ID

28318

Descrição

A Study to Assess the Efficacy and Safety of Lenalidomide in Combination With Cetuximab in Pre-treated Patients With KRAS Mutant Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01032291

Link

https://clinicaltrials.gov/show/NCT01032291

Palavras-chave

Versões (1)
  1. 03/01/2018 03/01/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

3 de janeiro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT01032291

Inglês

Eligibility Colorectal Cancer NCT01032291

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. metastatic colorectal adenocarcinoma.
Descrição

Adenocarcinoma of large intestine metastatic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1319315
UMLS CUI [1,2]
C1522484
2. confirmed k-ras mutant tumor
Descrição

KRAS mutation Tumor

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2747837
UMLS CUI [1,2]
C0027651
3. disease progression on oxaliplatin- and irinotecan-containing regimens, with at least one of these regimens containing bevacizumab.
Descrição

Disease Progression | oxaliplatin | irinotecan | bevacizumab

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0069717
UMLS CUI [3]
C0123931
UMLS CUI [4]
C0796392
4. eastern cooperative oncology group (ecog) performance status of ≤ 1.
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. use of chemotherapy, hormonal therapy, immunotherapy or any other cancer or experimental treatment ≤ 28 days prior to the first day of the first cycle.
Descrição

Chemotherapy | Hormone Therapy | Immunotherapy | Cancer treatment | Therapy, Investigational

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0279025
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0920425
UMLS CUI [5]
C0949266
2. radiotherapy for up to ≥ 30% of the bone marrow.
Descrição

Therapeutic radiology procedure Bone Marrow Percentage

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
3. surgery ≤ 28 days before day 1 of the first cycle (minimally invasive interventions for diagnostic purposes or disease staging are permitted).
Descrição

Operative Surgical Procedures | Permission Minimally Invasive Surgical Procedure Diagnostic procedure | Permission Minimally Invasive Surgical Procedures Staging of disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2,1]
C0521104
UMLS CUI [2,2]
C0282624
UMLS CUI [2,3]
C0430022
UMLS CUI [3,1]
C0521104
UMLS CUI [3,2]
C0282624
UMLS CUI [3,3]
C0449385
4. previous treatment with cetuximab, panitumumab, pomalidomide (cc-4047), lenalidomide or thalidomide.
Descrição

cetuximab | panitumumab | pomalidomide | CC-4047 | lenalidomide | Thalidomide

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0995188
UMLS CUI [2]
C0879427
UMLS CUI [3]
C2347624
UMLS CUI [4]
C1176324
UMLS CUI [5]
C1144149
UMLS CUI [6]
C0039736
5. untreated, symptomatic brain metastases (brain imaging not required).
Descrição

Metastatic malignant neoplasm to brain Symptomatic Untreated | Imaging of brain Redundant

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0332155
UMLS CUI [2,1]
C0203860
UMLS CUI [2,2]
C1313915
6. venous thromboembolism ≤ 6 months before day1 of the first cycle.
Descrição

Venous Thromboembolism

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1861172
7. current congestive heart failure (classes ii to iv of the new york heart association).
Descrição

Congestive heart failure New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
8. myocardial infarction ≤ 12 months before day1 of the first cycle.
Descrição

Myocardial Infarction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
9. uncontrolled hypertension.
Descrição

Uncontrolled hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1868885
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Similar models

Eligibility Colorectal Cancer NCT01032291

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of large intestine metastatic
Item
1. metastatic colorectal adenocarcinoma.
boolean
C1319315 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
KRAS mutation Tumor
Item
2. confirmed k-ras mutant tumor
boolean
C2747837 (UMLS CUI [1,1])
C0027651 (UMLS CUI [1,2])
Disease Progression | oxaliplatin | irinotecan | bevacizumab
Item
3. disease progression on oxaliplatin- and irinotecan-containing regimens, with at least one of these regimens containing bevacizumab.
boolean
C0242656 (UMLS CUI [1])
C0069717 (UMLS CUI [2])
C0123931 (UMLS CUI [3])
C0796392 (UMLS CUI [4])
ECOG performance status
Item
4. eastern cooperative oncology group (ecog) performance status of ≤ 1.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Hormone Therapy | Immunotherapy | Cancer treatment | Therapy, Investigational
Item
1. use of chemotherapy, hormonal therapy, immunotherapy or any other cancer or experimental treatment ≤ 28 days prior to the first day of the first cycle.
boolean
C0392920 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0920425 (UMLS CUI [4])
C0949266 (UMLS CUI [5])
Therapeutic radiology procedure Bone Marrow Percentage
Item
2. radiotherapy for up to ≥ 30% of the bone marrow.
boolean
C1522449 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Operative Surgical Procedures | Permission Minimally Invasive Surgical Procedure Diagnostic procedure | Permission Minimally Invasive Surgical Procedures Staging of disease
Item
3. surgery ≤ 28 days before day 1 of the first cycle (minimally invasive interventions for diagnostic purposes or disease staging are permitted).
boolean
C0543467 (UMLS CUI [1])
C0521104 (UMLS CUI [2,1])
C0282624 (UMLS CUI [2,2])
C0430022 (UMLS CUI [2,3])
C0521104 (UMLS CUI [3,1])
C0282624 (UMLS CUI [3,2])
C0449385 (UMLS CUI [3,3])
cetuximab | panitumumab | pomalidomide | CC-4047 | lenalidomide | Thalidomide
Item
4. previous treatment with cetuximab, panitumumab, pomalidomide (cc-4047), lenalidomide or thalidomide.
boolean
C0995188 (UMLS CUI [1])
C0879427 (UMLS CUI [2])
C2347624 (UMLS CUI [3])
C1176324 (UMLS CUI [4])
C1144149 (UMLS CUI [5])
C0039736 (UMLS CUI [6])
Metastatic malignant neoplasm to brain Symptomatic Untreated | Imaging of brain Redundant
Item
5. untreated, symptomatic brain metastases (brain imaging not required).
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C0203860 (UMLS CUI [2,1])
C1313915 (UMLS CUI [2,2])
Venous Thromboembolism
Item
6. venous thromboembolism ≤ 6 months before day1 of the first cycle.
boolean
C1861172 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification
Item
7. current congestive heart failure (classes ii to iv of the new york heart association).
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Myocardial Infarction
Item
8. myocardial infarction ≤ 12 months before day1 of the first cycle.
boolean
C0027051 (UMLS CUI [1])
Uncontrolled hypertension
Item
9. uncontrolled hypertension.
boolean
C1868885 (UMLS CUI [1])
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