ID

20180

Description

Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT00411450

Link

https://clinicaltrials.gov/show/NCT00411450

Keywords

  1. 2/10/17 2/10/17 -
Uploaded on

February 10, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Colon Cancer NCT00411450

Eligibility Colon Cancer NCT00411450

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of metastatic adenocarcinoma of the colon or rectum
Description

Adenocarcinoma of colon metastatic | Adenocarcinoma of rectum metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0338106
UMLS CUI [1,2]
C1522484
UMLS CUI [2,1]
C0149978
UMLS CUI [2,2]
C1522484
available paraffin-embedded tumor tissue
Description

Tumor tissue sample Paraffin Embedding Available

Data type

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0085185
UMLS CUI [1,3]
C0470187
failure of first line treatment containing fluoropyrimidine and oxaliplatin based chemotherapy with bevacizumab for mcrc
Description

Colorectal Carcinoma metastatic | First line treatment fluoropyrimidine failed | Chemotherapy oxaliplatin failed | Chemotherapy bevacizumab failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C1522484
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C0596581
UMLS CUI [2,3]
C0231175
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0069717
UMLS CUI [3,3]
C0231175
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C0796392
UMLS CUI [4,3]
C0231175
measurable disease
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
adequate hematologic, renal, hepatic and metabolic function
Description

Hematologic function | Renal function | Liver function | Metabolic function normal

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C0438212
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
radiotherapy ≤ 2 weeks prior to day 1 of cycle 1
Description

Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1522449
unresolved toxicity(ies) from prior anti cancer therapy that, in the opinion of the investigator, precludes the subject from study enrollment
Description

cancer treatment | Toxic effect resolution | Study Subject Participation Status Exclusion

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C1514893
UMLS CUI [3,1]
C2348568
UMLS CUI [3,2]
C2828389
prior irinotecan therapy. anti egfr therapy, or vaccine for the treatment of mcrc
Description

irinotecan Colorectal Carcinoma metastatic | EGFR Antibody Colorectal Carcinoma metastatic | Vaccines Colorectal Carcinoma metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0123931
UMLS CUI [1,2]
C0009402
UMLS CUI [1,3]
C1522484
UMLS CUI [2,1]
C4055105
UMLS CUI [2,2]
C0009402
UMLS CUI [2,3]
C1522484
UMLS CUI [3,1]
C0042210
UMLS CUI [3,2]
C0009402
UMLS CUI [3,3]
C1522484
cyp3a4 enzyme inducers, inhibitors, and substrates (eg, phenytoin, phenobarbital, carbamazepine, ketoconazole, rifampin, rifabutin, and st. john's wort) ≤ 2 weeks prior to day 1 of cycle 1
Description

CYP3A4 Inducers | CYP3A4 Inhibitors | CYP3A4 Substrate | Phenytoin | Phenobarbital | Carbamazepine | Ketoconazole | Rifampin | Rifabutin | Hypericum perforatum

Data type

boolean

Alias
UMLS CUI [1]
C3850041
UMLS CUI [2]
C3850053
UMLS CUI [3,1]
C3714798
UMLS CUI [3,2]
C3891814
UMLS CUI [4]
C0031507
UMLS CUI [5]
C0031412
UMLS CUI [6]
C0006949
UMLS CUI [7]
C0022625
UMLS CUI [8]
C0035608
UMLS CUI [9]
C0140575
UMLS CUI [10]
C0936242
infection requiring systemic anti infectives completed ≤ 2 weeks prior to day 1 of cycle 1
Description

Communicable Disease Requirement ANTIINFECTIVES FOR SYSTEMIC USE

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C3653775
clinically significant cardiovascular disease
Description

Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222
history of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis)
Description

Lung Diseases, Interstitial | Pneumonitis | Pulmonary Fibrosis

Data type

boolean

Alias
UMLS CUI [1]
C0206062
UMLS CUI [2]
C3714636
UMLS CUI [3]
C0034069
pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event ≤
Description

