ID

40431

Description

A Phase I/II Study of Nab-Paclitaxel, or Paclitaxel, Plus Carboplatin With Concurrent Radiation Therapy Followed by Consolidation in Patients With Favorable Prognosis Inoperable Stage IIIA/B NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT01757288

Link

https://clinicaltrials.gov/show/NCT01757288

Keywords

Versions (1)
  1. 4/20/20 4/20/20 -
Copyright Holder

See clinicaltrials.gov

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April 20, 2020

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Creative Commons BY 4.0
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Eligibility INOPERABLE STAGE IIIA/B NON-SMALL CELL LUNG CANCER NCT01757288

English

Eligibility INOPERABLE STAGE IIIA/B NON-SMALL CELL LUNG CANCER NCT01757288

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically documented nsclc; patients must be m0. patients with t1-t2 with n2 or t3n1-2 are eligible, if inoperable. patients with t4 with any n or any t with n2 or n3 disease are eligible if unresectable.
Description

Non-Small Cell Lung Carcinoma TNM clinical staging | Non-Small Cell Lung Carcinoma Inoperable TNM clinical staging | Non-Small Cell Lung Carcinoma unresectable TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0205187
UMLS CUI [2,3]
C3258246
UMLS CUI [3,1]
C0007131
UMLS CUI [3,2]
C1519810
UMLS CUI [3,3]
C3258246
patients with tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field. the boost volume must be limited to < 50% of the ipsilateral lung volume.
Description

Neoplasms Adjacent Body of vertebra | Boost radiation therapy Disease Gross

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0205117
UMLS CUI [1,3]
C0223084
UMLS CUI [2,1]
C2919491
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0439806
patients with zubrod performance status 0-1
Description

Zubrod Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C3714786
adequate hematologic function
Description

Hematologic function

Data type

boolean

Alias
UMLS CUI [1]
C0221130
fev1 with ≥ 1200 cc or ≥ 50% predicted
Description

FEV1 | Percent predicted FEV1

Data type

boolean

Alias
UMLS CUI [1]
C0849974
UMLS CUI [2]
C0730561
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior systemic chemotherapy (for lung cancer) and/or thoracic/neck radiotherapy for any reason and/or surgical resection of present cancer
Description

Systemic Chemotherapy Malignant neoplasm of lung | Radiotherapy to thorax | Radiotherapy to neck | Excision Malignant Neoplasm Present

Data type

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C0242379
UMLS CUI [2]
C4038705
UMLS CUI [3]
C1997944
UMLS CUI [4,1]
C0728940
UMLS CUI [4,2]
C0006826
UMLS CUI [4,3]
C0150312
exudative, bloody, or cytologically malignant effusions
Description

Exudative pleural effusion | Effusion pleural bloody | Pleural Effusion, Malignant

Data type

boolean

Alias
UMLS CUI [1]
C3887491
UMLS CUI [2]
C0240784
UMLS CUI [3]
C0080032
prior therapy with any molecular targeted drugs (for lung cancer)
Description

Molecular Targeted Therapy Malignant neoplasm of lung

Data type

boolean

Alias
UMLS CUI [1,1]
C2699893
UMLS CUI [1,2]
C0242379
active pulmonary infection not responsive to conventional antibiotics
Description

Infectious disease of lung Unresponsive to Antibiotics

Data type

boolean

Alias
UMLS CUI [1,1]
C0876973
UMLS CUI [1,2]
C0205269
UMLS CUI [1,3]
C0003232
clinically significant cardiovascular event (e.g. myocardial infarction, superior vena cava syndrome (svc), new york heart association (nyha) classification of heart disease >2 (see appendix b) within 3 months before entry; or presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia.
Description

Cardiovascular event | Myocardial Infarction | Superior Vena Cava Syndrome | Heart Disease New York Heart Association Classification | Heart Disease At risk Ventricular arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C1320716
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0038833
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C1275491
UMLS CUI [5,1]
C0018799
UMLS CUI [5,2]
C1444641
UMLS CUI [5,3]
C0085612
patients with > grade 1 neuropathy
Description

Neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
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Similar models

Eligibility INOPERABLE STAGE IIIA/B NON-SMALL CELL LUNG CANCER NCT01757288

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging | Non-Small Cell Lung Carcinoma Inoperable TNM clinical staging | Non-Small Cell Lung Carcinoma unresectable TNM clinical staging
Item
histologically or cytologically documented nsclc; patients must be m0. patients with t1-t2 with n2 or t3n1-2 are eligible, if inoperable. patients with t4 with any n or any t with n2 or n3 disease are eligible if unresectable.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C0205187 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C0007131 (UMLS CUI [3,1])
C1519810 (UMLS CUI [3,2])
C3258246 (UMLS CUI [3,3])
Neoplasms Adjacent Body of vertebra | Boost radiation therapy Disease Gross
Item
patients with tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field. the boost volume must be limited to < 50% of the ipsilateral lung volume.
boolean
C0027651 (UMLS CUI [1,1])
C0205117 (UMLS CUI [1,2])
C0223084 (UMLS CUI [1,3])
C2919491 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0439806 (UMLS CUI [2,3])
Zubrod Performance Status
Item
patients with zubrod performance status 0-1
boolean
C3714786 (UMLS CUI [1])
Hematologic function
Item
adequate hematologic function
boolean
C0221130 (UMLS CUI [1])
FEV1 | Percent predicted FEV1
Item
fev1 with ≥ 1200 cc or ≥ 50% predicted
boolean
C0849974 (UMLS CUI [1])
C0730561 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Systemic Chemotherapy Malignant neoplasm of lung | Radiotherapy to thorax | Radiotherapy to neck | Excision Malignant Neoplasm Present
Item
prior systemic chemotherapy (for lung cancer) and/or thoracic/neck radiotherapy for any reason and/or surgical resection of present cancer
boolean
C1883256 (UMLS CUI [1,1])
C0242379 (UMLS CUI [1,2])
C4038705 (UMLS CUI [2])
C1997944 (UMLS CUI [3])
C0728940 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
C0150312 (UMLS CUI [4,3])
Exudative pleural effusion | Effusion pleural bloody | Pleural Effusion, Malignant
Item
exudative, bloody, or cytologically malignant effusions
boolean
C3887491 (UMLS CUI [1])
C0240784 (UMLS CUI [2])
C0080032 (UMLS CUI [3])
Molecular Targeted Therapy Malignant neoplasm of lung
Item
prior therapy with any molecular targeted drugs (for lung cancer)
boolean
C2699893 (UMLS CUI [1,1])
C0242379 (UMLS CUI [1,2])
Infectious disease of lung Unresponsive to Antibiotics
Item
active pulmonary infection not responsive to conventional antibiotics
boolean
C0876973 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
Cardiovascular event | Myocardial Infarction | Superior Vena Cava Syndrome | Heart Disease New York Heart Association Classification | Heart Disease At risk Ventricular arrhythmia
Item
clinically significant cardiovascular event (e.g. myocardial infarction, superior vena cava syndrome (svc), new york heart association (nyha) classification of heart disease >2 (see appendix b) within 3 months before entry; or presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia.
boolean
C1320716 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0038833 (UMLS CUI [3])
C0018799 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C0018799 (UMLS CUI [5,1])
C1444641 (UMLS CUI [5,2])
C0085612 (UMLS CUI [5,3])
Neuropathy CTCAE Grades
Item
patients with > grade 1 neuropathy
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
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