ID

16992

Description

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

Link

https://clinicaltrials.gov/show/NCT00271011

Keywords

Versions (1)
  1. 8/18/16 8/18/16 -
Uploaded on

August 18, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00271011

English

Eligibility Colorectal Cancer NCT00271011

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

diagnosis of colorectal cancer

Data type

boolean

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

metastatic disease

Data type

boolean

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

previous treatment for metastatic disease

Data type

boolean

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

age

Data type

boolean

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

measurable lesion

Data type

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).
Description

neutrophil count, platelets, creatinine, bilirubin, transaminases

Data type

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.
Description

ecog performance status

Data type

boolean

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

life expectancy

Data type

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.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

brain metastasis

Data type

boolean

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

mitomycin c or cetuximab

Data type

boolean

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

comorbidity, malignant neoplasm

Data type

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.
Description

pregnancy, contraceptive methods

Data type

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.
Description

no other serious medical or psychiatric illness

Data type

boolean

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

Eligibility Colorectal Cancer NCT00271011

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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