ID

31513

Description

Evaluate Efficacy and Safety of XELOX in Potentially Resectable Liver Metastasis From Colorectal Cancer(CRC); ODM derived from: https://clinicaltrials.gov/show/NCT00997685

Lien

https://clinicaltrials.gov/show/NCT00997685

Mots-clés

Versions (1)
  1. 30/08/2018 30/08/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

30 août 2018

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.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

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

Eligibility Potentially Resectable Liver Metastasis From CRC NCT00997685

Anglais

Eligibility Potentially Resectable Liver Metastasis From CRC NCT00997685

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age of 18 and 65
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed colorectal cancer and two methords of imaging detection confirmed liver metastasis
Description

Colorectal Carcinoma | Secondary malignant neoplasm of liver Imaging Techniques Quantity

Type de données

boolean

Alias
UMLS CUI [1]
C0009402
UMLS CUI [2,1]
C0494165
UMLS CUI [2,2]
C0079595
UMLS CUI [2,3]
C1265611
potentially curable by resection, as determined by a surgeon with hepatic surgery expertise
Description

Cure of disease Possible | Excision

Type de données

boolean

Alias
UMLS CUI [1,1]
C0679252
UMLS CUI [1,2]
C0332149
UMLS CUI [2]
C0728940
no evidence of extrahepatic disease by chest x-ray or ct scan of the chest, abdomen, and pelvis
Description

Absence Disease Extrahepatic Chest X-ray | Absence Disease Extrahepatic Chest CT | Absence Disease Extrahepatic X-ray abdomen | Absence Disease Extrahepatic CT of abdomen | Absence Disease Extrahepatic Pelvis X-ray | Absence Disease Extrahepatic CT of Pelvis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C1517058
UMLS CUI [1,4]
C0039985
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C1517058
UMLS CUI [2,4]
C0202823
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C1517058
UMLS CUI [3,4]
C0581165
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C1517058
UMLS CUI [4,4]
C0412620
UMLS CUI [5,1]
C0332197
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C1517058
UMLS CUI [5,4]
C0554740
UMLS CUI [6,1]
C0332197
UMLS CUI [6,2]
C0012634
UMLS CUI [6,3]
C1517058
UMLS CUI [6,4]
C0412628
patients with adequate hepative, renal and bone marrow function
Description

Liver function | Renal function | Bone Marrow function

Type de données

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0031843
signed written informed consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or nursing patients (fertile patients must use effective contraception)
Description

Pregnancy | Breast Feeding | Fertility Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0015895
UMLS CUI [3,2]
C0700589
other malignancy within the past 5 years except completely resected nonmelanoma skin cancer or carcinoma in situ of the cervix
Description

Cancer Other | Exception Complete excision Skin carcinoma | Exception Complete excision Carcinoma in situ of uterine cervix

Type de données

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0015250
UMLS CUI [2,3]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0015250
UMLS CUI [3,3]
C0851140
preexisting grade 2 or greater peripheral neuropathy
Description

Peripheral Neuropathy Pre-existing CTCAE Grades

Type de données

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
concurrent uncontrolled illness
Description

Comorbidity Uncontrolled

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
ongoing or active infection
Description

Communicable Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0009450
psychiatric illness or social situation that would preclude study compliance
Description

Mental disorders Exclude Protocol Compliance | Social situation Excludes Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0525058
less than 6 months since prior adjuvant fluorouracil-based chemotherapy
Description

Chemotherapy, Adjuvant | Fluorouracil

Type de données

boolean

Alias
UMLS CUI [1]
C0085533
UMLS CUI [2]
C0016360
prior chemotherapy for liver metastasis
Description

Prior Chemotherapy Secondary malignant neoplasm of liver

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0494165
prior oxaliplatin for colorectal cancer
Description

Oxaliplatin | Colorectal Carcinoma

Type de données

boolean

Alias
UMLS CUI [1]
C0069717
UMLS CUI [2]
C0009402
prior or concurrent hepatic artery infusion chemotherapy for metastatic disease
Description

Hepatic Artery Infusion Chemotherapy Neoplasm Metastasis

Type de données

boolean

Alias
UMLS CUI [1,1]
C1134564
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0027627
prior or concurrent radiotherapy for metastatic disease
Description

Therapeutic radiology procedure Neoplasm Metastasis

Type de données

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0027627
prior or concurrent radiofrequency ablation for metastatic disease
Description

