ID

23813

Beschrijving

A Phase 1 Study Investigating the Combination of RAD001, Cetuximab and Irinotecan as Second-line Therapy After FOLFOX (or XELOX) Plus Bevacizumab in Patients With Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00478634

Link

https://clinicaltrials.gov/show/NCT00478634

Trefwoorden

  1. 14-07-17 14-07-17 -
Geüploaded op

14 juli 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Colorectal Cancer NCT00478634

Eligibility Colorectal Cancer NCT00478634

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years old and ≤ 65 years old.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients with metastatic crc. confirmation of crc diagnosis by histological or cytological specimen from original resection of primary tumor.
Beschrijving

Colorectal cancer metastatic | Primary tumor Excision

Datatype

boolean

Alias
UMLS CUI [1]
C0948380
UMLS CUI [2,1]
C0677930
UMLS CUI [2,2]
C0728940
patients who progressed despite prior therapy with folfox (5fu and oxaliplatin) plus bevacizumab or xelox (capecitabine and oxaliplatin) plus bevacizumab.
Beschrijving

Disease Progression | FOLFOX Regimen | Fluorouracil | oxaliplatin | bevacizumab | Xeloda-Oxaliplatin Regimen | capecitabine

Datatype

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0392943
UMLS CUI [3]
C0016360
UMLS CUI [4]
C0069717
UMLS CUI [5]
C0796392
UMLS CUI [6]
C1956962
UMLS CUI [7]
C0671970
patients with at least one measurable lesion by recist as determined by computer tomography (ct) scan, magnetic resonance imaging (mri) or physical examination.
Beschrijving

Measurable Disease Quantity | X-Ray Computed Tomography | Magnetic Resonance Imaging | Physical Examination

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0040405
UMLS CUI [3]
C0024485
UMLS CUI [4]
C0031809
patients with a who performance status of 0 or 1.
Beschrijving

WHO performance status scale

Datatype

boolean

Alias
UMLS CUI [1]
C1298650
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with gilbert's syndrome or any other syndrome associated with deficient glucoronidation of bilirubin.
Beschrijving

Gilbert Disease | Glucuronidation Deficiency Bilirubin

Datatype

boolean

Alias
UMLS CUI [1]
C0017551
UMLS CUI [2,1]
C1880989
UMLS CUI [2,2]
C0011155
UMLS CUI [2,3]
C0005437
patients who are homozygous for the ugt1a1*28 allele as determined by sequencing.
Beschrijving

Patient Homozygous UGT1A1*28 Allele | Sequencing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0019904
UMLS CUI [1,3]
C2825127
UMLS CUI [2]
C1294197
patients who have received previous irinotecan-based therapy.
Beschrijving

irinotecan

Datatype

boolean

Alias
UMLS CUI [1]
C0123931
prior treatment with an mtor inhibitor.
Beschrijving

mTOR Inhibitor

Datatype

boolean

Alias
UMLS CUI [1]
C2746052
other protocol-defined inclusion/exclusion criteria may apply
Beschrijving

Clinical Trial Eligibility Criteria Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563

Similar models

Eligibility Colorectal Cancer NCT00478634

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 18 years old and ≤ 65 years old.
boolean
C0001779 (UMLS CUI [1])
Colorectal cancer metastatic | Primary tumor Excision
Item
patients with metastatic crc. confirmation of crc diagnosis by histological or cytological specimen from original resection of primary tumor.
boolean
C0948380 (UMLS CUI [1])
C0677930 (UMLS CUI [2,1])
C0728940 (UMLS CUI [2,2])
Disease Progression | FOLFOX Regimen | Fluorouracil | oxaliplatin | bevacizumab | Xeloda-Oxaliplatin Regimen | capecitabine
Item
patients who progressed despite prior therapy with folfox (5fu and oxaliplatin) plus bevacizumab or xelox (capecitabine and oxaliplatin) plus bevacizumab.
boolean
C0242656 (UMLS CUI [1])
C0392943 (UMLS CUI [2])
C0016360 (UMLS CUI [3])
C0069717 (UMLS CUI [4])
C0796392 (UMLS CUI [5])
C1956962 (UMLS CUI [6])
C0671970 (UMLS CUI [7])
Measurable Disease Quantity | X-Ray Computed Tomography | Magnetic Resonance Imaging | Physical Examination
Item
patients with at least one measurable lesion by recist as determined by computer tomography (ct) scan, magnetic resonance imaging (mri) or physical examination.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0040405 (UMLS CUI [2])
C0024485 (UMLS CUI [3])
C0031809 (UMLS CUI [4])
WHO performance status scale
Item
patients with a who performance status of 0 or 1.
boolean
C1298650 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Gilbert Disease | Glucuronidation Deficiency Bilirubin
Item
patients with gilbert's syndrome or any other syndrome associated with deficient glucoronidation of bilirubin.
boolean
C0017551 (UMLS CUI [1])
C1880989 (UMLS CUI [2,1])
C0011155 (UMLS CUI [2,2])
C0005437 (UMLS CUI [2,3])
Patient Homozygous UGT1A1*28 Allele | Sequencing
Item
patients who are homozygous for the ugt1a1*28 allele as determined by sequencing.
boolean
C0030705 (UMLS CUI [1,1])
C0019904 (UMLS CUI [1,2])
C2825127 (UMLS CUI [1,3])
C1294197 (UMLS CUI [2])
irinotecan
Item
patients who have received previous irinotecan-based therapy.
boolean
C0123931 (UMLS CUI [1])
mTOR Inhibitor
Item
prior treatment with an mtor inhibitor.
boolean
C2746052 (UMLS CUI [1])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])

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