ID

20214

Descripción

Combination of Cetuximab, Capecitabine, and Oxaliplatin With or Without Bevacizumab; ODM derived from: https://clinicaltrials.gov/show/NCT00321100

Link

https://clinicaltrials.gov/show/NCT00321100

Palabras clave

Versiones (1)
  1. 14/2/17 14/2/17 -
Subido en

14 de febrero de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Colorectal Neoplasms NCT00321100

Inglés

Eligibility Colorectal Neoplasms NCT00321100

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
measurable metastatic adenocarcinoma of the colon or rectum
Descripción

Adenocarcinoma of colon metastatic Measurable | Adenocarcinoma of rectum metastatic Measurable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0338106
UMLS CUI [1,2]
C1522484
UMLS CUI [1,3]
C1513040
UMLS CUI [2,1]
C0149978
UMLS CUI [2,2]
C1522484
UMLS CUI [2,3]
C1513040
no prior systemic therapy for metastatic disease
Descripción

systemic therapy Neoplasm Metastasis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0027627
adjuvant therapy must have been completed >/=12 months prior to recurrence, prior radiotherapy permitted but must have been completed > 6 months prior to study entry
Descripción

Adjuvant therapy Completed | Recurrence | Therapeutic radiology procedure Completed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0677850
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C0034897
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0205197
must have tumor tissue available for egfr and thymidine phosphorylase evaluation
Descripción

Tumor tissue Available Epidermal Growth Factor Receptor Evaluation | Tumor tissue Available Thymidine Phosphorylase Evaluation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0034802
UMLS CUI [1,4]
C1261322
UMLS CUI [2,1]
C0475358
UMLS CUI [2,2]
C0470187
UMLS CUI [2,3]
C0040083
UMLS CUI [2,4]
C1261322
ecog ps 0-1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
age >/= 18
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
adequate organ function: wbc>/=3,000, anc >/=1,500, platelets>/= 100,000, total bilirubin </= 1.5x uln, ast&alt </= 2.5x uln, create clearance >/= 50ml/min
Descripción

Organ function | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine clearance measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201836
UMLS CUI [8]
C0373595
negative pregnancy test w/in 72 hours of treatment for women of child bearing potential
Descripción

Childbearing Potential Pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
ability to understand and willing to sign written icf
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
able to swallow and absorb oral medication
Descripción

Able to swallow oral medication | Oral medication Absorption Ability

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
UMLS CUI [2,1]
C0175795
UMLS CUI [2,2]
C0237442
UMLS CUI [2,3]
C0085732
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
medical or psychiatric condition which would potentially pose risk to patient by participation (i.e. but not limited to:uncontrolled hypertension, mi w/in 6 months,cns disease, pregnancy or nursing)
Descripción

Medical condition Study Subject Participation Status At risk | Mental condition Study Subject Participation Status At risk | Uncontrolled hypertension | Myocardial Infarction | CNS disorder | Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
UMLS CUI [3]
C1868885
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0007682
UMLS CUI [6]
C0032961
UMLS CUI [7]
C0006147
history of neoplasm (other than non-metastatic skin cancer or carcinoma in situ of cervix) w/in 5 years
Descripción

Neoplasms | Skin carcinoma nonmetastatic | Carcinoma in situ of uterine cervix

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027651
UMLS CUI [2,1]
C0699893
UMLS CUI [2,2]
C1518409
UMLS CUI [3]
C0851140
surgical procedure (not including closed biopsy or access port placement), open biopsy, significant traumatic injury w/in 28 days of registration or anticipation of need for surgical procedure while on study, fine needle aspiration or core biopsy w/in 7 days of registration
Descripción

Operative Surgical Procedures | Biopsy Closed | Injection/Infusion Ports Implantation | Incisional biopsy | Traumatic injury | Operative Surgical Procedures Patient need for | Fine needle aspiration biopsy | Core needle biopsy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C0677512
UMLS CUI [3,1]
C0042371
UMLS CUI [3,2]
C0021107
UMLS CUI [4]
C0184922
UMLS CUI [5]
C3263723
UMLS CUI [6,1]
C0543467
UMLS CUI [6,2]
C0686904
UMLS CUI [7]
C1510483
UMLS CUI [8]
C1318309
urine protein:creatinine ration >/=1.0 at screening
Descripción

Urine protein/creatinine ratio measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1096054
evidence of bleeding diathesis or coagulopathy (in absence of anticoagulation)
Descripción

Bleeding tendency Evidence of | Blood Coagulation Disorders | Anticoagulation Therapy Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1458140
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C0005779
UMLS CUI [3,1]
C0003281
UMLS CUI [3,2]
C0332197
prior severe infusion reaction to mab or allergic reaction to capecitabine or oxaliplatin
Descripción

Infusion related reaction Severe Monoclonal Antibodies | Allergic Reaction capecitabine | Allergic Reaction oxaliplatin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0948715
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0003250
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0671970
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0069717
underlying neuropathy >/= grade 2
Descripción

Neuropathy CTCAE Grades

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
tia or cva w/in 6 months
Descripción

Transient Ischemic Attack | Cerebrovascular accident

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007787
UMLS CUI [2]
C0038454
Volver a la parte superior de la página

