ID

27756

Description

Adjuvant Cisplatin Plus Gemcitabine in Operable Cholangiocellular Carcinoma.; ODM derived from: https://clinicaltrials.gov/show/NCT01073839

Lien

https://clinicaltrials.gov/show/NCT01073839

Mots-clés

Versions (1)
  1. 28/11/2017 28/11/2017 -
Détendeur de droits

See clinicaltrials.gov

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28 novembre 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Cholangiocellular Carcinoma NCT01073839

Anglais

Eligibility Cholangiocellular Carcinoma NCT01073839

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic and hilar tumors). carcinomas involving the gall bladder are allowed.
Description

Adenocarcinoma Biliary tract | Neoplasms intrahepatic | Neoplasms Hilar | Carcinoma Involving Gallbladder

Type de données

boolean

Alias
UMLS CUI [1,1]
C0001418
UMLS CUI [1,2]
C0005423
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1512948
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C0205150
UMLS CUI [4,1]
C0007097
UMLS CUI [4,2]
C1314939
UMLS CUI [4,3]
C0016976
2. macroscopically complete resection within 8 weeks before start of chemotherapy.
Description

Complete excision macroscopic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0015250
UMLS CUI [1,2]
C0439806
3. written informed consent.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
4. health status: who performance status (ps) 0-1
Description

WHO performance status scale

Type de données

boolean

Alias
UMLS CUI [1]
C1298650
5. age >18 years
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
6. adequate renal function (creatinine clearance ≥ 60 ml/min, calculated according to the formula of cockcroft-gault)
Description

Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula

Type de données

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C2711451
7. adequate hepatic function (bilirubin ≤ 3 x lun, ap ≤ 5 x lun, asat ≤ 5 x lun)
Description

Liver function | Serum total bilirubin measurement | Alkaline phosphatase measurement | Aspartate aminotransferase measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201850
UMLS CUI [4]
C0201899
8. adequate hematologic function: neutrophils ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, hb
Description

Hematologic function | Neutrophil count | Platelet Count measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0032181
≥ 9,5 mg/dl
Description

Hemoglobin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0518015
9. patient compliance and geographic proximity allowing proper staging, treatment and follow-up.
Description

Compliance behavior allowing TNM clinical staging | Proximity Geographic allowing TNM clinical staging | Compliance behavior allowing Therapeutic procedure | Proximity Geographic allowing Therapeutic procedure | Compliance behavior allowing Follow-up | Proximity Geographic allowing Follow-up

Type de données

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0683607
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C1514583
UMLS CUI [2,2]
C1517526
UMLS CUI [2,3]
C0683607
UMLS CUI [2,4]
C3258246
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0683607
UMLS CUI [3,3]
C0087111
UMLS CUI [4,1]
C1514583
UMLS CUI [4,2]
C1517526
UMLS CUI [4,3]
C0683607
UMLS CUI [4,4]
C0087111
UMLS CUI [5,1]
C1321605
UMLS CUI [5,2]
C0683607
UMLS CUI [5,3]
C3274571
UMLS CUI [6,1]
C1514583
UMLS CUI [6,2]
C1517526
UMLS CUI [6,3]
C0683607
UMLS CUI [6,4]
C3274571
10. women who are not breastfeeding and are using effective contraception if sexually active, who are not pregnant and agree not to become pregnant during participation in the trial or during the 12 months thereafter. a negative pregnancy test before inclusion into the trial is required for women < 50 years. men who agree not to father a child during participation in the trial or during the 12 months thereafter.
Description

Gender Breast Feeding Absent | Gender Sexually active Contraceptive methods | Pregnancy Absent | Planned Pregnancy Unwilling | Gender Age Pregnancy test negative | Gender Reproduction Unwilling

Type de données

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0006147
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0700589
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0032992
UMLS CUI [4,2]
C0558080
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0001779
UMLS CUI [5,3]
C0427780
UMLS CUI [6,1]
C0079399
UMLS CUI [6,2]
C0035150
UMLS CUI [6,3]
C0558080
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnancy or breastfeeding women
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. previous malignancy within 5 years or concomitant malignancy, except: non-melanomatous skin cancer or adequately treated in situ cervical cancer
Description

