ID

16775

Description

Phase I/II CT 2106 and 5-FU/FA in Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00291785

Link

https://clinicaltrials.gov/show/NCT00291785

Keywords

Versions (1)
  1. 8/6/16 8/6/16 -
Uploaded on

August 6, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00291785

English

Eligibility Colorectal Cancer NCT00291785

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven metastatic colorectal adenocarcinoma, failing one prior treatment containing oxaliplatin plus 5-fu/fa
Description

Adenocarcinoma of large intestine metastatic | Prior Therapy failed | oxaliplatin | Fluorouracil | Folic Acid

Data type

boolean

Alias
UMLS CUI [1,1]
C1319315
UMLS CUI [1,2]
C1522484
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0231175
UMLS CUI [3]
C0069717
UMLS CUI [4]
C0016360
UMLS CUI [5]
C0016410
at least one measurable lesion according to recist criteria for both phase i and ii
Description

Measurable Disease Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
ecog performance status 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematologic, renal and hepatic function
Description

Hematologic function | Renal function | Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
wash out period of at least 4 weeks from surgery, 4 weeks from radiotherapy
Description

Washout Period | Operative Surgical Procedures | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1710661
UMLS CUI [2]
C0543467
UMLS CUI [3]
C1522449
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
past or concurrent history of neoplasm other than colorectal adenocarcinoma, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix.
Description

Malignant Neoplasms | Adenocarcinoma of large intestine | curative treatment Skin carcinoma | curative treatment Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C1319315
UMLS CUI [3,1]
C1273390
UMLS CUI [3,2]
C0699893
UMLS CUI [4,1]
C1273390
UMLS CUI [4,2]
C0851140
pregnant or lactating patients
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
prior treatment with camptothecins
Description

Camptothecin

Data type

boolean

Alias
UMLS CUI [1]
C0006812
presence or history of cns metastasis or carcinomatous leptomeningitis
Description

CNS metastases | Meningeal Carcinomatosis

Data type

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0220654
current active infection per investigator assessment
Description

Communicable Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0009450
unresolved bowel obstruction or partial obstruction, uncontrolled crohn's disease or ulcerative colitis
Description

Intestinal Obstruction Unresolved | Partial bowel obstruction | Crohn Disease Uncontrolled | Ulcerative Colitis Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0021843
UMLS CUI [1,2]
C0443342
UMLS CUI [2]
C1328480
UMLS CUI [3,1]
C0010346
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0009324
UMLS CUI [4,2]
C0205318
current history of chronic diarrhea greater than or equal to grade 1 (ctcae version 3)
Description

Chronic diarrhea | CTCAE

Data type

boolean

Alias
UMLS CUI [1]
C0401151
UMLS CUI [2]
C1516728
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Similar models

Eligibility Colorectal Cancer NCT00291785

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of large intestine metastatic | Prior Therapy failed | oxaliplatin | Fluorouracil | Folic Acid
Item
histologically proven metastatic colorectal adenocarcinoma, failing one prior treatment containing oxaliplatin plus 5-fu/fa
boolean
C1319315 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0069717 (UMLS CUI [3])
C0016360 (UMLS CUI [4])
C0016410 (UMLS CUI [5])
Measurable Disease Quantity
Item
at least one measurable lesion according to recist criteria for both phase i and ii
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
ECOG performance status
Item
ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Renal function | Liver function
Item
adequate hematologic, renal and hepatic function
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Washout Period | Operative Surgical Procedures | Therapeutic radiology procedure
Item
wash out period of at least 4 weeks from surgery, 4 weeks from radiotherapy
boolean
C1710661 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Adenocarcinoma of large intestine | curative treatment Skin carcinoma | curative treatment Carcinoma in situ of uterine cervix
Item
past or concurrent history of neoplasm other than colorectal adenocarcinoma, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix.
boolean
C0006826 (UMLS CUI [1])
C1319315 (UMLS CUI [2])
C1273390 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1273390 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating patients
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Camptothecin
Item
prior treatment with camptothecins
boolean
C0006812 (UMLS CUI [1])
CNS metastases | Meningeal Carcinomatosis
Item
presence or history of cns metastasis or carcinomatous leptomeningitis
boolean
C0686377 (UMLS CUI [1])
C0220654 (UMLS CUI [2])
Communicable Diseases
Item
current active infection per investigator assessment
boolean
C0009450 (UMLS CUI [1])
Intestinal Obstruction Unresolved | Partial bowel obstruction | Crohn Disease Uncontrolled | Ulcerative Colitis Uncontrolled
Item
unresolved bowel obstruction or partial obstruction, uncontrolled crohn's disease or ulcerative colitis
boolean
C0021843 (UMLS CUI [1,1])
C0443342 (UMLS CUI [1,2])
C1328480 (UMLS CUI [2])
C0010346 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0009324 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Chronic diarrhea | CTCAE
Item
current history of chronic diarrhea greater than or equal to grade 1 (ctcae version 3)
boolean
C0401151 (UMLS CUI [1])
C1516728 (UMLS CUI [2])
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