ID

18503

Description

Trial Comparing 3 and 4 Week Regimen of Gemcitabine and Cisplatin in Patients With Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00489996

Link

https://clinicaltrials.gov/show/NCT00489996

Keywords

Versions (1)
  1. 11/8/16 11/8/16 -
Uploaded on

November 8, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT00489996

English

Eligibility Non-Small Cell Lung Cancer NCT00489996

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic or cytologic diagnosis of nsclc
Description

Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007131
presence of stage iiib or stage iv disease
Description

TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3258246
patients must have received no prior systemic chemotherapy
Description

Systemic Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1883256
patients must have at least one bi-dimensionally measurable lesion with clearly defined margins and two perpendicular diameters that are clearly measurable by any of the following: chest x-ray, with at least one diameter 1.0 cm or greater, ct, with both diameters greater than the distance between cuts of the imaging study, palpation, with both diameters 2.0 cm or greater, or disease progressing in areas of prior radiation therapy may be included
Description

Measurable Disease 2-Dimensional Quantity | Circumscribed lesion | Diameter Perpendicular Quantity | Plain chest X-ray | X-Ray Computed Tomography | Palpation | Disease Progression | prior radiation therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C1268666
UMLS CUI [3,1]
C1301886
UMLS CUI [3,2]
C3272860
UMLS CUI [3,3]
C1265611
UMLS CUI [4]
C0039985
UMLS CUI [5]
C0040405
UMLS CUI [6]
C0030247
UMLS CUI [7]
C0242656
UMLS CUI [8]
C0279134
no prior radiotherapy for the target organ, no other radiotherapy for at least 2 weeks prior to study enrollment and the patient must have fully recovered from all acute toxic effects of the treatment.
Description

Radiotherapy Target Organ Alignment | Therapeutic radiology procedure | Toxic effect Due to Therapeutic procedure | Patient Recovered

Data type

boolean

Alias
UMLS CUI [1]
C3179063
UMLS CUI [2]
C1522449
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0087111
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C0521108
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
Description

Research Personnel Affiliated Study | Immediate family Research Personnel Affiliated Study

Data type

boolean

Alias
UMLS CUI [1,1]
C0035173
UMLS CUI [1,2]
C1510826
UMLS CUI [1,3]
C2603343
UMLS CUI [2,1]
C2371717
UMLS CUI [2,2]
C0035173
UMLS CUI [2,3]
C1510826
UMLS CUI [2,4]
C2603343
are employed by lilly (that is, employees, temporary contract workers, or designees responsible for the conduct the study). immediate family of lilly employees may participate in lilly sponsored clinical trials, but are not permitted to participate at a lilly facility. immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
Description

lilly Employed | lilly Employee Immediate family | Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0331851
UMLS CUI [1,2]
C0557351
UMLS CUI [2,1]
C0331851
UMLS CUI [2,2]
C0599987
UMLS CUI [2,3]
C2371717
UMLS CUI [3]
C2348568
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Description

Non-Prescription Drugs Indication Any

Data type

boolean

Alias
UMLS CUI [1,1]
C0013231
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C1552551
have previously completed or withdrawn from this study or any other study investigating gemcitabine.
Description

Study Subject Participation Status | gemcitabine

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0045093
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT00489996

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
histologic or cytologic diagnosis of nsclc
boolean
C0007131 (UMLS CUI [1])
TNM clinical staging
Item
presence of stage iiib or stage iv disease
boolean
C3258246 (UMLS CUI [1])
Systemic Chemotherapy
Item
patients must have received no prior systemic chemotherapy
boolean
C1883256 (UMLS CUI [1])
Measurable Disease 2-Dimensional Quantity | Circumscribed lesion | Diameter Perpendicular Quantity | Plain chest X-ray | X-Ray Computed Tomography | Palpation | Disease Progression | prior radiation therapy
Item
patients must have at least one bi-dimensionally measurable lesion with clearly defined margins and two perpendicular diameters that are clearly measurable by any of the following: chest x-ray, with at least one diameter 1.0 cm or greater, ct, with both diameters greater than the distance between cuts of the imaging study, palpation, with both diameters 2.0 cm or greater, or disease progressing in areas of prior radiation therapy may be included
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1268666 (UMLS CUI [2])
C1301886 (UMLS CUI [3,1])
C3272860 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0039985 (UMLS CUI [4])
C0040405 (UMLS CUI [5])
C0030247 (UMLS CUI [6])
C0242656 (UMLS CUI [7])
C0279134 (UMLS CUI [8])
Radiotherapy Target Organ Alignment | Therapeutic radiology procedure | Toxic effect Due to Therapeutic procedure | Patient Recovered
Item
no prior radiotherapy for the target organ, no other radiotherapy for at least 2 weeks prior to study enrollment and the patient must have fully recovered from all acute toxic effects of the treatment.
boolean
C3179063 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0600688 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0030705 (UMLS CUI [4,1])
C0521108 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Research Personnel Affiliated Study | Immediate family Research Personnel Affiliated Study
Item
are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
boolean
C0035173 (UMLS CUI [1,1])
C1510826 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
C2371717 (UMLS CUI [2,1])
C0035173 (UMLS CUI [2,2])
C1510826 (UMLS CUI [2,3])
C2603343 (UMLS CUI [2,4])
lilly Employed | lilly Employee Immediate family | Study Subject Participation Status
Item
are employed by lilly (that is, employees, temporary contract workers, or designees responsible for the conduct the study). immediate family of lilly employees may participate in lilly sponsored clinical trials, but are not permitted to participate at a lilly facility. immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
boolean
C0331851 (UMLS CUI [1,1])
C0557351 (UMLS CUI [1,2])
C0331851 (UMLS CUI [2,1])
C0599987 (UMLS CUI [2,2])
C2371717 (UMLS CUI [2,3])
C2348568 (UMLS CUI [3])
Non-Prescription Drugs Indication Any
Item
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
boolean
C0013231 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Study Subject Participation Status | gemcitabine
Item
have previously completed or withdrawn from this study or any other study investigating gemcitabine.
boolean
C2348568 (UMLS CUI [1])
C0045093 (UMLS CUI [2])
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