Cancer Other | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix Treated

Type de données

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1522326
3. neutrophils < 1.5 x 109/l, platelets < 100 x 109/l, hb < 9,5 mg/dl
Description

Neutrophil count | Platelet Count measurement | Hemoglobin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
4. bilirubin > 3 x lun, alat > 5 x lun, asat > 5 x lun
Description

Elevated total bilirubin | Alanine aminotransferase increased | Aspartate aminotransferase increased

Type de données

boolean

Alias
UMLS CUI [1]
C0741494
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
5. creatinine clearance < 60 ml/min, calculated according to the formula of cockcroft-gault
Description

Estimation of creatinine clearance by Cockcroft-Gault formula

Type de données

boolean

Alias
UMLS CUI [1]
C2711451
6. prior chemotherapy with gemcitabine
Description

Prior Chemotherapy | gemcitabine

Type de données

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0045093
7. severe or uncontrolled cardiovascular disease (congestive heart failure nyha iii or iv, unstable angina pectoris, history of myocardial infarction in the last 3 months, significant arrhythmias)
Description

Cardiovascular Disease Severe | Cardiovascular Disease Uncontrolled | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction | Cardiac Arrhythmia

Type de données

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C1275491
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0027051
UMLS CUI [6]
C0003811
8. psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
Description

Mental disorders Exclude Comprehension Study Protocol | Mental disorders Exclude Informed Consent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C2348563
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0021430
9. active uncontrolled infection
Description

Communicable Disease Uncontrolled

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
10. preexisting peripheral neuropathy (> grade 1)
Description

Peripheral Neuropathy Pre-existing CTCAE Grades

Type de données

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
11. serious underlying medical condition (judged by the investigator) which could impair the ability of the patient to participate in the trial (e.g. uncontrolled diabetes mellitus, active autoimmune disease)
Description

Comorbidity Serious Study Subject Participation Status Impaired | Diabetic - poor control | Autoimmune Diseases

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C0221099
UMLS CUI [2]
C0421258
UMLS CUI [3]
C0004364
12. concurrent treatment with other experimental drugs or other anti-cancer therapy; treatment in a clinical trial within 30 days prior to trial entry
Description

Investigational New Drugs | Cancer treatment | Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0920425
UMLS CUI [3]
C2348568
13. known hypersensitivity to the study drugs
Description

Hypersensitivity Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
Retour au début de la page