Pulmonary Embolism | Deep Vein Thrombosis | Thromboembolism

Data type

boolean

Alias
UMLS CUI [1]
C0034065
UMLS CUI [2]
C0149871
UMLS CUI [3]
C0040038
8 weeks prior to day 1 of cycle 1
Description

ID.14

Data type

boolean

any significant bleeding ≤6 weeks prior to day 1 of cycle 1, per the investigator's judgement
Description

Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0019080
gastroduodenal ulcer(s) determined by endoscopy to be active or uncontrolled gastrointestinal ulcer ≤ 4 weeks prior to day1 of cycle 1
Description

Peptic Ulcer Endoscopy | Gastrointestinal ulcer | Gastrointestinal ulcer Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0030920
UMLS CUI [1,2]
C0014245
UMLS CUI [2]
C0237938
UMLS CUI [3,1]
C0237938
UMLS CUI [3,2]
C0205318
any co morbid disease or condition that could increase the risk of toxicity (eg, dihydropyrimidine deficiency, significant ascites, or pleural effusion)
Description

Comorbidity Risk Increase Toxic effect | Condition Risk Increase Toxic effect | Dihydropyrimidine Dehydrogenase Deficiency | Ascites | Pleural effusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C0442805
UMLS CUI [1,4]
C0600688
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C0442805
UMLS CUI [2,4]
C0600688
UMLS CUI [3]
C1959620
UMLS CUI [4]
C0003962
UMLS CUI [5]
C0032227
major surgery (requiring general anesthesia), open biopsy, or significant traumatic injury ≤4 weeks prior to day1 of cycle 1. subjects must have recovered from surgery and have no significant complications
Description

Major surgery Requirement General Anesthesia | Incisional biopsy | Traumatic injury | Operative Surgical Procedures Recovered | Complication Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0002915
UMLS CUI [2]
C0184922
UMLS CUI [3]
C3263723
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C0521108
UMLS CUI [5,1]
C0009566
UMLS CUI [5,2]
C0332197

