ID

30806

Description

A Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Squamous Cell Carcinoma of the Lung; ODM derived from: https://clinicaltrials.gov/show/NCT00998192

Link

https://clinicaltrials.gov/show/NCT00998192

Keywords

Versions (1)
  1. 6/21/18 6/21/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 21, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic or Recurrent Squamous Cell Carcinoma of the Lung NCT00998192

English

Eligibility Metastatic or Recurrent Squamous Cell Carcinoma of the Lung NCT00998192

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have histologically or cytologically confirmed metastatic stage iiib (pleural effusion; iva on revised iaslc staging) or stage iv, or recurrent squamous cell carcinoma of the lung.
Description

Squamous cell carcinoma of lung metastatic TNM clinical staging | Lung squamous cell carcinoma recurrent TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0149782
UMLS CUI [1,2]
C1522484
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C0854989
UMLS CUI [2,2]
C3258246
have measurable disease.
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
be chemotherapy naïve for their metastatic or recurrent scclc, with some exceptions.
Description

Chemotherapy naive Squamous cell carcinoma of lung metastatic | Chemotherapy naive Lung squamous cell carcinoma recurrent | Exception Some

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0919936
UMLS CUI [1,3]
C0149782
UMLS CUI [1,4]
C1522484
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0919936
UMLS CUI [2,3]
C0854989
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0205392
have no continuing acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures.
Description

Toxicity due to radiotherapy Absent | Toxicity due to chemotherapy Absent | Absence Toxicity Due to Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C1302210
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1302255
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0600688
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C0543467
have an ecog performance score of ≤ 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
have a life expectancy of at least 3 months.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
absolute neutrophil count (anc) ≥ 1.5 x 10^9; platelets ≥ 100 x10^9 (without platelet transfusion);hemoglobin ≥ 9.0 g/dl (with or without rbc transfusion); serum creatinine ≤ 1.5 x upper limit of normal (uln); bilirubin ≤ 1.5 x uln; ast/alt ≤ 2.5 x uln.
Description

Absolute neutrophil count | Platelet Count measurement | Platelet Transfusion Absent | Hemoglobin measurement | Red Blood Cell Transfusion | Red Blood Cell Transfusion Absent | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3,1]
C0086818
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0518015
UMLS CUI [5]
C0086252
UMLS CUI [6,1]
C0086252
UMLS CUI [6,2]
C0332197
UMLS CUI [7]
C0201976
UMLS CUI [8]
C1278039
UMLS CUI [9]
C0201899
UMLS CUI [10]
C0201836
negative pregnancy test for females with childbearing potential.
Description

Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
receive concurrent therapy with any other investigational anticancer agent while on study.
Description

Therapies, Investigational | Antineoplastic Agents Investigational

Data type

boolean

Alias
UMLS CUI [1]
C0949266
UMLS CUI [2,1]
C0003392
UMLS CUI [2,2]
C1517586
have a known past or current history of brain metastasis(es).
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
be on immunosuppressive therapy or have known hiv infection or active hepatitis b or c.
Description

Therapeutic immunosuppression | HIV Infection | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019196
be a pregnant or breast-feeding woman.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
have clinically significant cardiac disease.
Description

Heart Disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
have dementia or altered mental status that would prohibit informed consent.
Description

Dementia Preventing Informed Consent | Mental state altered Preventing Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0278060
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C1292733
UMLS CUI [2,4]
C0021430
have any other acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the principal investigator, would make the patient inappropriate for this study.
Description

Medical condition Study Subject Participation Status At risk | Medical condition At risk Investigational New Drugs | Medical condition Interferes with Interpretation Research results | Medical condition Study Subject Participation Status Inappropriate | Mental condition Study Subject Participation Status At risk | Mental condition At risk Investigational New Drugs | Mental condition Interferes with Interpretation Research results | Mental condition Study Subject Participation Status Inappropriate | Laboratory test result abnormal Study Subject Participation Status At risk | Laboratory test result abnormal At risk Investigational New Drugs | Laboratory test result abnormal Interferes with Interpretation Research results | Laboratory test result abnormal Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0459471
UMLS CUI [3,4]
C0683954
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C1548788
UMLS CUI [5,1]
C3840291
UMLS CUI [5,2]
C2348568
UMLS CUI [5,3]
C1444641
UMLS CUI [6,1]
C3840291
UMLS CUI [6,2]
C1444641
UMLS CUI [6,3]
C0013230
UMLS CUI [7,1]
C3840291
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C0459471
UMLS CUI [7,4]
C0683954
UMLS CUI [8,1]
C3840291
UMLS CUI [8,2]
C2348568
UMLS CUI [8,3]
C1548788
UMLS CUI [9,1]
C0438215
UMLS CUI [9,2]
C2348568
UMLS CUI [9,3]
C1444641
UMLS CUI [10,1]
C0438215
UMLS CUI [10,2]
C1444641
UMLS CUI [10,3]
C0013230
UMLS CUI [11,1]
C0438215
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C0459471
UMLS CUI [11,4]
C0683954
UMLS CUI [12,1]
C0438215
UMLS CUI [12,2]
C2348568
UMLS CUI [12,3]
C1548788
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Similar models

