ID

16992

Beschrijving

A Study of Mitomycin C, Irinotecan, and Cetuximab; ODM derived from: https://clinicaltrials.gov/show/NCT00271011

Link

https://clinicaltrials.gov/show/NCT00271011

Trefwoorden

  1. 18-08-16 18-08-16 -
Geüploaded op

18 augustus 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Colorectal Cancer NCT00271011

Eligibility Colorectal Cancer NCT00271011

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. pathologic diagnosis of colorectal cancer.
Beschrijving

diagnosis of colorectal cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0009402
2. clinical and/or radiologic evidence of metastatic disease.
Beschrijving

metastatic disease

Datatype

boolean

Alias
UMLS CUI [1]
C0027627
3. one previous systemic treatment for metastatic disease.
Beschrijving

previous treatment for metastatic disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C2114510
UMLS CUI [1,2]
C0027627
4. age > 18.
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
5. presence of at least one measurable lesion.
Beschrijving

measurable lesion

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
6. adequate hematopoetic (absolute neutrophil count > 1500/mm3, platelet count > 100,000/mm3), renal (serum creatinine < 1.5 mg/dl), and hepatic function (bilirubin < 1.5 and transaminases < 5.0 x upper normal limit).
Beschrijving

neutrophil count, platelets, creatinine, bilirubin, transaminases

Datatype

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0005821
UMLS CUI [3]
C0201976
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0002594
7. ecog performance status 0-2.
Beschrijving

ecog performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
8. life expectancy > 3 months.
Beschrijving

life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
9. patients must be informed of the investigational nature of this study and provide written informed consent in accordance with the institutional and federal guidelines prior to the initiation of therapy.
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. no recognized brain metastasis.
Beschrijving

brain metastasis

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
2. no previous treatment with mitomycin c or cetuximab.
Beschrijving

mitomycin c or cetuximab

Datatype

boolean

Alias
UMLS CUI [1]
C0002475
UMLS CUI [2]
C0995188
3. no other systemic malignancy requiring treatment within the past one year.
Beschrijving

comorbidity, malignant neoplasm

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0006826
4. pregnant or lactating women may not participate. women/men of reproductive potential must agree to use an effective contraceptive method.
Beschrijving

pregnancy, contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0700589
5. patients must have no other serious medical or psychiatric illness that would limit the ability of the patient to receive protocol therapy or provide informed consent.
Beschrijving

no other serious medical or psychiatric illness

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0004936

Similar models

Eligibility Colorectal Cancer NCT00271011

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
diagnosis of colorectal cancer
Item
1. pathologic diagnosis of colorectal cancer.
boolean
C0011900 (UMLS CUI [1,1])
C0009402 (UMLS CUI [1,2])
metastatic disease
Item
2. clinical and/or radiologic evidence of metastatic disease.
boolean
C0027627 (UMLS CUI [1])
previous treatment for metastatic disease
Item
3. one previous systemic treatment for metastatic disease.
boolean
C2114510 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
age
Item
4. age > 18.
boolean
C0001779 (UMLS CUI [1])
measurable lesion
Item
5. presence of at least one measurable lesion.
boolean
C1513041 (UMLS CUI [1])
neutrophil count, platelets, creatinine, bilirubin, transaminases
Item
6. adequate hematopoetic (absolute neutrophil count > 1500/mm3, platelet count > 100,000/mm3), renal (serum creatinine < 1.5 mg/dl), and hepatic function (bilirubin < 1.5 and transaminases < 5.0 x upper normal limit).
boolean
C0200633 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0002594 (UMLS CUI [5])
ecog performance status
Item
7. ecog performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
life expectancy
Item
8. life expectancy > 3 months.
boolean
C0023671 (UMLS CUI [1])
informed consent
Item
9. patients must be informed of the investigational nature of this study and provide written informed consent in accordance with the institutional and federal guidelines prior to the initiation of therapy.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
brain metastasis
Item
1. no recognized brain metastasis.
boolean
C0220650 (UMLS CUI [1])
mitomycin c or cetuximab
Item
2. no previous treatment with mitomycin c or cetuximab.
boolean
C0002475 (UMLS CUI [1])
C0995188 (UMLS CUI [2])
comorbidity, malignant neoplasm
Item
3. no other systemic malignancy requiring treatment within the past one year.
boolean
C0009488 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
pregnancy, contraceptive methods
Item
4. pregnant or lactating women may not participate. women/men of reproductive potential must agree to use an effective contraceptive method.
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
no other serious medical or psychiatric illness
Item
5. patients must have no other serious medical or psychiatric illness that would limit the ability of the patient to receive protocol therapy or provide informed consent.
boolean
C0009488 (UMLS CUI [1])
C0004936 (UMLS CUI [2])

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