ID

16923

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT00251485

Keywords

versioni (1)
  1. 14/08/16 14/08/16 -
Caricato su

14 agosto 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Colorectal Cancer NCT00251485

Inglese

Eligibility Colorectal Cancer NCT00251485

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

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

informed consent

Tipo di dati

boolean

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

adenocarcinoma of the colon or rectum

Tipo di dati

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).
Descrizione

inoperable disease

Tipo di dati

boolean

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

egfr

Tipo di dati

boolean

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

ecog performance status

Tipo di dati

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.
Descrizione

age, pregnancy, sterile, postmenopausal

Tipo di dati

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).
Descrizione

bone marrow function, neutrophil count, platelets

Tipo di dati

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.
Descrizione

creatinine

Tipo di dati

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.
Descrizione

bilirubin

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1278039
Exclusion Criteria
Descrizione

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.
Descrizione

prior chemotherapy

Tipo di dati

boolean

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

oxaliplatin

Tipo di dati

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.
Descrizione

cetuximab

Tipo di dati

boolean

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

acute hepatitis

Tipo di dati

boolean

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

active or uncontrolled infection

Tipo di dati

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.
Descrizione

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

Tipo di dati

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.
Descrizione

allergic reaction to chimerized or murine monoclonal antibody therapy

Tipo di dati

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.
Descrizione

concurrent chemotherapy or any other investigational agent

Tipo di dati

boolean

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

peripheral neuropathy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0031117
Ritorna all'inizio della pagina

Similar models

Eligibility Colorectal Cancer NCT00251485

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

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