Similar models

Eligibility Cholangiocellular Carcinoma NCT01073839

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma Biliary tract | Neoplasms intrahepatic | Neoplasms Hilar | Carcinoma Involving Gallbladder
Item
1. histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic and hilar tumors). carcinomas involving the gall bladder are allowed.
boolean
C0001418 (UMLS CUI [1,1])
C0005423 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C1512948 (UMLS CUI [2,2])
C0027651 (UMLS CUI [3,1])
C0205150 (UMLS CUI [3,2])
C0007097 (UMLS CUI [4,1])
C1314939 (UMLS CUI [4,2])
C0016976 (UMLS CUI [4,3])
Complete excision macroscopic
Item
2. macroscopically complete resection within 8 weeks before start of chemotherapy.
boolean
C0015250 (UMLS CUI [1,1])
C0439806 (UMLS CUI [1,2])
Informed Consent
Item
3. written informed consent.
boolean
C0021430 (UMLS CUI [1])
WHO performance status scale
Item
4. health status: who performance status (ps) 0-1
boolean
C1298650 (UMLS CUI [1])
Age
Item
5. age >18 years
boolean
C0001779 (UMLS CUI [1])
Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
6. adequate renal function (creatinine clearance ≥ 60 ml/min, calculated according to the formula of cockcroft-gault)
boolean
C0232804 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Liver function | Serum total bilirubin measurement | Alkaline phosphatase measurement | Aspartate aminotransferase measurement
Item
7. adequate hepatic function (bilirubin ≤ 3 x lun, ap ≤ 5 x lun, asat ≤ 5 x lun)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
Hematologic function | Neutrophil count | Platelet Count measurement
Item
8. adequate hematologic function: neutrophils ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, hb
boolean
C0221130 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Hemoglobin measurement
Item
≥ 9,5 mg/dl
boolean
C0518015 (UMLS CUI [1])
Compliance behavior allowing TNM clinical staging | Proximity Geographic allowing TNM clinical staging | Compliance behavior allowing Therapeutic procedure | Proximity Geographic allowing Therapeutic procedure | Compliance behavior allowing Follow-up | Proximity Geographic allowing Follow-up
Item
9. patient compliance and geographic proximity allowing proper staging, treatment and follow-up.
boolean
C1321605 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C1514583 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C3258246 (UMLS CUI [2,4])
C1321605 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C1514583 (UMLS CUI [4,1])
C1517526 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
C0087111 (UMLS CUI [4,4])
C1321605 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C3274571 (UMLS CUI [5,3])
C1514583 (UMLS CUI [6,1])
C1517526 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
C3274571 (UMLS CUI [6,4])
Gender Breast Feeding Absent | Gender Sexually active Contraceptive methods | Pregnancy Absent | Planned Pregnancy Unwilling | Gender Age Pregnancy test negative | Gender Reproduction Unwilling
Item
10. women who are not breastfeeding and are using effective contraception if sexually active, who are not pregnant and agree not to become pregnant during participation in the trial or during the 12 months thereafter. a negative pregnancy test before inclusion into the trial is required for women < 50 years. men who agree not to father a child during participation in the trial or during the 12 months thereafter.
boolean
C0079399 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0032961 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0032992 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
C0079399 (UMLS CUI [5,1])
C0001779 (UMLS CUI [5,2])
C0427780 (UMLS CUI [5,3])
C0079399 (UMLS CUI [6,1])
C0035150 (UMLS CUI [6,2])
C0558080 (UMLS CUI [6,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. pregnancy or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cancer Other | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix Treated
Item
2. previous malignancy within 5 years or concomitant malignancy, except: non-melanomatous skin cancer or adequately treated in situ cervical cancer
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
Neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
3. neutrophils < 1.5 x 109/l, platelets < 100 x 109/l, hb < 9,5 mg/dl
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Elevated total bilirubin | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
4. bilirubin > 3 x lun, alat > 5 x lun, asat > 5 x lun
boolean
C0741494 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
5. creatinine clearance < 60 ml/min, calculated according to the formula of cockcroft-gault
boolean
C2711451 (UMLS CUI [1])
Prior Chemotherapy | gemcitabine
Item
6. prior chemotherapy with gemcitabine
boolean
C1514457 (UMLS CUI [1])
C0045093 (UMLS CUI [2])
Cardiovascular Disease Severe | Cardiovascular Disease Uncontrolled | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction | Cardiac Arrhythmia
Item
7. severe or uncontrolled cardiovascular disease (congestive heart failure nyha iii or iv, unstable angina pectoris, history of myocardial infarction in the last 3 months, significant arrhythmias)
boolean
C0007222 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0003811 (UMLS CUI [6])
Mental disorders Exclude Comprehension Study Protocol | Mental disorders Exclude Informed Consent
Item
8. psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
Communicable Disease Uncontrolled
Item
9. active uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Peripheral Neuropathy Pre-existing CTCAE Grades
Item
10. preexisting peripheral neuropathy (> grade 1)
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Comorbidity Serious Study Subject Participation Status Impaired | Diabetic - poor control | Autoimmune Diseases
Item
11. serious underlying medical condition (judged by the investigator) which could impair the ability of the patient to participate in the trial (e.g. uncontrolled diabetes mellitus, active autoimmune disease)
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0221099 (UMLS CUI [1,4])
C0421258 (UMLS CUI [2])
C0004364 (UMLS CUI [3])
Investigational New Drugs | Cancer treatment | Study Subject Participation Status
Item
12. concurrent treatment with other experimental drugs or other anti-cancer therapy; treatment in a clinical trial within 30 days prior to trial entry
boolean
C0013230 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C2348568 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs
Item
13. known hypersensitivity to the study drugs
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
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