Similar models

Eligibility Colon Cancer NCT00411450

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of colon metastatic | Adenocarcinoma of rectum metastatic
Item
diagnosis of metastatic adenocarcinoma of the colon or rectum
boolean
C0338106 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C0149978 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
Tumor tissue sample Paraffin Embedding Available
Item
available paraffin-embedded tumor tissue
boolean
C0475358 (UMLS CUI [1,1])
C0085185 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
Colorectal Carcinoma metastatic | First line treatment fluoropyrimidine failed | Chemotherapy oxaliplatin failed | Chemotherapy bevacizumab failed
Item
failure of first line treatment containing fluoropyrimidine and oxaliplatin based chemotherapy with bevacizumab for mcrc
boolean
C0009402 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C1708063 (UMLS CUI [2,1])
C0596581 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C0069717 (UMLS CUI [3,2])
C0231175 (UMLS CUI [3,3])
C0392920 (UMLS CUI [4,1])
C0796392 (UMLS CUI [4,2])
C0231175 (UMLS CUI [4,3])
Measurable Disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
Hematologic function | Renal function | Liver function | Metabolic function normal
Item
adequate hematologic, renal, hepatic and metabolic function
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0438212 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure
Item
radiotherapy ≤ 2 weeks prior to day 1 of cycle 1
boolean
C1522449 (UMLS CUI [1])
cancer treatment | Toxic effect resolution | Study Subject Participation Status Exclusion
Item
unresolved toxicity(ies) from prior anti cancer therapy that, in the opinion of the investigator, precludes the subject from study enrollment
boolean
C0920425 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C1514893 (UMLS CUI [2,2])
C2348568 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
irinotecan Colorectal Carcinoma metastatic | EGFR Antibody Colorectal Carcinoma metastatic | Vaccines Colorectal Carcinoma metastatic
Item
prior irinotecan therapy. anti egfr therapy, or vaccine for the treatment of mcrc
boolean
C0123931 (UMLS CUI [1,1])
C0009402 (UMLS CUI [1,2])
C1522484 (UMLS CUI [1,3])
C4055105 (UMLS CUI [2,1])
C0009402 (UMLS CUI [2,2])
C1522484 (UMLS CUI [2,3])
C0042210 (UMLS CUI [3,1])
C0009402 (UMLS CUI [3,2])
C1522484 (UMLS CUI [3,3])
CYP3A4 Inducers | CYP3A4 Inhibitors | CYP3A4 Substrate | Phenytoin | Phenobarbital | Carbamazepine | Ketoconazole | Rifampin | Rifabutin | Hypericum perforatum
Item
cyp3a4 enzyme inducers, inhibitors, and substrates (eg, phenytoin, phenobarbital, carbamazepine, ketoconazole, rifampin, rifabutin, and st. john's wort) ≤ 2 weeks prior to day 1 of cycle 1
boolean
C3850041 (UMLS CUI [1])
C3850053 (UMLS CUI [2])
C3714798 (UMLS CUI [3,1])
C3891814 (UMLS CUI [3,2])
C0031507 (UMLS CUI [4])
C0031412 (UMLS CUI [5])
C0006949 (UMLS CUI [6])
C0022625 (UMLS CUI [7])
C0035608 (UMLS CUI [8])
C0140575 (UMLS CUI [9])
C0936242 (UMLS CUI [10])
Communicable Disease Requirement ANTIINFECTIVES FOR SYSTEMIC USE
Item
infection requiring systemic anti infectives completed ≤ 2 weeks prior to day 1 of cycle 1
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C3653775 (UMLS CUI [1,3])
Cardiovascular Disease
Item
clinically significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Lung Diseases, Interstitial | Pneumonitis | Pulmonary Fibrosis
Item
history of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis)
boolean
C0206062 (UMLS CUI [1])
C3714636 (UMLS CUI [2])
C0034069 (UMLS CUI [3])
Pulmonary Embolism | Deep Vein Thrombosis | Thromboembolism
Item
pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event ≤
boolean
C0034065 (UMLS CUI [1])
C0149871 (UMLS CUI [2])
C0040038 (UMLS CUI [3])
ID.14
Item
8 weeks prior to day 1 of cycle 1
boolean
Hemorrhage
Item
any significant bleeding ≤6 weeks prior to day 1 of cycle 1, per the investigator's judgement
boolean
C0019080 (UMLS CUI [1])
Peptic Ulcer Endoscopy | Gastrointestinal ulcer | Gastrointestinal ulcer Uncontrolled
Item
gastroduodenal ulcer(s) determined by endoscopy to be active or uncontrolled gastrointestinal ulcer ≤ 4 weeks prior to day1 of cycle 1
boolean
C0030920 (UMLS CUI [1,1])
C0014245 (UMLS CUI [1,2])
C0237938 (UMLS CUI [2])
C0237938 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Comorbidity Risk Increase Toxic effect | Condition Risk Increase Toxic effect | Dihydropyrimidine Dehydrogenase Deficiency | Ascites | Pleural effusion
Item
any co morbid disease or condition that could increase the risk of toxicity (eg, dihydropyrimidine deficiency, significant ascites, or pleural effusion)
boolean
C0009488 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0442805 (UMLS CUI [1,3])
C0600688 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0442805 (UMLS CUI [2,3])
C0600688 (UMLS CUI [2,4])
C1959620 (UMLS CUI [3])
C0003962 (UMLS CUI [4])
C0032227 (UMLS CUI [5])
Major surgery Requirement General Anesthesia | Incisional biopsy | Traumatic injury | Operative Surgical Procedures Recovered | Complication Absent
Item
major surgery (requiring general anesthesia), open biopsy, or significant traumatic injury ≤4 weeks prior to day1 of cycle 1. subjects must have recovered from surgery and have no significant complications
boolean
C0679637 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0002915 (UMLS CUI [1,3])
C0184922 (UMLS CUI [2])
C3263723 (UMLS CUI [3])
C0543467 (UMLS CUI [4,1])
C0521108 (UMLS CUI [4,2])
C0009566 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])

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