ID

20213

Description

A Phase I Study of S-1 Plus Irinotecan and Oxaliplatin in Advanced Gastrointestinal Malignancy; ODM derived from: https://clinicaltrials.gov/show/NCT00506207

Link

https://clinicaltrials.gov/show/NCT00506207

Keywords

Versions (1)
  1. 2/13/17 2/13/17 -
Uploaded on

February 13, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Neoplasm NCT00506207

English

Eligibility Colorectal Neoplasm NCT00506207

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed unresectable or metastatic colorectal or gastric carcinoma
Description

Colorectal Carcinoma unresectable | Colorectal Carcinoma metastatic | Stomach Carcinoma unresectable | Stomach Carcinoma metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C1519810
UMLS CUI [2,1]
C0009402
UMLS CUI [2,2]
C1522484
UMLS CUI [3,1]
C0699791
UMLS CUI [3,2]
C1519810
UMLS CUI [4,1]
C0699791
UMLS CUI [4,2]
C1522484
eastern cooperative oncology group (ecog) performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
measurable disease, according to the recist criteria or non-measurable disease measurable lesions
Description

Measurable Disease | Disease Non-Measurable Measurable lesion

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1518373
UMLS CUI [2,3]
C1513041
previous adjuvant, palliative chemotherapy including 5-fu, oxaliplatin and irinotecan, molecular targeted therapy and/or radiotherapy is allowed
Description

Adjuvant Chemotherapy Palliative | Fluorouracil | oxaliplatin | irinotecan | Molecular Targeted Therapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C1285530
UMLS CUI [2]
C0016360
UMLS CUI [3]
C0069717
UMLS CUI [4]
C0123931
UMLS CUI [5]
C2699893
UMLS CUI [6]
C1522449
adequate major organ functions
Description

Organ function Major

Data type

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0205164
patients should sign a written informed consent before study entry
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior history of peripheral neuropathy
Description

Peripheral Neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0031117
inadequate cardiovascular
Description

Abnormal cardiovascular function

Data type

boolean

Alias
UMLS CUI [1]
C0232090
serious concurrent infection or nonmalignant illness
Description

Communicable Disease Serious | Illness Non-Malignant

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C1518371
other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix
Description

Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0851140
psychiatric disorder that would preclude compliance
Description

Mental disorder Compliance behavior Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C2828389
pregnant, nursing women or patients with reproductive potential without contraception
Description

Pregnancy | Breast Feeding | Females & males of reproductive potential Without Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C4034483
UMLS CUI [3,2]
C0332288
UMLS CUI [3,3]
C0700589
patients receiving a concomitant treatment with drugs interacting with s-1 such as flucytosine, phenytoin, or warfarin et al.
Description

Pharmaceutical Preparations Interaction S-1 | Flucytosine | Phenytoin | Warfarin

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0687133
UMLS CUI [1,3]
C0879262
UMLS CUI [2]
C0016278
UMLS CUI [3]
C0031507
UMLS CUI [4]
C0043031
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Similar models

Eligibility Colorectal Neoplasm NCT00506207

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma unresectable | Colorectal Carcinoma metastatic | Stomach Carcinoma unresectable | Stomach Carcinoma metastatic
Item
histologically or cytologically confirmed unresectable or metastatic colorectal or gastric carcinoma
boolean
C0009402 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0009402 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C0699791 (UMLS CUI [3,1])
C1519810 (UMLS CUI [3,2])
C0699791 (UMLS CUI [4,1])
C1522484 (UMLS CUI [4,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Measurable Disease | Disease Non-Measurable Measurable lesion
Item
measurable disease, according to the recist criteria or non-measurable disease measurable lesions
boolean
C1513041 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C1518373 (UMLS CUI [2,2])
C1513041 (UMLS CUI [2,3])
Adjuvant Chemotherapy Palliative | Fluorouracil | oxaliplatin | irinotecan | Molecular Targeted Therapy | Therapeutic radiology procedure
Item
previous adjuvant, palliative chemotherapy including 5-fu, oxaliplatin and irinotecan, molecular targeted therapy and/or radiotherapy is allowed
boolean
C0085533 (UMLS CUI [1,1])
C1285530 (UMLS CUI [1,2])
C0016360 (UMLS CUI [2])
C0069717 (UMLS CUI [3])
C0123931 (UMLS CUI [4])
C2699893 (UMLS CUI [5])
C1522449 (UMLS CUI [6])
Organ function Major
Item
adequate major organ functions
boolean
C0678852 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Informed Consent
Item
patients should sign a written informed consent before study entry
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Peripheral Neuropathy
Item
prior history of peripheral neuropathy
boolean
C0031117 (UMLS CUI [1])
Abnormal cardiovascular function
Item
inadequate cardiovascular
boolean
C0232090 (UMLS CUI [1])
Communicable Disease Serious | Illness Non-Malignant
Item
serious concurrent infection or nonmalignant illness
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C1518371 (UMLS CUI [2,2])
Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix
Item
other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
Mental disorder Compliance behavior Excluded
Item
psychiatric disorder that would preclude compliance
boolean
C0004936 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Females & males of reproductive potential Without Contraceptive methods
Item
pregnant, nursing women or patients with reproductive potential without contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C4034483 (UMLS CUI [3,1])
C0332288 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
Pharmaceutical Preparations Interaction S-1 | Flucytosine | Phenytoin | Warfarin
Item
patients receiving a concomitant treatment with drugs interacting with s-1 such as flucytosine, phenytoin, or warfarin et al.
boolean
C0013227 (UMLS CUI [1,1])
C0687133 (UMLS CUI [1,2])
C0879262 (UMLS CUI [1,3])
C0016278 (UMLS CUI [2])
C0031507 (UMLS CUI [3])
C0043031 (UMLS CUI [4])
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