ID

21331

Descrição

A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Advanced Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00801294

Link

https://clinicaltrials.gov/show/NCT00801294

Palavras-chave

Versões (1)
  1. 17/04/2017 17/04/2017 -
Transferido a

17 de abril de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Colorectal Neoplasms NCT00801294

Inglês

Eligibility Colorectal Neoplasms NCT00801294

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age over 18 years.
Descrição

age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
2. signed informed consent.
Descrição

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
3. histologically proven colorectal adenocarcinoma
Descrição

colorectal adenocarcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1319315
4. history or presence of metastatic colorectal cancer (stage iv)
Descrição

colorectal cancer stage IV

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0677950
5. measurable (>1 cm) or evaluable tumour deposit (according to recist criteria)
Descrição

measurable tumor

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1302351
6. documented progression or unacceptable toxicity on the last therapy
Descrição

tumor progression or toxicity on therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0178874
UMLS CUI [1,2]
C0087111
UMLS CUI [2,1]
C0013221
UMLS CUI [2,2]
C0087111
7. progression on oxaliplatin-based chemotherapy or unacceptable residual neurotoxicity on oxaliplatin
Descrição

tumor progression or neurotoxicity on oxliplatin

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0069717
UMLS CUI [1,2]
C0178874
UMLS CUI [2,1]
C0069717
UMLS CUI [2,2]
C0235032
8. progression on irinotecan-based chemotherapy or unacceptable toxicity on irinotecan
Descrição

tumor progression or toxicity on irinotecan

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0123931
UMLS CUI [1,2]
C0178874
UMLS CUI [2,1]
C0123931
UMLS CUI [2,2]
C0013221
9. if patients have been previously exposed to cetuximab or other egfr inhibitor, they must have shown progression or unacceptable toxicity
Descrição

tumor progression or toxicity on egfr inhibitor

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1443775
UMLS CUI [1,2]
C0178874
UMLS CUI [2,1]
C1443775
UMLS CUI [2,2]
C0013221
10. if patients have been previously exposed to bevacizumab or other vegf inhibitor, they must have shown progression or unacceptable toxicity
Descrição

tumor progression or toxicity on bevacizumab

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0796392
UMLS CUI [1,2]
C0178874
UMLS CUI [2,1]
C0796392
UMLS CUI [2,2]
C0013221
11. life expectancy of at least 12 weeks.
Descrição

life expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
12. who (ecog) performance status <= 2, <= 1 if age > 75 years.
Descrição

ecog performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
13. adequate hepatic function
Descrição

hepatic function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232741
14. adequate renal function
Descrição

renal function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232804
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior treatment with small molecule egfr, her2 or vegfr tyrosine kinase inhibitors
Descrição

egfr, her2 or vegfr tyrosine kinase inhibitors

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1443775
UMLS CUI [2]
C1268567
UMLS CUI [3]
C2985521
2. treatment with standard chemotherapy or cetuximab within the last 14 days
Descrição

chemotherapy, cetuximab

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0995188
3. treatment with bevacizumab within the last 28 days
Descrição

bevacizumab

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0796392
4. history of other malignancies in the last 5 years, which could affect compliance with the protocol or interpretation of results. patients with adequately treated basal or squamous cell skin cancer are generally eligible.
Descrição

other malignancies affecting compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1321605
5. serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality
Descrição

neurologic, psychiatric, infectious or ulcer comorbidities or laboratory abnormality

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0027765
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0004936
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0009450
UMLS CUI [4,1]
C0009488
UMLS CUI [4,2]
C0041582
UMLS CUI [5]
C0009488
6. significant cardiovascular diseases
Descrição

cardiovascular diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007222
7. history of haemorrhagic or thrombotic event in the past 12 months. known inherited predisposition to bleeds or to thrombosis.
Descrição

haemorrhage or thrombosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C0040053
8. patient with history or clinical or radiological evidence of cns disease or brain metastases.
Descrição

cns disease or brain metastases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2]
C0220650
9. pregnancy or breast-feeding
Descrição

