ID

44020

Descrição

Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00049998

Link

https://clinicaltrials.gov/show/NCT00049998

Palavras-chave

Versões (2)
  1. 25/05/2016 25/05/2016 -
  2. 20/09/2021 20/09/2021 -
Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Non-Small-Cell Lung Cancer NCT00049998

Inglês

Eligibility Non-Small-Cell Lung Cancer NCT00049998

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent
Descrição

written informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
patients with advanced non-small cell lung cancer (nsclc).
Descrição

nsclc

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
patients who have received one previous chemotherapy for nsclc.
Descrição

previous chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392920
full recovery from previous chemotherapy.
Descrição

full recovery from previous chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2004454
UMLS CUI [1,2]
C0392920
presence of either measurable or non-measurable disease by radiologic study or physical examination.
Descrição

comorbidity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
at least 3 weeks since last major surgery (a lesser period is acceptable if deemed in the best interest of the patient).
Descrição

major surgery

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0679637
at least 24 hours since prior radiotherapy providing that marked bone marrow suppression is not expected. patients who have received radiotherapy must have recovered from any reversible side effects (e.g. nausea and vomiting).
Descrição

recovered from any reversible side effects

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2826210
UMLS CUI [1,2]
C0001688
UMLS CUI [1,3]
C1522449
laboratory criteria: patients must have adequate bone marrow reserve and adequate kidney and liver function.
Descrição

adequate bone marrow reserve and adequate kidney and liver function

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0205411
UMLS CUI [2,1]
C0232804
UMLS CUI [2,2]
C0205411
UMLS CUI [3,1]
C0232741
UMLS CUI [3,2]
C0205411
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
symptoms of brain metastasis (cancer spreading to the brain), requiring treatment with steroids.
Descrição

brain metastasis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0220650
active infection.
Descrição

active infection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
severe medical problems other than the diagnosis of nsclc, that would limit the ability of the patient to follow study guidelines or expose the patient to extreme risk.
Descrição

comorbidity limiting study participation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of nsclc.
Descrição

planned therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1301732
use of investigational drug within 30 days prior to the first dose of study medication.
Descrição

participation in another trial

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
women who are pregnant or lactating.
Descrição

pregnant or lactating women

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
patients of child-bearing potential refusing to practice adequate birth control methods.
Descrição

contraceptive use

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1999124
patients with conditions which might alter absorption of an oral drug.
Descrição

conditions which might alter absorption

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0000854
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Similar models

Eligibility Non-Small-Cell Lung Cancer NCT00049998

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
nsclc
Item
patients with advanced non-small cell lung cancer (nsclc).
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
previous chemotherapy
Item
patients who have received one previous chemotherapy for nsclc.
boolean
C0392920 (UMLS CUI [1])
full recovery from previous chemotherapy
Item
full recovery from previous chemotherapy.
boolean
C2004454 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
comorbidity
Item
presence of either measurable or non-measurable disease by radiologic study or physical examination.
boolean
C0009488 (UMLS CUI [1])
major surgery
Item
at least 3 weeks since last major surgery (a lesser period is acceptable if deemed in the best interest of the patient).
boolean
C0679637 (UMLS CUI [1])
recovered from any reversible side effects
Item
at least 24 hours since prior radiotherapy providing that marked bone marrow suppression is not expected. patients who have received radiotherapy must have recovered from any reversible side effects (e.g. nausea and vomiting).
boolean
C2826210 (UMLS CUI [1,1])
C0001688 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,3])
adequate bone marrow reserve and adequate kidney and liver function
Item
laboratory criteria: patients must have adequate bone marrow reserve and adequate kidney and liver function.
boolean
C0005953 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2,1])
C0205411 (UMLS CUI [2,2])
C0232741 (UMLS CUI [3,1])
C0205411 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
brain metastasis
Item
symptoms of brain metastasis (cancer spreading to the brain), requiring treatment with steroids.
boolean
C0220650 (UMLS CUI [1])
active infection
Item
active infection.
boolean
C0009450 (UMLS CUI [1])
comorbidity limiting study participation
Item
severe medical problems other than the diagnosis of nsclc, that would limit the ability of the patient to follow study guidelines or expose the patient to extreme risk.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
planned therapy
Item
ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of nsclc.
boolean
C0087111 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
participation in another trial
Item
use of investigational drug within 30 days prior to the first dose of study medication.
boolean
C2348568 (UMLS CUI [1])
pregnant or lactating women
Item
women who are pregnant or lactating.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
contraceptive use
Item
patients of child-bearing potential refusing to practice adequate birth control methods.
boolean
C1999124 (UMLS CUI [1])
conditions which might alter absorption
Item
patients with conditions which might alter absorption of an oral drug.
boolean
C0087111 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0000854 (UMLS CUI [1,3])
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