ID

21863

Description

PRIME: Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy; ODM derived from: https://clinicaltrials.gov/show/NCT00364013

Lien

https://clinicaltrials.gov/show/NCT00364013

Mots-clés

Versions (1)
  1. 04/05/2017 04/05/2017 -
Téléchargé le

4 mai 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer NCT00364013

Anglais

Eligibility Metastatic Colorectal Cancer NCT00364013

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
man or woman at least 18 years old
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of metastatic colorectal cancer
Description

Colorectal cancer metastatic

Type de données

boolean

Alias
UMLS CUI [1]
C0948380
at least 1 uni-dimensionally measurable lesion of at least 20 mm per modified recist
Description

Measurable lesion Linear Quantity | Measurable lesion Size

Type de données

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]
C0449453
eastern cooperative oncology group (ecog) performance status of 0, 1, or 2
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
paraffin-embedded tumor tissue from the primary tumor or metastasis available for central analyse exclusion criteria:
Description

Primary tumor Paraffin Embedded Tissue Available | Neoplasm Metastasis Paraffin Embedded Tissue Available | Exclusion Criteria

Type de données

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C1519524
UMLS CUI [1,3]
C0470187
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C1519524
UMLS CUI [2,3]
C0470187
UMLS CUI [3]
C0680251
history or known presence of central nervous system (cns) metastases
Description

CNS metastases

Type de données

boolean

Alias
UMLS CUI [1]
C0686377
history of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 5 years before randomization
Description

Primary malignant neoplasm | Curative treatment Carcinoma in situ of uterine cervix | Skin carcinoma Resected Curative | Curative treatment Solid tumour Primary

Type de données

boolean

Alias
UMLS CUI [1]
C1306459
UMLS CUI [2,1]
C1273390
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C0699893
UMLS CUI [3,2]
C1521996
UMLS CUI [3,3]
C1276305
UMLS CUI [4,1]
C1273390
UMLS CUI [4,2]
C0280100
UMLS CUI [4,3]
C0205225
prior chemotherapy or systemic therapy for the treatment of metastatic colorectal carcinoma except: adjuvant fluoropyrimidine-based chemotherapy or prior fluoropyrimidine therapy administered solely for the purpose of radiosensitization
Description

Chemotherapy Colorectal cancer metastatic | Systemic therapy Colorectal cancer metastatic | Adjuvant Chemotherapy Fluoropyrimidine Based | Fluoropyrimidine Radiosensitization Related

Type de données

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0948380
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0948380
UMLS CUI [3,1]
C0085533
UMLS CUI [3,2]
C0596581
UMLS CUI [3,3]
C1705938
UMLS CUI [4,1]
C0596581
UMLS CUI [4,2]
C0279024
UMLS CUI [4,3]
C0439849
prior oxaliplatin therapy
Description

oxaliplatin

Type de données

boolean

Alias
UMLS CUI [1]
C0069717
prior anti-epidermal growth factor receptor (egfr) antibody therapy (eg, cetuximab) or treatment with small molecule egfr inhibitors (eg, erlotinib)
Description

EGFR Antibody | cetuximab | Epidermal growth factor receptor inhibitor Small Molecule | erlotinib

Type de données

boolean

Alias
UMLS CUI [1]
C4055105
UMLS CUI [2]
C0995188
UMLS CUI [3,1]
C1443775
UMLS CUI [3,2]
C1328819
UMLS CUI [4]
C1135135
clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 1 year prior to randomization history of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computed tomography (ct) scan
Description

Cardiovascular Disease | Myocardial Infarction | Angina, Unstable | Symptomatic congestive heart failure | Cardiac Arrhythmia Uncontrolled Serious | Lung Diseases, Interstitial | Pneumonia | Pulmonary Fibrosis | Interstitial Lung Disease Evidence Chest CT

Type de données

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0742758
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C0205318
UMLS CUI [5,3]
C0205404
UMLS CUI [6]
C0206062
UMLS CUI [7]
C0032285
UMLS CUI [8]
C0034069
UMLS CUI [9,1]
C0206062
UMLS CUI [9,2]
C0332120
UMLS CUI [9,3]
C0202823
active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as > common terminology criteria (ctc) grade 2 [ctcae version 3.0])
Description

Inflammatory Bowel Disease | Intestinal Disease Causing Chronic diarrhea CTCAE Grades

Type de données

boolean

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2,1]
C0021831
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0401151
UMLS CUI [2,4]
C1516728
peripheral sensory neuropathy with functional impairment
Description

