ID

17935

Beschreibung

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

Stichworte

Versionen (1)
  1. 10.10.16 10.10.16 -
Hochgeladen am

10. Oktober 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00238615

Englisch

Eligibility Lung Cancer NCT00238615

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Non-Small Cell Lung Carcinoma | TNM clinical staging

Datentyp

boolean

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

Measurable Disease

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

Age

Datentyp

boolean

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

Life Expectancy

Datentyp

boolean

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

ECOG performance status

Datentyp

boolean

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

organ function | Bone Marrow function

Datentyp

boolean

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

Medically fit for surgery

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

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

Datentyp

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.
Beschreibung

Investigational New Drugs

Datentyp

boolean

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

Neoplasm Metastasis | Metastatic malignant neoplasm to brain

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Peripheral Neuropathy | CTCAE Grades

Datentyp

boolean

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

Comorbidity Uncontrolled

Datentyp

boolean

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

Pregnancy

Datentyp

boolean

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

Weight decreased Percentage

Datentyp

boolean

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

Hyperglycemia | Positron-Emission Tomography Exclusion of

Datentyp

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.
Beschreibung

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

Datentyp

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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Ähnliche Modelle

Eligibility Lung Cancer NCT00238615

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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