ID

20180

Beschrijving

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

Trefwoorden

Versies (1)
  1. 10-02-17 10-02-17 -
Geüploaded op

10 februari 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Colon Cancer NCT00411450

Engels

Eligibility Colon Cancer NCT00411450

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Adenocarcinoma of colon metastatic | Adenocarcinoma of rectum metastatic

Datatype

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
Beschrijving

Tumor tissue sample Paraffin Embedding Available

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Measurable Disease

Datatype

boolean

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

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

Datatype

boolean

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

Exclusion Criteria

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

Therapeutic radiology procedure

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Communicable Disease Requirement ANTIINFECTIVES FOR SYSTEMIC USE

Datatype

boolean

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

Cardiovascular Disease

Datatype

boolean

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

Lung Diseases, Interstitial | Pneumonitis | Pulmonary Fibrosis

Datatype

boolean

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

Pulmonary Embolism | Deep Vein Thrombosis | Thromboembolism

Datatype

boolean

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

ID.14

Datatype

boolean

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

Hemorrhage

Datatype

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
Beschrijving

Peptic Ulcer Endoscopy | Gastrointestinal ulcer | Gastrointestinal ulcer Uncontrolled

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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
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Similar models

Eligibility Colon Cancer NCT00411450

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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