Peripheral sensory neuropathy | Impairment Functional

Type de données

boolean

Alias
UMLS CUI [1]
C0151313
UMLS CUI [2,1]
C0221099
UMLS CUI [2,2]
C0205245
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Similar models

Eligibility Metastatic Colorectal Cancer NCT00364013

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
man or woman at least 18 years old
boolean
C0001779 (UMLS CUI [1])
Colorectal cancer metastatic
Item
diagnosis of metastatic colorectal cancer
boolean
C0948380 (UMLS CUI [1])
Measurable lesion Linear Quantity | Measurable lesion Size
Item
at least 1 uni-dimensionally measurable lesion of at least 20 mm per modified recist
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C0449453 (UMLS CUI [2,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Primary tumor Paraffin Embedded Tissue Available | Neoplasm Metastasis Paraffin Embedded Tissue Available | Exclusion Criteria
Item
paraffin-embedded tumor tissue from the primary tumor or metastasis available for central analyse exclusion criteria:
boolean
C0677930 (UMLS CUI [1,1])
C1519524 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C1519524 (UMLS CUI [2,2])
C0470187 (UMLS CUI [2,3])
C0680251 (UMLS CUI [3])
CNS metastases
Item
history or known presence of central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1])
Primary malignant neoplasm | Curative treatment Carcinoma in situ of uterine cervix | Skin carcinoma Resected Curative | Curative treatment Solid tumour Primary
Item
history of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 5 years before randomization
boolean
C1306459 (UMLS CUI [1])
C1273390 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C0699893 (UMLS CUI [3,1])
C1521996 (UMLS CUI [3,2])
C1276305 (UMLS CUI [3,3])
C1273390 (UMLS CUI [4,1])
C0280100 (UMLS CUI [4,2])
C0205225 (UMLS CUI [4,3])
Chemotherapy Colorectal cancer metastatic | Systemic therapy Colorectal cancer metastatic | Adjuvant Chemotherapy Fluoropyrimidine Based | Fluoropyrimidine Radiosensitization Related
Item
prior chemotherapy or systemic therapy for the treatment of metastatic colorectal carcinoma except: adjuvant fluoropyrimidine-based chemotherapy or prior fluoropyrimidine therapy administered solely for the purpose of radiosensitization
boolean
C0392920 (UMLS CUI [1,1])
C0948380 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C0948380 (UMLS CUI [2,2])
C0085533 (UMLS CUI [3,1])
C0596581 (UMLS CUI [3,2])
C1705938 (UMLS CUI [3,3])
C0596581 (UMLS CUI [4,1])
C0279024 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
oxaliplatin
Item
prior oxaliplatin therapy
boolean
C0069717 (UMLS CUI [1])
EGFR Antibody | cetuximab | Epidermal growth factor receptor inhibitor Small Molecule | erlotinib
Item
prior anti-epidermal growth factor receptor (egfr) antibody therapy (eg, cetuximab) or treatment with small molecule egfr inhibitors (eg, erlotinib)
boolean
C4055105 (UMLS CUI [1])
C0995188 (UMLS CUI [2])
C1443775 (UMLS CUI [3,1])
C1328819 (UMLS CUI [3,2])
C1135135 (UMLS CUI [4])
Cardiovascular Disease | Myocardial Infarction | Angina, Unstable | Symptomatic congestive heart failure | Cardiac Arrhythmia Uncontrolled Serious | Lung Diseases, Interstitial | Pneumonia | Pulmonary Fibrosis | Interstitial Lung Disease Evidence Chest CT
Item
clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 1 year prior to randomization history of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computed tomography (ct) scan
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0742758 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0205404 (UMLS CUI [5,3])
C0206062 (UMLS CUI [6])
C0032285 (UMLS CUI [7])
C0034069 (UMLS CUI [8])
C0206062 (UMLS CUI [9,1])
C0332120 (UMLS CUI [9,2])
C0202823 (UMLS CUI [9,3])
Inflammatory Bowel Disease | Intestinal Disease Causing Chronic diarrhea CTCAE Grades
Item
active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as > common terminology criteria (ctc) grade 2 [ctcae version 3.0])
boolean
C0021390 (UMLS CUI [1])
C0021831 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0401151 (UMLS CUI [2,3])
C1516728 (UMLS CUI [2,4])
Peripheral sensory neuropathy | Impairment Functional
Item
peripheral sensory neuropathy with functional impairment
boolean
C0151313 (UMLS CUI [1])
C0221099 (UMLS CUI [2,1])
C0205245 (UMLS CUI [2,2])
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