ID

20213

Beschreibung

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

Stichworte

  1. 13.02.17 13.02.17 -
Hochgeladen am

13. Februar 2017

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Colorectal Neoplasm NCT00506207

Eligibility Colorectal Neoplasm NCT00506207

Inclusion Criteria
Beschreibung

Inclusion Criteria

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

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

Datentyp

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
Beschreibung

ECOG performance status

Datentyp

boolean

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

Measurable Disease | Disease Non-Measurable Measurable lesion

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Organ function Major

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior history of peripheral neuropathy
Beschreibung

Peripheral Neuropathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0031117
inadequate cardiovascular
Beschreibung

Abnormal cardiovascular function

Datentyp

boolean

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

Communicable Disease Serious | Illness Non-Malignant

Datentyp

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
Beschreibung

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

Datentyp

boolean

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

Mental disorder Compliance behavior Excluded

Datentyp

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
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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

Ähnliche Modelle

Eligibility Colorectal Neoplasm NCT00506207

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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