Eligibility Metastatic or Recurrent Squamous Cell Carcinoma of the Lung NCT00998192

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of lung metastatic TNM clinical staging | Lung squamous cell carcinoma recurrent TNM clinical staging
Item
have histologically or cytologically confirmed metastatic stage iiib (pleural effusion; iva on revised iaslc staging) or stage iv, or recurrent squamous cell carcinoma of the lung.
boolean
C0149782 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0854989 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Measurable Disease
Item
have measurable disease.
boolean
C1513041 (UMLS CUI [1])
Chemotherapy naive Squamous cell carcinoma of lung metastatic | Chemotherapy naive Lung squamous cell carcinoma recurrent | Exception Some
Item
be chemotherapy naïve for their metastatic or recurrent scclc, with some exceptions.
boolean
C0392920 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0149782 (UMLS CUI [1,3])
C1522484 (UMLS CUI [1,4])
C0392920 (UMLS CUI [2,1])
C0919936 (UMLS CUI [2,2])
C0854989 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0205392 (UMLS CUI [3,2])
Toxicity due to radiotherapy Absent | Toxicity due to chemotherapy Absent | Absence Toxicity Due to Operative Surgical Procedures
Item
have no continuing acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures.
boolean
C1302210 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1302255 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C0600688 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C0543467 (UMLS CUI [3,4])
ECOG performance status
Item
have an ecog performance score of ≤ 2.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
have a life expectancy of at least 3 months.
boolean
C0023671 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement | Platelet Transfusion Absent | Hemoglobin measurement | Red Blood Cell Transfusion | Red Blood Cell Transfusion Absent | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
absolute neutrophil count (anc) ≥ 1.5 x 10^9; platelets ≥ 100 x10^9 (without platelet transfusion);hemoglobin ≥ 9.0 g/dl (with or without rbc transfusion); serum creatinine ≤ 1.5 x upper limit of normal (uln); bilirubin ≤ 1.5 x uln; ast/alt ≤ 2.5 x uln.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0086818 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0518015 (UMLS CUI [4])
C0086252 (UMLS CUI [5])
C0086252 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0201976 (UMLS CUI [7])
C1278039 (UMLS CUI [8])
C0201899 (UMLS CUI [9])
C0201836 (UMLS CUI [10])
Childbearing Potential Pregnancy test negative
Item
negative pregnancy test for females with childbearing potential.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Therapies, Investigational | Antineoplastic Agents Investigational
Item
receive concurrent therapy with any other investigational anticancer agent while on study.
boolean
C0949266 (UMLS CUI [1])
C0003392 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
Metastatic malignant neoplasm to brain
Item
have a known past or current history of brain metastasis(es).
boolean
C0220650 (UMLS CUI [1])
Therapeutic immunosuppression | HIV Infection | Hepatitis B | Hepatitis C
Item
be on immunosuppressive therapy or have known hiv infection or active hepatitis b or c.
boolean
C0021079 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
be a pregnant or breast-feeding woman.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Heart Disease
Item
have clinically significant cardiac disease.
boolean
C0018799 (UMLS CUI [1])
Dementia Preventing Informed Consent | Mental state altered Preventing Informed Consent
Item
have dementia or altered mental status that would prohibit informed consent.
boolean
C0497327 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0278060 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0021430 (UMLS CUI [2,4])
Medical condition Study Subject Participation Status At risk | Medical condition At risk Investigational New Drugs | Medical condition Interferes with Interpretation Research results | Medical condition Study Subject Participation Status Inappropriate | Mental condition Study Subject Participation Status At risk | Mental condition At risk Investigational New Drugs | Mental condition Interferes with Interpretation Research results | Mental condition Study Subject Participation Status Inappropriate | Laboratory test result abnormal Study Subject Participation Status At risk | Laboratory test result abnormal At risk Investigational New Drugs | Laboratory test result abnormal Interferes with Interpretation Research results | Laboratory test result abnormal Study Subject Participation Status Inappropriate
Item
have any other acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the principal investigator, would make the patient inappropriate for this study.
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0459471 (UMLS CUI [3,3])
C0683954 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1548788 (UMLS CUI [4,3])
C3840291 (UMLS CUI [5,1])
C2348568 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C3840291 (UMLS CUI [6,1])
C1444641 (UMLS CUI [6,2])
C0013230 (UMLS CUI [6,3])
C3840291 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0459471 (UMLS CUI [7,3])
C0683954 (UMLS CUI [7,4])
C3840291 (UMLS CUI [8,1])
C2348568 (UMLS CUI [8,2])
C1548788 (UMLS CUI [8,3])
C0438215 (UMLS CUI [9,1])
C2348568 (UMLS CUI [9,2])
C1444641 (UMLS CUI [9,3])
C0438215 (UMLS CUI [10,1])
C1444641 (UMLS CUI [10,2])
C0013230 (UMLS CUI [10,3])
C0438215 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0459471 (UMLS CUI [11,3])
C0683954 (UMLS CUI [11,4])
C0438215 (UMLS CUI [12,1])
C2348568 (UMLS CUI [12,2])
C1548788 (UMLS CUI [12,3])
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