Radiofrequency ablation Neoplasm Metastasis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0850292
UMLS CUI [1,2]
C0027627
concurrent treatment with any other anti-cancer therapy.
Description

Cancer treatment Other

Type de données

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
Retour au début de la page

Similar models

Eligibility Potentially Resectable Liver Metastasis From CRC NCT00997685

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age of 18 and 65
boolean
C0001779 (UMLS CUI [1])
Colorectal Carcinoma | Secondary malignant neoplasm of liver Imaging Techniques Quantity
Item
histologically confirmed colorectal cancer and two methords of imaging detection confirmed liver metastasis
boolean
C0009402 (UMLS CUI [1])
C0494165 (UMLS CUI [2,1])
C0079595 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Cure of disease Possible | Excision
Item
potentially curable by resection, as determined by a surgeon with hepatic surgery expertise
boolean
C0679252 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
C0728940 (UMLS CUI [2])
Absence Disease Extrahepatic Chest X-ray | Absence Disease Extrahepatic Chest CT | Absence Disease Extrahepatic X-ray abdomen | Absence Disease Extrahepatic CT of abdomen | Absence Disease Extrahepatic Pelvis X-ray | Absence Disease Extrahepatic CT of Pelvis
Item
no evidence of extrahepatic disease by chest x-ray or ct scan of the chest, abdomen, and pelvis
boolean
C0332197 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1517058 (UMLS CUI [1,3])
C0039985 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C1517058 (UMLS CUI [2,3])
C0202823 (UMLS CUI [2,4])
C0332197 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C1517058 (UMLS CUI [3,3])
C0581165 (UMLS CUI [3,4])
C0332197 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C1517058 (UMLS CUI [4,3])
C0412620 (UMLS CUI [4,4])
C0332197 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C1517058 (UMLS CUI [5,3])
C0554740 (UMLS CUI [5,4])
C0332197 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
C1517058 (UMLS CUI [6,3])
C0412628 (UMLS CUI [6,4])
Liver function | Renal function | Bone Marrow function
Item
patients with adequate hepative, renal and bone marrow function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Fertility Contraceptive methods
Item
pregnant or nursing patients (fertile patients must use effective contraception)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0015895 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Cancer Other | Exception Complete excision Skin carcinoma | Exception Complete excision Carcinoma in situ of uterine cervix
Item
other malignancy within the past 5 years except completely resected nonmelanoma skin cancer or carcinoma in situ of the cervix
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0015250 (UMLS CUI [2,2])
C0699893 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0015250 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
Peripheral Neuropathy Pre-existing CTCAE Grades
Item
preexisting grade 2 or greater peripheral neuropathy
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Comorbidity Uncontrolled
Item
concurrent uncontrolled illness
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Communicable Disease
Item
ongoing or active infection
boolean
C0009450 (UMLS CUI [1])
Mental disorders Exclude Protocol Compliance | Social situation Excludes Protocol Compliance
Item
psychiatric illness or social situation that would preclude study compliance
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Chemotherapy, Adjuvant | Fluorouracil
Item
less than 6 months since prior adjuvant fluorouracil-based chemotherapy
boolean
C0085533 (UMLS CUI [1])
C0016360 (UMLS CUI [2])
Prior Chemotherapy Secondary malignant neoplasm of liver
Item
prior chemotherapy for liver metastasis
boolean
C1514457 (UMLS CUI [1,1])
C0494165 (UMLS CUI [1,2])
Oxaliplatin | Colorectal Carcinoma
Item
prior oxaliplatin for colorectal cancer
boolean
C0069717 (UMLS CUI [1])
C0009402 (UMLS CUI [2])
Hepatic Artery Infusion Chemotherapy Neoplasm Metastasis
Item
prior or concurrent hepatic artery infusion chemotherapy for metastatic disease
boolean
C1134564 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Therapeutic radiology procedure Neoplasm Metastasis
Item
prior or concurrent radiotherapy for metastatic disease
boolean
C1522449 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Radiofrequency ablation Neoplasm Metastasis
Item
prior or concurrent radiofrequency ablation for metastatic disease
boolean
C0850292 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Cancer treatment Other
Item
concurrent treatment with any other anti-cancer therapy.
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Retour au début de la page 

Contact

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

Les champs marqués d’un * sont obligatoires.

Aide

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