ID

16923

Descripción

A Phase II Trial of Modified FOLFOX 6 and Cetuximab in First Line Treatment of Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00251485

Link

https://clinicaltrials.gov/show/NCT00251485

Palabras clave

  1. 14/8/16 14/8/16 -
Subido en

14 de agosto de 2016

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Colorectal Cancer NCT00251485

Eligibility Colorectal Cancer NCT00251485

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have signed an irb approved informed consent.
Descripción

informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
2. patients with histologically or pathologically documented, stage iiib or iv adenocarcinoma of the colon or rectum.
Descripción

adenocarcinoma of the colon or rectum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011900
UMLS CUI [2]
C0338106
UMLS CUI [3]
C0149978
3. patients with disease that is not amenable to potentially curative resection (i.e., inoperable metastatic disease).
Descripción

inoperable disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205187
4. patients with tumors that are egfr + by ihc staining.
Descripción

egfr

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0034802
UMLS CUI [1,2]
C0021044
5. patients with ecog performance status of 0 or 1.
Descripción

ecog performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
6. patients, 18 years and older, must either be not of child bearing potential or have a negative serum pregnancy test within 7 days prior to registration. patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal.
Descripción

age, pregnancy, sterile, postmenopausal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0021359
UMLS CUI [4]
C0232970
7. bone marrow function: absolute neutrophil count (anc) > or = 1,500/ul, equivalent to common terminology criteria for adverse events (ctcae, version 3) grade 1. platelets > or = 100,000/ul (ctcae grade 0 - 1).
Descripción

bone marrow function, neutrophil count, platelets

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0005821
8. renal function: creatinine < or = 1.5 x institutional upper limit of normal (uln), ctcae grade 1.
Descripción

creatinine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
9. hepatic function: bilirubin < or = 1.5 x uln, ctcae grade 1. ast < or = 2.5 x uln, ctcae grade 1.
Descripción

bilirubin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who received prior chemotherapy for metastatic disease. prior adjuvant therapy with 5fu/lv and/or irinotecan is allowed provided it was completed at least 6 months prior to enrollment in this study.
Descripción

prior chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1514457
2. patents who received prior oxaliplatin.
Descripción

oxaliplatin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0069717
UMLS CUI [1,2]
C1514457
3. patients who received prior cetuximab or other therapy which specifically and directly targets the egf pathway.
Descripción

cetuximab

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0995188
UMLS CUI [1,2]
C1514457
4. patients with acute hepatitis.
Descripción

acute hepatitis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0267797
5. patients with active or uncontrolled infection.
Descripción

active or uncontrolled infection

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205177
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
6. patients with a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, and congestive heart failure.
Descripción

cardiac disease, uncontrolled hypertension, unstable angina, and congestive heart failure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0018802
7. prior allergic reaction to chimerized or murine monoclonal antibody therapy.
Descripción

allergic reaction to chimerized or murine monoclonal antibody therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0003250
8. any concurrent chemotherapy not indicated in the study protocol or any other investigational agent.
Descripción

concurrent chemotherapy or any other investigational agent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205420
UMLS CUI [2]
C0013230
9. patients with peripheral neuropathy > grade 1
Descripción

peripheral neuropathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0031117

Similar models

Eligibility Colorectal Cancer NCT00251485

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
1. patients must have signed an irb approved informed consent.
boolean
C0021430 (UMLS CUI [1])
adenocarcinoma of the colon or rectum
Item
2. patients with histologically or pathologically documented, stage iiib or iv adenocarcinoma of the colon or rectum.
boolean
C0011900 (UMLS CUI [1])
C0338106 (UMLS CUI [2])
C0149978 (UMLS CUI [3])
inoperable disease
Item
3. patients with disease that is not amenable to potentially curative resection (i.e., inoperable metastatic disease).
boolean
C0006826 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
egfr
Item
4. patients with tumors that are egfr + by ihc staining.
boolean
C0034802 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
ecog performance status
Item
5. patients with ecog performance status of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
age, pregnancy, sterile, postmenopausal
Item
6. patients, 18 years and older, must either be not of child bearing potential or have a negative serum pregnancy test within 7 days prior to registration. patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal.
boolean
C0001779 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0021359 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
bone marrow function, neutrophil count, platelets
Item
7. bone marrow function: absolute neutrophil count (anc) > or = 1,500/ul, equivalent to common terminology criteria for adverse events (ctcae, version 3) grade 1. platelets > or = 100,000/ul (ctcae grade 0 - 1).
boolean
C0200633 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
creatinine
Item
8. renal function: creatinine < or = 1.5 x institutional upper limit of normal (uln), ctcae grade 1.
boolean
C0201976 (UMLS CUI [1])
bilirubin
Item
9. hepatic function: bilirubin < or = 1.5 x uln, ctcae grade 1. ast < or = 2.5 x uln, ctcae grade 1.
boolean
C1278039 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
prior chemotherapy
Item
1. patients who received prior chemotherapy for metastatic disease. prior adjuvant therapy with 5fu/lv and/or irinotecan is allowed provided it was completed at least 6 months prior to enrollment in this study.
boolean
C1514457 (UMLS CUI [1])
oxaliplatin
Item
2. patents who received prior oxaliplatin.
boolean
C0069717 (UMLS CUI [1,1])
C1514457 (UMLS CUI [1,2])
cetuximab
Item
3. patients who received prior cetuximab or other therapy which specifically and directly targets the egf pathway.
boolean
C0995188 (UMLS CUI [1,1])
C1514457 (UMLS CUI [1,2])
acute hepatitis
Item
4. patients with acute hepatitis.
boolean
C0267797 (UMLS CUI [1])
active or uncontrolled infection
Item
5. patients with active or uncontrolled infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
cardiac disease, uncontrolled hypertension, unstable angina, and congestive heart failure
Item
6. patients with a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, and congestive heart failure.
boolean
C0018799 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
allergic reaction to chimerized or murine monoclonal antibody therapy
Item
7. prior allergic reaction to chimerized or murine monoclonal antibody therapy.
boolean
C1527304 (UMLS CUI [1,1])
C0003250 (UMLS CUI [1,2])
concurrent chemotherapy or any other investigational agent
Item
8. any concurrent chemotherapy not indicated in the study protocol or any other investigational agent.
boolean
C0392920 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
peripheral neuropathy
Item
9. patients with peripheral neuropathy > grade 1
boolean
C0031117 (UMLS CUI [1])

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