ID

22122

Beskrivning

A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors; ODM derived from: https://clinicaltrials.gov/show/NCT00373425

Länk

https://clinicaltrials.gov/show/NCT00373425

Nyckelord

Versioner (1)
  1. 2017-05-20 2017-05-20 -
Uppladdad den

20 maj 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer DRKS00001485 NCT00373425

Engelsk

Eligibility Non-small Cell Lung Cancer NCT00373425

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
primary tissue from patient's surgery must be epidermal growth factor receptor (egfr)-positive by certain tests
Beskrivning

Operative Surgical Procedures Tissue Primary | Epidermal Growth Factor Receptor Positive Test Result

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0040300
UMLS CUI [1,3]
C0205225
UMLS CUI [2,1]
C0034802
UMLS CUI [2,2]
C1514241
UMLS CUI [2,3]
C0456984
patients may have up to 4 cycles of chemotherapy after surgery
Beskrivning

Chemotherapy cycle Quantity Postoperative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0032790
complete removal of the tumor by surgery
Beskrivning

Malignant Neoplasm Complete excision

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0015250
able to start drug under the following timelines:
Beskrivning

Medication start Timeline Able

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0451613
UMLS CUI [1,2]
C1705821
UMLS CUI [1,3]
C0085732
6 months from the day of surgery for patients who get chemotherapy
Beskrivning

Operative Surgical Procedures Timeline | Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1705821
UMLS CUI [2]
C0392920
3 months from the day of surgery for those who do not get chemotherapy
Beskrivning

Operative Surgical Procedures Timeline | Chemotherapy Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1705821
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332197
confirmed diagnosis of stage ib-iiia nsclc
Beskrivning

Non-Small Cell Lung Carcinoma TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
patients must be accessible for follow-up visits
Beskrivning

Clinical Study Follow-up Patient Available

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0470187
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of prior radiotherapy for nsclc either before or after surgery
Beskrivning

Therapeutic radiology procedure Non-Small Cell Lung Carcinoma Preoperative | Therapeutic radiology procedure Non-Small Cell Lung Carcinoma Postoperative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0007131
UMLS CUI [1,3]
C0445204
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0007131
UMLS CUI [2,3]
C0032790
history of heart disease or uncontrolled heart arrhythmias within the previous year
Beskrivning

Heart Disease | Cardiac Arrhythmia Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205318
history of poorly controlled gastrointestinal (gi) disorders that could affect the absorption of study drug
Beskrivning

Gastrointestinal Diseases Poorly controlled | Investigational New Drug Absorption Affected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C3853134
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0237442
UMLS CUI [2,3]
C0392760
history of other cancer except certain skin or cervical cancers, patients who have had other cancer are eligible if they have remained disease free for at least 5 years
Beskrivning

Malignant Neoplasms | Skin carcinoma | Cervix carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0302592
patients who have received chemotherapy for nsclc before surgery
Beskrivning

Chemotherapy Non-Small Cell Lung Carcinoma Preoperative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0007131
UMLS CUI [1,3]
C0445204
tumors with mixed histology of nsclc and small cell lung cancer (sclc). patients with carcinoid tumors are not eligible.
Beskrivning

Malignant Neoplasms Histology Mixed | Non-Small Cell Lung Carcinoma | Small cell carcinoma of lung | Carcinoid Tumor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0344441
UMLS CUI [1,3]
C0205430
UMLS CUI [2]
C0007131
UMLS CUI [3]
C0149925
UMLS CUI [4]
C0007095
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Similar models

Eligibility Non-small Cell Lung Cancer NCT00373425

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Operative Surgical Procedures Tissue Primary | Epidermal Growth Factor Receptor Positive Test Result
Item
primary tissue from patient's surgery must be epidermal growth factor receptor (egfr)-positive by certain tests
boolean
C0543467 (UMLS CUI [1,1])
C0040300 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0034802 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0456984 (UMLS CUI [2,3])
Chemotherapy cycle Quantity Postoperative
Item
patients may have up to 4 cycles of chemotherapy after surgery
boolean
C1302181 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0032790 (UMLS CUI [1,3])
Malignant Neoplasm Complete excision
Item
complete removal of the tumor by surgery
boolean
C0006826 (UMLS CUI [1,1])
C0015250 (UMLS CUI [1,2])
Medication start Timeline Able
Item
able to start drug under the following timelines:
boolean
C0451613 (UMLS CUI [1,1])
C1705821 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
Operative Surgical Procedures Timeline | Chemotherapy
Item
6 months from the day of surgery for patients who get chemotherapy
boolean
C0543467 (UMLS CUI [1,1])
C1705821 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
Operative Surgical Procedures Timeline | Chemotherapy Absent
Item
3 months from the day of surgery for those who do not get chemotherapy
boolean
C0543467 (UMLS CUI [1,1])
C1705821 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
confirmed diagnosis of stage ib-iiia nsclc
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Clinical Study Follow-up Patient Available
Item
patients must be accessible for follow-up visits
boolean
C3274571 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure Non-Small Cell Lung Carcinoma Preoperative | Therapeutic radiology procedure Non-Small Cell Lung Carcinoma Postoperative
Item
history of prior radiotherapy for nsclc either before or after surgery
boolean
C1522449 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0445204 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
C0032790 (UMLS CUI [2,3])
Heart Disease | Cardiac Arrhythmia Uncontrolled
Item
history of heart disease or uncontrolled heart arrhythmias within the previous year
boolean
C0018799 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Gastrointestinal Diseases Poorly controlled | Investigational New Drug Absorption Affected
Item
history of poorly controlled gastrointestinal (gi) disorders that could affect the absorption of study drug
boolean
C0017178 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2,1])
C0237442 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
Malignant Neoplasms | Skin carcinoma | Cervix carcinoma
Item
history of other cancer except certain skin or cervical cancers, patients who have had other cancer are eligible if they have remained disease free for at least 5 years
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0302592 (UMLS CUI [3])
Chemotherapy Non-Small Cell Lung Carcinoma Preoperative
Item
patients who have received chemotherapy for nsclc before surgery
boolean
C0392920 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0445204 (UMLS CUI [1,3])
Malignant Neoplasms Histology Mixed | Non-Small Cell Lung Carcinoma | Small cell carcinoma of lung | Carcinoid Tumor
Item
tumors with mixed histology of nsclc and small cell lung cancer (sclc). patients with carcinoid tumors are not eligible.
boolean
C0006826 (UMLS CUI [1,1])
C0344441 (UMLS CUI [1,2])
C0205430 (UMLS CUI [1,3])
C0007131 (UMLS CUI [2])
C0149925 (UMLS CUI [3])
C0007095 (UMLS CUI [4])
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