ID

29322

Description

The Role of Positron Emission Tomography (PET) During Erlotinib Treatment for Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01000428

Link

https://clinicaltrials.gov/show/NCT01000428

Keywords

Versions (1)
  1. 3/18/18 3/18/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 18, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Erlotinib NCT01000428

English

Eligibility Erlotinib NCT01000428

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Erlotinib NCT01000428
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
> 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
histologically documented non-small cell lung cancer with metastasis (stage iv) or locally advanced (stage iiib) with malignant effusion.
Description

Non-small cell lung cancer metastatic TNM clinical staging | Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Effusion, Malignant

Data type

boolean

Alias
UMLS CUI [1,1]
C0278987
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0205179
UMLS CUI [2,3]
C1517927
UMLS CUI [2,4]
C3258246
UMLS CUI [3]
C0080032
at least 1 measurable lesion as defined by recist. all target lesions must have a unidirectional diameter of at least 1cm. baseline measurements must be compared within 4 weeks prior to enrollment.
Description

Measurable Disease Quantity | Target Lesion Diameter Size

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C2986546
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0456389
ecog ps 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
at least 3 weeks since the 1st line systemic therapy regimen prior to enrollment. patients must have recovered to nci ctcae v3.0 grade i from all toxicities. but 1st line erlotinib treatment is also allowed.
Description

Systemic therapy First line | Toxicity CTCAE Grades Patient recovered | Erlotinib First line treatment allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C1708063
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C1516728
UMLS CUI [2,3]
C1115804
UMLS CUI [3,1]
C1135135
UMLS CUI [3,2]
C1708063
UMLS CUI [3,3]
C0683607
at least 1 week since the last radiotherapy. patients must have recovered from all acute toxicities from radiotherapy.
Description

Therapeutic radiology procedure | Toxicity Patient recovered

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C1115804
patients must have adequate hematologic, renal and liver function as defined by hb > 9g/dl, neutrophils > 1000/mm3, platelets > 50,000/mm3, creatinine < 2mg/dl, and ast (sgot) and/or alt (sgpt) < 5 x unl (upper normal limit).
Description

Hematologic function | Renal function | Liver function | Hemoglobin measurement | Neutrophil count | Platelet Count measurement | Creatinine measurement, serum | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C0518015
UMLS CUI [5]
C0200633
UMLS CUI [6]
C0032181
UMLS CUI [7]
C0201976
UMLS CUI [8]
C0201899
UMLS CUI [9]
C0201836
willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
written and voluntary informed consent understood, signed and dated.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior egfr tki treatment.
Description

EGFR TKI Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0034802
UMLS CUI [1,2]
C1268567
UMLS CUI [1,3]
C0087111
symptomatic brain metastasis. brain metastases stable < 2 weeks before dosing or requiring concurrent steroid treatment or with clinical symptoms.
Description

Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Stable | Steroid therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0205360
UMLS CUI [3]
C0149783
major surgery within 3 weeks prior to study enrollment.
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
previous (less than 3 years ago) or current malignancies at sites other than curatively treated in situ carcinoma of cervix, or basal or squamous cell carcinoma of the skin.
Description

Malignant Neoplasms | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin

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]
C1273390
UMLS CUI [3,3]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0553723
severe medical illness or active infection that would impair the ability to receive erlotinib.
Description

Severe disorder Impairment Receive Erlotinib | Communicable Disease Impairment Receive Erlotinib

Data type

boolean

Alias
UMLS CUI [1,1]
C1836348
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C1514756
UMLS CUI [1,4]
C1135135
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C1514756
UMLS CUI [2,4]
C1135135
pregnancy or breast feeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Erlotinib NCT01000428

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Erlotinib NCT01000428
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
> 18 years of age
boolean
C0001779 (UMLS CUI [1])
Non-small cell lung cancer metastatic TNM clinical staging | Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging | Effusion, Malignant
Item
histologically documented non-small cell lung cancer with metastasis (stage iv) or locally advanced (stage iiib) with malignant effusion.
boolean
C0278987 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C1517927 (UMLS CUI [2,3])
C3258246 (UMLS CUI [2,4])
C0080032 (UMLS CUI [3])
Measurable Disease Quantity | Target Lesion Diameter Size
Item
at least 1 measurable lesion as defined by recist. all target lesions must have a unidirectional diameter of at least 1cm. baseline measurements must be compared within 4 weeks prior to enrollment.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2986546 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0456389 (UMLS CUI [2,3])
ECOG performance status
Item
ecog ps 0-2
boolean
C1520224 (UMLS CUI [1])
Systemic therapy First line | Toxicity CTCAE Grades Patient recovered | Erlotinib First line treatment allowed
Item
at least 3 weeks since the 1st line systemic therapy regimen prior to enrollment. patients must have recovered to nci ctcae v3.0 grade i from all toxicities. but 1st line erlotinib treatment is also allowed.
boolean
C1515119 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
C1115804 (UMLS CUI [2,3])
C1135135 (UMLS CUI [3,1])
C1708063 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
Therapeutic radiology procedure | Toxicity Patient recovered
Item
at least 1 week since the last radiotherapy. patients must have recovered from all acute toxicities from radiotherapy.
boolean
C1522449 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C1115804 (UMLS CUI [2,2])
Hematologic function | Renal function | Liver function | Hemoglobin measurement | Neutrophil count | Platelet Count measurement | Creatinine measurement, serum | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
patients must have adequate hematologic, renal and liver function as defined by hb > 9g/dl, neutrophils > 1000/mm3, platelets > 50,000/mm3, creatinine < 2mg/dl, and ast (sgot) and/or alt (sgpt) < 5 x unl (upper normal limit).
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0200633 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
C0201899 (UMLS CUI [8])
C0201836 (UMLS CUI [9])
Protocol Compliance
Item
willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
written and voluntary informed consent understood, signed and dated.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
EGFR TKI Therapeutic procedure
Item
prior egfr tki treatment.
boolean
C0034802 (UMLS CUI [1,1])
C1268567 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Stable | Steroid therapy
Item
symptomatic brain metastasis. brain metastases stable < 2 weeks before dosing or requiring concurrent steroid treatment or with clinical symptoms.
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0149783 (UMLS CUI [3])
Major surgery
Item
major surgery within 3 weeks prior to study enrollment.
boolean
C0679637 (UMLS CUI [1])
Malignant Neoplasms | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin
Item
previous (less than 3 years ago) or current malignancies at sites other than curatively treated in situ carcinoma of cervix, or basal or squamous cell carcinoma of the skin.
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])
C1273390 (UMLS CUI [3,2])
C0007117 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0553723 (UMLS CUI [4,3])
Severe disorder Impairment Receive Erlotinib | Communicable Disease Impairment Receive Erlotinib
Item
severe medical illness or active infection that would impair the ability to receive erlotinib.
boolean
C1836348 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
C1135135 (UMLS CUI [1,4])
C0009450 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C1514756 (UMLS CUI [2,3])
C1135135 (UMLS CUI [2,4])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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