ID

16923

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00251485

Nyckelord

Versioner (1)
  1. 2016-08-14 2016-08-14 -
Uppladdad den

14 augusti 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00251485

Engelsk

Eligibility Colorectal Cancer NCT00251485

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

informed consent

Datatyp

boolean

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

adenocarcinoma of the colon or rectum

Datatyp

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).
Beskrivning

inoperable disease

Datatyp

boolean

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

egfr

Datatyp

boolean

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

ecog performance status

Datatyp

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.
Beskrivning

age, pregnancy, sterile, postmenopausal

Datatyp

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).
Beskrivning

bone marrow function, neutrophil count, platelets

Datatyp

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.
Beskrivning

creatinine

Datatyp

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.
Beskrivning

bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
Exclusion Criteria
Beskrivning

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.
Beskrivning

prior chemotherapy

Datatyp

boolean

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

oxaliplatin

Datatyp

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.
Beskrivning

cetuximab

Datatyp

boolean

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

acute hepatitis

Datatyp

boolean

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

active or uncontrolled infection

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

allergic reaction to chimerized or murine monoclonal antibody therapy

Datatyp

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.
Beskrivning

concurrent chemotherapy or any other investigational agent

Datatyp

boolean

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

peripheral neuropathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0031117
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Similar models

Eligibility Colorectal Cancer NCT00251485

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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