ID

28318

Beschreibung

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

Stichworte

Versionen (1)
  1. 03.01.18 03.01.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

3. Januar 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT01032291

Englisch

Eligibility Colorectal Cancer NCT01032291

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. metastatic colorectal adenocarcinoma.
Beschreibung

Adenocarcinoma of large intestine metastatic

Datentyp

boolean

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

KRAS mutation Tumor

Datentyp

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.
Beschreibung

Disease Progression | oxaliplatin | irinotecan | bevacizumab

Datentyp

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.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschreibung

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Therapeutic radiology procedure Bone Marrow Percentage

Datentyp

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).
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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).
Beschreibung

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

Datentyp

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.
Beschreibung

Venous Thromboembolism

Datentyp

boolean

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

Congestive heart failure New York Heart Association Classification

Datentyp

boolean

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

Myocardial Infarction

Datentyp

boolean

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

Uncontrolled hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
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Ähnliche Modelle

Eligibility Colorectal Cancer NCT01032291

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