ID

22190

Beschreibung

Study of Gemcitabine/Platinum +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00112346

Link

https://clinicaltrials.gov/show/NCT00112346

Stichworte

Versionen (1)
  1. 22.05.17 22.05.17 -
Hochgeladen am

22. Mai 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Non-Small-Cell Lung Carcinoma NCT00112346

Englisch

Eligibility Non-Small-Cell Lung Carcinoma NCT00112346

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy.
Beschreibung

Non-Small Cell Lung Carcinoma Advanced | Non-small cell lung cancer metastatic | Prior Chemotherapy Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C0278987
UMLS CUI [3,1]
C1514457
UMLS CUI [3,2]
C0332197
must not have received cetuximab or any medications that target the same pathway as cetuximab (such as iressa or tarceva).
Beschreibung

Cetuximab Absent | Iressa Absent | Tarceva Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0995188
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0919281
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1135136
UMLS CUI [3,2]
C0332197
must not have had hypersensitivity or severe allergic reactions to any monoclonal antibodies and must not have severe restrictive or interstitial lung disease.
Beschreibung

Monoclonal Antibodies Hypersensitivity Absent | Monoclonal Antibodies Allergic Reaction Severe Absent | Restrictive lung disease Severe Absent | Interstitial Lung Diseases Severe Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003250
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0003250
UMLS CUI [2,2]
C1527304
UMLS CUI [2,3]
C0205082
UMLS CUI [2,4]
C0332197
UMLS CUI [3,1]
C0085581
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0206062
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0332197
must be able to carry out work of light or sedentary nature (e.g. light house work, office work).
Beschreibung

Light Work Perform Able | Light work around the house Perform Able | Work Sedentary Perform Ability

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2987220
UMLS CUI [1,2]
C0884358
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C3842657
UMLS CUI [2,2]
C0884358
UMLS CUI [2,3]
C0085732
UMLS CUI [3,1]
C0043227
UMLS CUI [3,2]
C0205254
UMLS CUI [3,3]
C0884358
UMLS CUI [3,4]
C0085732
it must be at least 4 weeks since last major surgery or prior treatment with an investigational product and at least 12 weeks from any radiation therapy to the chest.
Beschreibung

major surgery | Investigational New Drugs | Therapeutic radiology procedure Chest

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0013230
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0817096
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant or breastfeeding.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women with a positive pregnancy test on enrollment or prior to study drug administration.
Beschreibung

Gender Pregnancy test positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0240802
any concurrent malignancy (subjects with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial).
Beschreibung

Malignant Neoplasms | Malignant Neoplasm Previous Disease Free of

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0012634
UMLS CUI [2,4]
C0332296
symptomatic or uncontrolled metastases in the central nervous system (cns).
Beschreibung

CNS metastases Symptomatic | CNS metastases Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0205318
peripheral neuropathy.
Beschreibung

Peripheral Neuropathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0031117
inadequate hematologic function defined by an absolute neutrophil count (anc) <1,500/mm^3, a platelet count <100,000/mm^3, or a hemoglobin level < 9g/dl.
Beschreibung

Hematologic function Inadequate | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0205412
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
inadequate liver function.
Beschreibung

Liver Dysfunction

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
inadequate kidney function.
Beschreibung

Abnormal renal function

Datentyp

boolean

Alias
UMLS CUI [1]
C0151746
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Ähnliche Modelle

Eligibility Non-Small-Cell Lung Carcinoma NCT00112346

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced | Non-small cell lung cancer metastatic | Prior Chemotherapy Absent
Item
must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy.
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0278987 (UMLS CUI [2])
C1514457 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Cetuximab Absent | Iressa Absent | Tarceva Absent
Item
must not have received cetuximab or any medications that target the same pathway as cetuximab (such as iressa or tarceva).
boolean
C0995188 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0919281 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1135136 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Monoclonal Antibodies Hypersensitivity Absent | Monoclonal Antibodies Allergic Reaction Severe Absent | Restrictive lung disease Severe Absent | Interstitial Lung Diseases Severe Absent
Item
must not have had hypersensitivity or severe allergic reactions to any monoclonal antibodies and must not have severe restrictive or interstitial lung disease.
boolean
C0003250 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0003250 (UMLS CUI [2,1])
C1527304 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
C0085581 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0206062 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Light Work Perform Able | Light work around the house Perform Able | Work Sedentary Perform Ability
Item
must be able to carry out work of light or sedentary nature (e.g. light house work, office work).
boolean
C2987220 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C3842657 (UMLS CUI [2,1])
C0884358 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
C0043227 (UMLS CUI [3,1])
C0205254 (UMLS CUI [3,2])
C0884358 (UMLS CUI [3,3])
C0085732 (UMLS CUI [3,4])
major surgery | Investigational New Drugs | Therapeutic radiology procedure Chest
Item
it must be at least 4 weeks since last major surgery or prior treatment with an investigational product and at least 12 weeks from any radiation therapy to the chest.
boolean
C0679637 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C0817096 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender Pregnancy test positive
Item
women with a positive pregnancy test on enrollment or prior to study drug administration.
boolean
C0079399 (UMLS CUI [1,1])
C0240802 (UMLS CUI [1,2])
Malignant Neoplasms | Malignant Neoplasm Previous Disease Free of
Item
any concurrent malignancy (subjects with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial).
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0012634 (UMLS CUI [2,3])
C0332296 (UMLS CUI [2,4])
CNS metastases Symptomatic | CNS metastases Uncontrolled
Item
symptomatic or uncontrolled metastases in the central nervous system (cns).
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Peripheral Neuropathy
Item
peripheral neuropathy.
boolean
C0031117 (UMLS CUI [1])
Hematologic function Inadequate | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
inadequate hematologic function defined by an absolute neutrophil count (anc) <1,500/mm^3, a platelet count <100,000/mm^3, or a hemoglobin level < 9g/dl.
boolean
C0221130 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Liver Dysfunction
Item
inadequate liver function.
boolean
C0086565 (UMLS CUI [1])
Abnormal renal function
Item
inadequate kidney function.
boolean
C0151746 (UMLS CUI [1])
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