ID

30259

Beschreibung

Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00527735

Link

https://clinicaltrials.gov/show/NCT00527735

Stichworte

Versionen (1)
  1. 25.05.18 25.05.18 -
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See clinicaltrials.gov

Hochgeladen am

25. Mai 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00527735

Englisch

Eligibility Lung Cancer NCT00527735

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed lung cancer (stage iiib/iv nonsmall-cell lung cancer or extensive stage small-cell lung cancer [sclc])
Beschreibung

Carcinoma of lung | Non-Small Cell Lung Carcinoma TNM clinical staging | Small cell lung cancer extensive stage

Datentyp

boolean

Alias
UMLS CUI [1]
C0684249
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C3258246
UMLS CUI [3]
C0278726
measurable tumor lesion (as long as it is not located in a previously irradiated area) as defined by modified world health organization criteria
Beschreibung

Measurable Disease | Exception Irradiation Area Previous

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1522449
UMLS CUI [2,3]
C0005902
UMLS CUI [2,4]
C0205156
eastern cooperative oncology group performance status of ≤1 at study entry
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
accessible for treatment and follow-up
Beschreibung

Accessibility Therapeutic procedure | Accessibility Follow-up

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0814423
UMLS CUI [1,2]
C0087111
UMLS CUI [2,1]
C0814423
UMLS CUI [2,2]
C3274571
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
brain metastases
Beschreibung

Metastatic malignant neoplasm to brain

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
malignant pleural effusion
Beschreibung

Pleural Effusion, Malignant

Datentyp

boolean

Alias
UMLS CUI [1]
C0080032
autoimmune disease
Beschreibung

Autoimmune Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
motor neuropathy of autoimmune origin
Beschreibung

Motor neuropathy Origin Autoimmune process

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0235025
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C0443146
sclc-related paraneoplastic syndromes
Beschreibung

Paraneoplastic Syndromes Relationship Small cell carcinoma of lung

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030472
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0149925
any concurrent malignancy other than nonmelanoma skin cancer; carcinoma in situ of the cervix or breast; or prostate cancer treated with systemic therapy (participants with a previous malignancy but without evidence of disease for 5 years were allowed to enter the study)
Beschreibung

Cancer Other | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast | Exception Systemic therapy Prostate carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0686288
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1515119
UMLS CUI [5,3]
C0600139
prior systemic therapy for lung cancer. prior radiation therapy or locoregional surgeries performed later than at least 3 weeks prior to randomization date were allowed.
Beschreibung

Systemic therapy Carcinoma of lung | Prior radiation therapy allowed | Operative Surgical Procedures Locoregional Previous allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0684249
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0683607
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C1947913
UMLS CUI [3,3]
C0205156
UMLS CUI [3,4]
C0683607
grade 2 peripheral neuropathy (motor or sensory)
Beschreibung

Peripheral motor neuropathy CTCAE Grades | Sensory neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0235025
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0151313
UMLS CUI [2,2]
C1516728
known hiv or hepatitis b or c infection
Beschreibung

HIV Infection | Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or noncancer-related illnesses). however, use of corticosteroids was allowed if used as premedication for paclitaxel infusion or for treating immune-related adverse events or adrenal insufficiencies.
Beschreibung

Immunosuppressive Agents chronic | CORTICOSTEROIDS FOR SYSTEMIC USE | Exception Paclitaxel Infusion | Exception Adverse event Relationship Immune system | Exception Adrenal Insufficiency Adverse Event

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C3653708
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0144576
UMLS CUI [3,3]
C0574032
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0877248
UMLS CUI [4,3]
C0439849
UMLS CUI [4,4]
C0020962
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1963059
inadequate hematologic function defined by an absolute neutrophil count <1,500/mm^3, a platelet count <100,000/mm^3, or hemoglobin level <9 g/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 hepatic function defined by a total bilirubin level >2.0 times the upper limit of normal (uln), or ≥2.5 times the uln if liver metastases are present, aspartate aminotransferase and alanine aminotransferase levels ≥2.5 times the uln or
Beschreibung

Liver function Inadequate | Elevated total bilirubin | Relationship Secondary malignant neoplasm of liver | Aspartate aminotransferase increased | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0205412
UMLS CUI [2]
C0741494
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0494165
UMLS CUI [4]
C0151904
UMLS CUI [5]
C0151905
≥5 times the uln if liver metastases are present.
Beschreibung

Aspartate aminotransferase increased | Alanine aminotransferase increased | Relationship Secondary malignant neoplasm of liver

Datentyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0494165
inadequate renal function defined by a serum creatinine level ≥2.5 times the uln
Beschreibung

Renal function Inadequate | Serum creatinine raised

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0205412
UMLS CUI [2]
C0700225
inadequate creatinine clearance defined as less than 50 ml/min.
Beschreibung

