ID

36285

Description

A Study Comparing Chemotherapy Dosing Based on Either Standard Body Surface Area or Lean Body Mass in Patients With Advanced Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01624051

Link

https://clinicaltrials.gov/show/NCT01624051

Keywords

Versions (1)
  1. 4/29/19 4/29/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 29, 2019

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License

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT01624051

English

Eligibility Lung Cancer NCT01624051

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
recommendation from treating oncologist to receive a cisplatin based chemotherapy regimen, specifically either cisplatin/vinorelbine or cisplatin/gemcitabine
Description

Chemotherapy Regimen Cisplatin Based | cisplatin/vinorelbine | cisplatin/gemcitabine

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0008838
UMLS CUI [1,3]
C1705938
UMLS CUI [2]
C0281497
UMLS CUI [3]
C0338265
> or = 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
histologically proven diagnosis of non-small cell lung cancer, stage iiib or iv
Description

Non-Small Cell Lung Carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
adequate renal function: creatinine < 1.5 mg/dl or < 132 µmol/l and creatinine clearance of > 45 ml/min using the cockcroft-gault formula
Description

Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C2711451
adequate hepatic function: bilirubin < 1.5 mg/dl or < 25 µmol/l and ast and alt < 2 times upper limit of normal, unless there is evidence of liver metastases, in which case < 5 times upper limit of normal
Description

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Exception Secondary malignant neoplasm of liver

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0494165
adequate hematological function: absolute neutrophil count (anc) > 1.5 x 109/l and platelets > 100 x 109/l and hemoglobin > 100 g/l
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
eastern cooperative oncology group (ecog) performance status of 0 - 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
negative serum pregnancy test for women of childbearing potential. women and men of child bearing potential must use effective contraception defined as the simultaneous use of two reliable methods unless abstinence is the chosen method.
Description

Childbearing Potential Serum pregnancy test negative | Females & males of reproductive potential Contraceptive methods Quantity | Exception Sexual Abstinence

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C4034483
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0036899
life expectancy of > 4 months in the opinion of the treating oncologist
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
prior radiotherapy is allowed (unless > 25% of bone marrow stores) if this radiation was > 4 weeks before study entry and patient has fully recovered from toxicity of this treatment
Description

Prior radiation therapy | Exception Bone Marrow Percentage | Toxicity Due to Prior radiation therapy | Patient recovered

Data type

boolean

Alias
UMLS CUI [1]
C0279134
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0005953
UMLS CUI [2,3]
C0439165
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0279134
UMLS CUI [4]
C1115804
willingness to comply with the study protocol
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
ability to give written informed consent with the understanding that it may be withdrawn at any time without prejudice
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
brain metastases (a ct or mri is not required to rule out brain metastases unless there is clinical suspicion)
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
previous or concurrent malignancies, excluding curatively treated in situ carcinoma of the cervix, in situ ductal breast cancer, non-melanoma skin cancer or low grade bladder cancer
Description

Malignant Neoplasms | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Ductal Carcinoma in Situ of Breast | Exception Skin carcinoma | Exception Carcinoma of bladder low grade

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007124
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0699893
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0699885
UMLS CUI [5,3]
C1282907
patients who have had major surgery within three weeks of enrollment without a full recovery
Description

Major surgery | Recovery Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C2004454
UMLS CUI [2,2]
C0332268
prior treatment with any anticancer therapy
Description

Cancer treatment Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
patients who have tested positive for hiv
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
any significant medical or psychiatric condition that, in the opinion of the investigator, will exclude the patient from the study for compliance or safety reasons
Description

Medical condition Study Subject Participation Status Excluded | Mental condition Study Subject Participation Status Excluded | Compliance behavior Limited | Patient safety At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332196
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0439801
UMLS CUI [4,1]
C1113679
UMLS CUI [4,2]
C1444641
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Similar models

Eligibility Lung Cancer NCT01624051

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chemotherapy Regimen Cisplatin Based | cisplatin/vinorelbine | cisplatin/gemcitabine
Item
recommendation from treating oncologist to receive a cisplatin based chemotherapy regimen, specifically either cisplatin/vinorelbine or cisplatin/gemcitabine
boolean
C0392920 (UMLS CUI [1,1])
C0008838 (UMLS CUI [1,2])
C1705938 (UMLS CUI [1,3])
C0281497 (UMLS CUI [2])
C0338265 (UMLS CUI [3])
Age
Item
> or = 18 years of age
boolean
C0001779 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
histologically proven diagnosis of non-small cell lung cancer, stage iiib or iv
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
adequate renal function: creatinine < 1.5 mg/dl or < 132 µmol/l and creatinine clearance of > 45 ml/min using the cockcroft-gault formula
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Exception Secondary malignant neoplasm of liver
Item
adequate hepatic function: bilirubin < 1.5 mg/dl or < 25 µmol/l and ast and alt < 2 times upper limit of normal, unless there is evidence of liver metastases, in which case < 5 times upper limit of normal
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0494165 (UMLS CUI [5,2])
Hematologic function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
adequate hematological function: absolute neutrophil count (anc) > 1.5 x 109/l and platelets > 100 x 109/l and hemoglobin > 100 g/l
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 - 2
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative | Females & males of reproductive potential Contraceptive methods Quantity | Exception Sexual Abstinence
Item
negative serum pregnancy test for women of childbearing potential. women and men of child bearing potential must use effective contraception defined as the simultaneous use of two reliable methods unless abstinence is the chosen method.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C4034483 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
Life Expectancy
Item
life expectancy of > 4 months in the opinion of the treating oncologist
boolean
C0023671 (UMLS CUI [1])
Prior radiation therapy | Exception Bone Marrow Percentage | Toxicity Due to Prior radiation therapy | Patient recovered
Item
prior radiotherapy is allowed (unless > 25% of bone marrow stores) if this radiation was > 4 weeks before study entry and patient has fully recovered from toxicity of this treatment
boolean
C0279134 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0005953 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C0600688 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0279134 (UMLS CUI [3,3])
C1115804 (UMLS CUI [4])
Protocol Compliance
Item
willingness to comply with the study protocol
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
ability to give written informed consent with the understanding that it may be withdrawn at any time without prejudice
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Metastatic malignant neoplasm to brain
Item
brain metastases (a ct or mri is not required to rule out brain metastases unless there is clinical suspicion)
boolean
C0220650 (UMLS CUI [1])
Malignant Neoplasms | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Ductal Carcinoma in Situ of Breast | Exception Skin carcinoma | Exception Carcinoma of bladder low grade
Item
previous or concurrent malignancies, excluding curatively treated in situ carcinoma of the cervix, in situ ductal breast cancer, non-melanoma skin cancer or low grade bladder cancer
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0851140 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007124 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0699893 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0699885 (UMLS CUI [5,2])
C1282907 (UMLS CUI [5,3])
Major surgery | Recovery Lacking
Item
patients who have had major surgery within three weeks of enrollment without a full recovery
boolean
C0679637 (UMLS CUI [1])
C2004454 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Cancer treatment Previous
Item
prior treatment with any anticancer therapy
boolean
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
HIV Seropositivity
Item
patients who have tested positive for hiv
boolean
C0019699 (UMLS CUI [1])
Medical condition Study Subject Participation Status Excluded | Mental condition Study Subject Participation Status Excluded | Compliance behavior Limited | Patient safety At risk
Item
any significant medical or psychiatric condition that, in the opinion of the investigator, will exclude the patient from the study for compliance or safety reasons
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C1321605 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C1113679 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
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