ID

23813

Description

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

Lien

https://clinicaltrials.gov/show/NCT00478634

Mots-clés

  1. 14/07/2017 14/07/2017 -
Téléchargé le

14 juillet 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Colorectal Cancer NCT00478634

Eligibility Colorectal Cancer NCT00478634

Inclusion Criteria
Description

Inclusion Criteria

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

Age

Type de données

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.
Description

Colorectal cancer metastatic | Primary tumor Excision

Type de données

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.
Description

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

Type de données

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.
Description

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

Type de données

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.
Description

WHO performance status scale

Type de données

boolean

Alias
UMLS CUI [1]
C1298650
Exclusion Criteria
Description

Exclusion Criteria

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

Gilbert Disease | Glucuronidation Deficiency Bilirubin

Type de données

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.
Description

Patient Homozygous UGT1A1*28 Allele | Sequencing

Type de données

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.
Description

irinotecan

Type de données

boolean

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

mTOR Inhibitor

Type de données

boolean

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

Clinical Trial Eligibility Criteria Study Protocol

Type de données

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)
Type de données
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])

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial