ID

17935

Descripción

Phase II Docetaxel / Carboplatin / XRT + Surgical Resection in Stage III NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT00238615

Link

https://clinicaltrials.gov/show/NCT00238615

Palabras clave

Versiones (1)
  1. 10/10/16 10/10/16 -
Subido en

10 de octubre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00238615

Inglés

Eligibility Lung Cancer NCT00238615

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed stage iiia or iiib nsclc
Descripción

Non-Small Cell Lung Carcinoma | TNM clinical staging

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C3258246
patients must have measurable disease
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
no previous chemotherapy, radiation therapy or other systemic therapy for their nsclc.
Descripción

Prior Chemotherapy Non-Small Cell Lung Carcinoma | prior radiation therapy Non-Small Cell Lung Carcinoma | systemic therapy Non-Small Cell Lung Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0007131
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0007131
UMLS CUI [3,1]
C1515119
UMLS CUI [3,2]
C0007131
age>18 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy >12 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance status 0-1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
normal organ and marrow function
Descripción

organ function | Bone Marrow function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
medically fit for surgery at time of enrollment.
Descripción

Medically fit for surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4075860
women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of the study. women must have a negative pregnancy test prior to enrollment.
Descripción

Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Gender Pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0427780
ability to understand and willingness to sign the consent form.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous chemotherapy, radiation therapy or any other systemic treatment for their nsclc.
Descripción

Prior Chemotherapy Non-Small Cell Lung Carcinoma | prior radiation therapy Non-Small Cell Lung Carcinoma | systemic therapy Non-Small Cell Lung Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0007131
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0007131
UMLS CUI [3,1]
C1515119
UMLS CUI [3,2]
C0007131
patients receiving any other investigational agents.
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
known metastatic disease (brain or any other site)
Descripción

Neoplasm Metastasis | Metastatic malignant neoplasm to brain

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2]
C0220650
history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 or with allergic reactions to compounds of similar chemical composition to carboplatin or other agents used in the study.
Descripción

severe allergy docetaxel | severe allergy Polysorbate 80 | Allergic Reaction Carboplatin | Allergic Reaction Compound Similar | Allergic Reaction Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0246415
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C0032601
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0079083
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C1706082
UMLS CUI [4,3]
C2348205
UMLS CUI [5,1]
C1527304
UMLS CUI [5,2]
C0013230
peripheral neuropathy >grade 1
Descripción

Peripheral Neuropathy | CTCAE Grades

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2]
C1516728
uncontrolled concurrent illness
Descripción

Comorbidity Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
pregnant women
Descripción

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
weight loss>10% in the past 3 months before diagnosis.
Descripción

Weight decreased Percentage

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439165
hyperglycemia - exclusion from pet analysis
Descripción

Hyperglycemia | Positron-Emission Tomography Exclusion of

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020456
UMLS CUI [2,1]
C0032743
UMLS CUI [2,2]
C2828389
hiv positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with docetaxel and carboplatin or other agents administered during the study.
Descripción

HIV Seropositivity | Antiretroviral therapy Combined | Drug Interactions Associated with docetaxel | Drug Interactions Associated with Carboplatin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C1963724
UMLS CUI [2,2]
C0205195
UMLS CUI [3,1]
C0687133
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0246415
UMLS CUI [4,1]
C0687133
UMLS CUI [4,2]
C0332281
UMLS CUI [4,3]
C0079083
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Similar models

Eligibility Lung Cancer NCT00238615

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma | TNM clinical staging
Item
histologically confirmed stage iiia or iiib nsclc
boolean
C0007131 (UMLS CUI [1])
C3258246 (UMLS CUI [2])
Measurable Disease
Item
patients must have measurable disease
boolean
C1513041 (UMLS CUI [1])
Prior Chemotherapy Non-Small Cell Lung Carcinoma | prior radiation therapy Non-Small Cell Lung Carcinoma | systemic therapy Non-Small Cell Lung Carcinoma
Item
no previous chemotherapy, radiation therapy or other systemic therapy for their nsclc.
boolean
C1514457 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
C1515119 (UMLS CUI [3,1])
C0007131 (UMLS CUI [3,2])
Age
Item
age>18 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy >12 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
organ function | Bone Marrow function
Item
normal organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Medically fit for surgery
Item
medically fit for surgery at time of enrollment.
boolean
C4075860 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Gender Pregnancy test negative
Item
women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of the study. women must have a negative pregnancy test prior to enrollment.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
Informed Consent
Item
ability to understand and willingness to sign the consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Non-Small Cell Lung Carcinoma | prior radiation therapy Non-Small Cell Lung Carcinoma | systemic therapy Non-Small Cell Lung Carcinoma
Item
previous chemotherapy, radiation therapy or any other systemic treatment for their nsclc.
boolean
C1514457 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
C1515119 (UMLS CUI [3,1])
C0007131 (UMLS CUI [3,2])
Investigational New Drugs
Item
patients receiving any other investigational agents.
boolean
C0013230 (UMLS CUI [1])
Neoplasm Metastasis | Metastatic malignant neoplasm to brain
Item
known metastatic disease (brain or any other site)
boolean
C0027627 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
severe allergy docetaxel | severe allergy Polysorbate 80 | Allergic Reaction Carboplatin | Allergic Reaction Compound Similar | Allergic Reaction Investigational New Drugs
Item
history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 or with allergic reactions to compounds of similar chemical composition to carboplatin or other agents used in the study.
boolean
C2945656 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2,1])
C0032601 (UMLS CUI [2,2])
C1527304 (UMLS CUI [3,1])
C0079083 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C1706082 (UMLS CUI [4,2])
C2348205 (UMLS CUI [4,3])
C1527304 (UMLS CUI [5,1])
C0013230 (UMLS CUI [5,2])
Peripheral Neuropathy | CTCAE Grades
Item
peripheral neuropathy >grade 1
boolean
C0031117 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
Comorbidity Uncontrolled
Item
uncontrolled concurrent illness
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pregnancy
Item
pregnant women
boolean
C0032961 (UMLS CUI [1])
Weight decreased Percentage
Item
weight loss>10% in the past 3 months before diagnosis.
boolean
C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Hyperglycemia | Positron-Emission Tomography Exclusion of
Item
hyperglycemia - exclusion from pet analysis
boolean
C0020456 (UMLS CUI [1])
C0032743 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
HIV Seropositivity | Antiretroviral therapy Combined | Drug Interactions Associated with docetaxel | Drug Interactions Associated with Carboplatin
Item
hiv positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with docetaxel and carboplatin or other agents administered during the study.
boolean
C0019699 (UMLS CUI [1])
C1963724 (UMLS CUI [2,1])
C0205195 (UMLS CUI [2,2])
C0687133 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0246415 (UMLS CUI [3,3])
C0687133 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C0079083 (UMLS CUI [4,3])
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