ID

31228

Description

Phase II of Zactima Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00777179

Link

https://clinicaltrials.gov/show/NCT00777179

Keywords

Versions (1)
  1. 7/31/18 7/31/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 31, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility NSCLC NCT00777179

English

Eligibility NSCLC NCT00777179

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility NSCLC NCT00777179
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic or cytologic confirmation of locally advanced or metastatic nsclc (iiib-iv) at the time of original diagnosis.
Description

Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [1,4]
C3258246
UMLS CUI [2,1]
C0278987
UMLS CUI [2,2]
C3258246
completion of 4 cycles of chemotherapy of gemcitabine (1,000 or 1250mg/m^2/day on day 1 and 8) and cisplatin (70-80mg/m^2/day on day 1) every 3 weeks and have shown response, complete response(cr), partial response (pr) or stable disease (sd) by recist.
Description

Chemotherapy cycle Quantity Completed | Gemcitabine U/day | Cisplatin U/day | Disease Response | In complete remission | Partial response | Stable Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0045093
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C0008838
UMLS CUI [3,2]
C0456683
UMLS CUI [4]
C1704632
UMLS CUI [5]
C0677874
UMLS CUI [6]
C1521726
UMLS CUI [7]
C0677946
who ps 0-1
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
no prior radiotherapy to chest, immunotherapy or biologic therapy
Description

Radiotherapy to thorax Absent | Immunotherapy Absent | Biological treatment Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C4038705
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0021083
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1531518
UMLS CUI [3,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
mixed small cell and non small-cell lung cancer history.
Description

Medical History Mixed | Small cell carcinoma of lung | Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0205430
UMLS CUI [2]
C0149925
UMLS CUI [3]
C0007131
prior treatment with egfr tkis or vegfr tkis (prior treatment with cetuximab [erbitux] or bevacizumab [avastin] is not permitted.)
Description

Epidermal growth factor receptor inhibitor | VEGFR Tyrosine Kinase Inhibitor | cetuximab | Erbitux | bevacizumab | Avastin

Data type

boolean

Alias
UMLS CUI [1]
C1443775
UMLS CUI [2]
C2985521
UMLS CUI [3]
C0995188
UMLS CUI [4]
C1173436
UMLS CUI [5]
C0796392
UMLS CUI [6]
C1135130
evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol.
Description

Systemic disease Severe Study Subject Participation Status Unfavorable | Systemic disease Uncontrolled Study Subject Participation Status Unfavorable | Condition Study Subject Participation Status Unfavorable | Systemic disease Severe compromises Protocol Compliance | Systemic disease Uncontrolled compromises Protocol Compliance | Condition compromises Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C3640815
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C3640815
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C3640815
UMLS CUI [4,1]
C0442893
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C2945640
UMLS CUI [4,4]
C0525058
UMLS CUI [5,1]
C0442893
UMLS CUI [5,2]
C0205318
UMLS CUI [5,3]
C2945640
UMLS CUI [5,4]
C0525058
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C2945640
UMLS CUI [6,3]
C0525058
radiation therapy within 4 weeks before the start of study therapy. major surgery within 4 weeks, or incomplete healed surgical incision before starting study therapy.
Description

Therapeutic radiology procedure | Major surgery | Surgical incision Healed Incomplete

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0679637
UMLS CUI [3,1]
C0184898
UMLS CUI [3,2]
C0205249
UMLS CUI [3,3]
C0205257
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Similar models

Eligibility NSCLC NCT00777179

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility NSCLC NCT00777179
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging
Item
histologic or cytologic confirmation of locally advanced or metastatic nsclc (iiib-iv) at the time of original diagnosis.
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0278987 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Chemotherapy cycle Quantity Completed | Gemcitabine U/day | Cisplatin U/day | Disease Response | In complete remission | Partial response | Stable Disease
Item
completion of 4 cycles of chemotherapy of gemcitabine (1,000 or 1250mg/m^2/day on day 1 and 8) and cisplatin (70-80mg/m^2/day on day 1) every 3 weeks and have shown response, complete response(cr), partial response (pr) or stable disease (sd) by recist.
boolean
C1302181 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0045093 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0008838 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C1704632 (UMLS CUI [4])
C0677874 (UMLS CUI [5])
C1521726 (UMLS CUI [6])
C0677946 (UMLS CUI [7])
WHO performance status scale
Item
who ps 0-1
boolean
C1298650 (UMLS CUI [1])
Radiotherapy to thorax Absent | Immunotherapy Absent | Biological treatment Absent
Item
no prior radiotherapy to chest, immunotherapy or biologic therapy
boolean
C4038705 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1531518 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Medical History Mixed | Small cell carcinoma of lung | Non-Small Cell Lung Carcinoma
Item
mixed small cell and non small-cell lung cancer history.
boolean
C0262926 (UMLS CUI [1,1])
C0205430 (UMLS CUI [1,2])
C0149925 (UMLS CUI [2])
C0007131 (UMLS CUI [3])
Epidermal growth factor receptor inhibitor | VEGFR Tyrosine Kinase Inhibitor | cetuximab | Erbitux | bevacizumab | Avastin
Item
prior treatment with egfr tkis or vegfr tkis (prior treatment with cetuximab [erbitux] or bevacizumab [avastin] is not permitted.)
boolean
C1443775 (UMLS CUI [1])
C2985521 (UMLS CUI [2])
C0995188 (UMLS CUI [3])
C1173436 (UMLS CUI [4])
C0796392 (UMLS CUI [5])
C1135130 (UMLS CUI [6])
Systemic disease Severe Study Subject Participation Status Unfavorable | Systemic disease Uncontrolled Study Subject Participation Status Unfavorable | Condition Study Subject Participation Status Unfavorable | Systemic disease Severe compromises Protocol Compliance | Systemic disease Uncontrolled compromises Protocol Compliance | Condition compromises Protocol Compliance
Item
evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol.
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3640815 (UMLS CUI [1,4])
C0442893 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C3640815 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C3640815 (UMLS CUI [3,3])
C0442893 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C2945640 (UMLS CUI [4,3])
C0525058 (UMLS CUI [4,4])
C0442893 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C2945640 (UMLS CUI [5,3])
C0525058 (UMLS CUI [5,4])
C0348080 (UMLS CUI [6,1])
C2945640 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
Therapeutic radiology procedure | Major surgery | Surgical incision Healed Incomplete
Item
radiation therapy within 4 weeks before the start of study therapy. major surgery within 4 weeks, or incomplete healed surgical incision before starting study therapy.
boolean
C1522449 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
C0184898 (UMLS CUI [3,1])
C0205249 (UMLS CUI [3,2])
C0205257 (UMLS CUI [3,3])
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