,3])
Major surgery | Incisional biopsy | Traumatic injury | Major surgery Previous Recovery Lacking
Item
recent major surgical procedure, open biopsy, or significant traumatic injury not yet recovered from prior major surgery.
boolean
C0679637 (UMLS CUI [1])
C0184922 (UMLS CUI [2])
C3263723 (UMLS CUI [3])
C0679637 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C2004454 (UMLS CUI [4,3])
C0332268 (UMLS CUI [4,4])
Tillbaka till toppen 

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