Similar models

Eligibility Colorectal Neoplasms NCT00321100

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of colon metastatic Measurable | Adenocarcinoma of rectum metastatic Measurable
Item
measurable metastatic adenocarcinoma of the colon or rectum
boolean
C0338106 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C1513040 (UMLS CUI [1,3])
C0149978 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C1513040 (UMLS CUI [2,3])
systemic therapy Neoplasm Metastasis
Item
no prior systemic therapy for metastatic disease
boolean
C1515119 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Adjuvant therapy Completed | Recurrence | Therapeutic radiology procedure Completed
Item
adjuvant therapy must have been completed >/=12 months prior to recurrence, prior radiotherapy permitted but must have been completed > 6 months prior to study entry
boolean
C0677850 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0034897 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
Tumor tissue Available Epidermal Growth Factor Receptor Evaluation | Tumor tissue Available Thymidine Phosphorylase Evaluation
Item
must have tumor tissue available for egfr and thymidine phosphorylase evaluation
boolean
C0475358 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0034802 (UMLS CUI [1,3])
C1261322 (UMLS CUI [1,4])
C0475358 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C0040083 (UMLS CUI [2,3])
C1261322 (UMLS CUI [2,4])
ECOG performance status
Item
ecog ps 0-1
boolean
C1520224 (UMLS CUI [1])
Age
Item
age >/= 18
boolean
C0001779 (UMLS CUI [1])
Organ function | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine clearance measurement
Item
adequate organ function: wbc>/=3,000, anc >/=1,500, platelets>/= 100,000, total bilirubin </= 1.5x uln, ast&alt </= 2.5x uln, create clearance >/= 50ml/min
boolean
C0678852 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
C0373595 (UMLS CUI [8])
Childbearing Potential Pregnancy test negative
Item
negative pregnancy test w/in 72 hours of treatment for women of child bearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Informed Consent
Item
ability to understand and willing to sign written icf
boolean
C0021430 (UMLS CUI [1])
Able to swallow oral medication | Oral medication Absorption Ability
Item
able to swallow and absorb oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0175795 (UMLS CUI [2,1])
C0237442 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Medical condition Study Subject Participation Status At risk | Mental condition Study Subject Participation Status At risk | Uncontrolled hypertension | Myocardial Infarction | CNS disorder | Pregnancy | Breast Feeding
Item
medical or psychiatric condition which would potentially pose risk to patient by participation (i.e. but not limited to:uncontrolled hypertension, mi w/in 6 months,cns disease, pregnancy or nursing)
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C1868885 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0007682 (UMLS CUI [5])
C0032961 (UMLS CUI [6])
C0006147 (UMLS CUI [7])
Neoplasms | Skin carcinoma nonmetastatic | Carcinoma in situ of uterine cervix
Item
history of neoplasm (other than non-metastatic skin cancer or carcinoma in situ of cervix) w/in 5 years
boolean
C0027651 (UMLS CUI [1])
C0699893 (UMLS CUI [2,1])
C1518409 (UMLS CUI [2,2])
C0851140 (UMLS CUI [3])
Operative Surgical Procedures | Biopsy Closed | Injection/Infusion Ports Implantation | Incisional biopsy | Traumatic injury | Operative Surgical Procedures Patient need for | Fine needle aspiration biopsy | Core needle biopsy
Item
surgical procedure (not including closed biopsy or access port placement), open biopsy, significant traumatic injury w/in 28 days of registration or anticipation of need for surgical procedure while on study, fine needle aspiration or core biopsy w/in 7 days of registration
boolean
C0543467 (UMLS CUI [1])
C0005558 (UMLS CUI [2,1])
C0677512 (UMLS CUI [2,2])
C0042371 (UMLS CUI [3,1])
C0021107 (UMLS CUI [3,2])
C0184922 (UMLS CUI [4])
C3263723 (UMLS CUI [5])
C0543467 (UMLS CUI [6,1])
C0686904 (UMLS CUI [6,2])
C1510483 (UMLS CUI [7])
C1318309 (UMLS CUI [8])
Urine protein/creatinine ratio measurement
Item
urine protein:creatinine ration >/=1.0 at screening
boolean
C1096054 (UMLS CUI [1])
Bleeding tendency Evidence of | Blood Coagulation Disorders | Anticoagulation Therapy Absent
Item
evidence of bleeding diathesis or coagulopathy (in absence of anticoagulation)
boolean
C1458140 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0005779 (UMLS CUI [2])
C0003281 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Infusion related reaction Severe Monoclonal Antibodies | Allergic Reaction capecitabine | Allergic Reaction oxaliplatin
Item
prior severe infusion reaction to mab or allergic reaction to capecitabine or oxaliplatin
boolean
C0948715 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0003250 (UMLS CUI [1,3])
C1527304 (UMLS CUI [2,1])
C0671970 (UMLS CUI [2,2])
C1527304 (UMLS CUI [3,1])
C0069717 (UMLS CUI [3,2])
Neuropathy CTCAE Grades
Item
underlying neuropathy >/= grade 2
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Transient Ischemic Attack | Cerebrovascular accident
Item
tia or cva w/in 6 months
boolean
C0007787 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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