Creatinine clearance Inadequate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0812399
UMLS CUI [1,2]
C0205412
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Ähnliche Modelle

Eligibility Lung Cancer NCT00527735

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Carcinoma of lung | Non-Small Cell Lung Carcinoma TNM clinical staging | Small cell lung cancer extensive stage
Item
histologically or cytologically confirmed lung cancer (stage iiib/iv nonsmall-cell lung cancer or extensive stage small-cell lung cancer [sclc])
boolean
C0684249 (UMLS CUI [1])
C0007131 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0278726 (UMLS CUI [3])
Measurable Disease | Exception Irradiation Area Previous
Item
measurable tumor lesion (as long as it is not located in a previously irradiated area) as defined by modified world health organization criteria
boolean
C1513041 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0005902 (UMLS CUI [2,3])
C0205156 (UMLS CUI [2,4])
ECOG performance status
Item
eastern cooperative oncology group performance status of ≤1 at study entry
boolean
C1520224 (UMLS CUI [1])
Accessibility Therapeutic procedure | Accessibility Follow-up
Item
accessible for treatment and follow-up
boolean
C0814423 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0814423 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain
Item
brain metastases
boolean
C0220650 (UMLS CUI [1])
Pleural Effusion, Malignant
Item
malignant pleural effusion
boolean
C0080032 (UMLS CUI [1])
Autoimmune Disease
Item
autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Motor neuropathy Origin Autoimmune process
Item
motor neuropathy of autoimmune origin
boolean
C0235025 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0443146 (UMLS CUI [1,3])
Paraneoplastic Syndromes Relationship Small cell carcinoma of lung
Item
sclc-related paraneoplastic syndromes
boolean
C0030472 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0149925 (UMLS CUI [1,3])
Cancer Other | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of female breast | Exception Systemic therapy Prostate carcinoma
Item
any concurrent malignancy other than nonmelanoma skin cancer; carcinoma in situ of the cervix or breast; or prostate cancer treated with systemic therapy (participants with a previous malignancy but without evidence of disease for 5 years were allowed to enter the study)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0686288 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1515119 (UMLS CUI [5,2])
C0600139 (UMLS CUI [5,3])
Systemic therapy Carcinoma of lung | Prior radiation therapy allowed | Operative Surgical Procedures Locoregional Previous allowed
Item
prior systemic therapy for lung cancer. prior radiation therapy or locoregional surgeries performed later than at least 3 weeks prior to randomization date were allowed.
boolean
C1515119 (UMLS CUI [1,1])
C0684249 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C1947913 (UMLS CUI [3,2])
C0205156 (UMLS CUI [3,3])
C0683607 (UMLS CUI [3,4])
Peripheral motor neuropathy CTCAE Grades | Sensory neuropathy CTCAE Grades
Item
grade 2 peripheral neuropathy (motor or sensory)
boolean
C0235025 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0151313 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
HIV Infection | Hepatitis B | Hepatitis C
Item
known hiv or hepatitis b or c infection
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Immunosuppressive Agents chronic | CORTICOSTEROIDS FOR SYSTEMIC USE | Exception Paclitaxel Infusion | Exception Adverse event Relationship Immune system | Exception Adrenal Insufficiency Adverse Event
Item
chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or noncancer-related illnesses). however, use of corticosteroids was allowed if used as premedication for paclitaxel infusion or for treating immune-related adverse events or adrenal insufficiencies.
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C3653708 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0144576 (UMLS CUI [3,2])
C0574032 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0877248 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
C0020962 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C1963059 (UMLS CUI [5,2])
Hematologic function Inadequate | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
inadequate hematologic function defined by an absolute neutrophil count <1,500/mm^3, a platelet count <100,000/mm^3, or hemoglobin level <9 g/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 function Inadequate | Elevated total bilirubin | Relationship Secondary malignant neoplasm of liver | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
inadequate hepatic function defined by a total bilirubin level >2.0 times the upper limit of normal (uln), or ≥2.5 times the uln if liver metastases are present, aspartate aminotransferase and alanine aminotransferase levels ≥2.5 times the uln or
boolean
C0232741 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0741494 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C0494165 (UMLS CUI [3,2])
C0151904 (UMLS CUI [4])
C0151905 (UMLS CUI [5])
Aspartate aminotransferase increased | Alanine aminotransferase increased | Relationship Secondary malignant neoplasm of liver
Item
≥5 times the uln if liver metastases are present.
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C0494165 (UMLS CUI [3,2])
Renal function Inadequate | Serum creatinine raised
Item
inadequate renal function defined by a serum creatinine level ≥2.5 times the uln
boolean
C0232804 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0700225 (UMLS CUI [2])
Creatinine clearance Inadequate
Item
inadequate creatinine clearance defined as less than 50 ml/min.
boolean
C0812399 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
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