pregnancy, breast feeding

Tipo de dados

boolean

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

Eligibility Colorectal Neoplasms NCT00801294

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
1. age over 18 years.
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
2. signed informed consent.
boolean
C0021430 (UMLS CUI [1])
colorectal adenocarcinoma
Item
3. histologically proven colorectal adenocarcinoma
boolean
C1319315 (UMLS CUI [1])
colorectal cancer stage IV
Item
4. history or presence of metastatic colorectal cancer (stage iv)
boolean
C0677950 (UMLS CUI [1])
measurable tumor
Item
5. measurable (>1 cm) or evaluable tumour deposit (according to recist criteria)
boolean
C1302351 (UMLS CUI [1])
tumor progression or toxicity on therapy
Item
6. documented progression or unacceptable toxicity on the last therapy
boolean
C0178874 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0013221 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
tumor progression or neurotoxicity on oxliplatin
Item
7. progression on oxaliplatin-based chemotherapy or unacceptable residual neurotoxicity on oxaliplatin
boolean
C0069717 (UMLS CUI [1,1])
C0178874 (UMLS CUI [1,2])
C0069717 (UMLS CUI [2,1])
C0235032 (UMLS CUI [2,2])
tumor progression or toxicity on irinotecan
Item
8. progression on irinotecan-based chemotherapy or unacceptable toxicity on irinotecan
boolean
C0123931 (UMLS CUI [1,1])
C0178874 (UMLS CUI [1,2])
C0123931 (UMLS CUI [2,1])
C0013221 (UMLS CUI [2,2])
tumor progression or toxicity on egfr inhibitor
Item
9. if patients have been previously exposed to cetuximab or other egfr inhibitor, they must have shown progression or unacceptable toxicity
boolean
C1443775 (UMLS CUI [1,1])
C0178874 (UMLS CUI [1,2])
C1443775 (UMLS CUI [2,1])
C0013221 (UMLS CUI [2,2])
tumor progression or toxicity on bevacizumab
Item
10. if patients have been previously exposed to bevacizumab or other vegf inhibitor, they must have shown progression or unacceptable toxicity
boolean
C0796392 (UMLS CUI [1,1])
C0178874 (UMLS CUI [1,2])
C0796392 (UMLS CUI [2,1])
C0013221 (UMLS CUI [2,2])
life expectancy
Item
11. life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1])
ecog performance status
Item
12. who (ecog) performance status <= 2, <= 1 if age > 75 years.
boolean
C1520224 (UMLS CUI [1])
hepatic function
Item
13. adequate hepatic function
boolean
C0232741 (UMLS CUI [1])
renal function
Item
14. adequate renal function
boolean
C0232804 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
egfr, her2 or vegfr tyrosine kinase inhibitors
Item
1. prior treatment with small molecule egfr, her2 or vegfr tyrosine kinase inhibitors
boolean
C1443775 (UMLS CUI [1])
C1268567 (UMLS CUI [2])
C2985521 (UMLS CUI [3])
chemotherapy, cetuximab
Item
2. treatment with standard chemotherapy or cetuximab within the last 14 days
boolean
C0392920 (UMLS CUI [1])
C0995188 (UMLS CUI [2])
bevacizumab
Item
3. treatment with bevacizumab within the last 28 days
boolean
C0796392 (UMLS CUI [1])
other malignancies affecting compliance
Item
4. history of other malignancies in the last 5 years, which could affect compliance with the protocol or interpretation of results. patients with adequately treated basal or squamous cell skin cancer are generally eligible.
boolean
C0006826 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
neurologic, psychiatric, infectious or ulcer comorbidities or laboratory abnormality
Item
5. serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality
boolean
C0009488 (UMLS CUI [1,1])
C0027765 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0004936 (UMLS CUI [2,2])
C0009488 (UMLS CUI [3,1])
C0009450 (UMLS CUI [3,2])
C0009488 (UMLS CUI [4,1])
C0041582 (UMLS CUI [4,2])
C0009488 (UMLS CUI [5])
cardiovascular diseases
Item
6. significant cardiovascular diseases
boolean
C0007222 (UMLS CUI [1])
haemorrhage or thrombosis
Item
7. history of haemorrhagic or thrombotic event in the past 12 months. known inherited predisposition to bleeds or to thrombosis.
boolean
C0019080 (UMLS CUI [1])
C0040053 (UMLS CUI [2])
cns disease or brain metastases
Item
8. patient with history or clinical or radiological evidence of cns disease or brain metastases.
boolean
C0007682 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
pregnancy, breast feeding
Item
9. pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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