ID

35922

Description

This is a multicentre, two stage, prospective, randomized, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. standard of care (capecitabine) and observation in patients after curative intent resection of cholangiocarcinoma and muscle invasive gall bladder carcinoma. ODM derived from: https://clinicaltrials.gov/show/NCT02170090

Link

https://clinicaltrials.gov/show/NCT02170090

Keywords

Versions (1)
  1. 4/4/19 4/4/19 -
Copyright Holder

Universitätsklinikum Hamburg-Eppendorf

Uploaded on

April 4, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Adjuvant Chemotherapy with Gemcitabin and Cisplatin Compared to Standard of Care After Resection of Biliary Tract Cancer NCT02170090

English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Criteria for initial study enrollment
Description

Criteria for initial study enrollment

Alias
UMLS CUI-1
C0243161
UMLS CUI-2
C4041024
Patient didn't have prior chemotherapy for cholangiocarcinoma
Description

Prior chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0206698
UMLS CUI [1,3]
C0332197
Patient had no previous malignancy within 3 years or concomitant malignancy, except: non-melanomatous skin cancer or adequately treated in situ cervical cancer
Description

Other malignant neoplasia

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C0521115
UMLS CUI [1,4]
C0332197
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C0006826
UMLS CUI [2,3]
C0332185
UMLS CUI [2,4]
C0332197
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C1518408
UMLS CUI [3,3]
C0007114
UMLS CUI [4,1]
C0332300
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
Patient has no 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 arrhythmia)
Description

Cardiovascular disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C1275491
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0002965
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C1275835
UMLS CUI [5,2]
C0332185
UMLS CUI [5,3]
C0332197
UMLS CUI [6,1]
C0003811
UMLS CUI [6,2]
C0750502
UMLS CUI [6,3]
C0332197
Patient has no psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
Description

Psychiatric disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0582778
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0021430
Patient has no serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial
Description

Medical conditions

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C1299582
UMLS CUI [1,4]
C2348568
Fertile women (< 1 year after last menstruation) and procreative men willing and able to use effective means of contraception
Description

oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0085732
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0600109
Patient is not pregnant or breastfeeding
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C0008976
Histologically confirmed adenocarcinoma of biliary tract (intrahepatic, hilar or extrahepatic cholangicarcinoma or muscle invasive gallbladder carcinoma) after radical surgical therapy with macroscopically complete resection (mixed tumor entities (hcc/cca) are excluded)
Description

Diagnosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0001418
UMLS CUI [1,2]
C0005423
UMLS CUI [1,3]
C0679557
UMLS CUI [1,4]
C0279651
UMLS CUI [1,5]
C0205281
UMLS CUI [2,1]
C0015250
UMLS CUI [2,2]
C1551402
Patient aged >18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Patient has gotten macroscopically complete resection (r0/1) within 6 (-16) weeks before scheduled start of chemotherapy
Description

Complete resection of tumor

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0015250
UMLS CUI [1,3]
C0332185
Patient has an ECOG between 0-1
Description

Impairment of quality of life

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Patient with an adequate hematologic function
Description

Hematologic function

Data type

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0205411
Patient with an adequate liver function
Description

Liver function

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0205411
Patient with an adequate renal function
Description

Renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0205411
Patient has no active uncontrolled infection, except chronic viral hepatitis under antiviral therapy
Description

Infection

Data type

boolean

Alias
UMLS CUI [1,1]
C3714514
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0205177
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C0042721
UMLS CUI [2,3]
C0280274
Patient has no concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to randomization
Description

Other treatments

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C2348568
UMLS CUI [3,2]
C1705242
UMLS CUI [3,3]
C0332185
UMLS CUI [3,4]
C0332197
Patient has a negative serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women <1 year after the onset of menopause
Description

a negative test has to be reconfirmed by a urine test, should the 7-day window be exceeded

Data type

boolean

Alias
UMLS CUI [1]
C0427780
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C0243161 (UMLS CUI-1)
C4041024 (UMLS CUI-2)
Prior chemotherapy
Item
Patient didn't have prior chemotherapy for cholangiocarcinoma
boolean
C1514457 (UMLS CUI [1,1])
C0206698 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Other malignant neoplasia
Item
Patient had no previous malignancy within 3 years or concomitant malignancy, except: non-melanomatous skin cancer or adequately treated in situ cervical cancer
boolean
C0205394 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0521115 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
C0332300 (UMLS CUI [3,1])
C1518408 (UMLS CUI [3,2])
C0007114 (UMLS CUI [3,3])
C0332300 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Cardiovascular disease
Item
Patient has no 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 arrhythmia)
boolean
C0007222 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0007222 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0018802 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0002965 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1275835 (UMLS CUI [5,1])
C0332185 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0003811 (UMLS CUI [6,1])
C0750502 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
Psychiatric disorders
Item
Patient has no psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
boolean
C0004936 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0582778 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
Medical conditions
Item
Patient has no serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial
boolean
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
Contraception
Item
Fertile women (< 1 year after last menstruation) and procreative men willing and able to use effective means of contraception
boolean
C0700589 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Pregnancy
Item
Patient is not pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C1512693 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Diagnosis
Item
Histologically confirmed adenocarcinoma of biliary tract (intrahepatic, hilar or extrahepatic cholangicarcinoma or muscle invasive gallbladder carcinoma) after radical surgical therapy with macroscopically complete resection (mixed tumor entities (hcc/cca) are excluded)
boolean
C0001418 (UMLS CUI [1,1])
C0005423 (UMLS CUI [1,2])
C0679557 (UMLS CUI [1,3])
C0279651 (UMLS CUI [1,4])
C0205281 (UMLS CUI [1,5])
C0015250 (UMLS CUI [2,1])
C1551402 (UMLS CUI [2,2])
Age
Item
Patient aged >18 years
boolean
C0001779 (UMLS CUI [1])
Complete resection of tumor
Item
Patient has gotten macroscopically complete resection (r0/1) within 6 (-16) weeks before scheduled start of chemotherapy
boolean
C0006826 (UMLS CUI [1,1])
C0015250 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Impairment of quality of life
Item
Patient has an ECOG between 0-1
boolean
C1520224 (UMLS CUI [1])
Hematologic function
Item
Patient with an adequate hematologic function
boolean
C0221130 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
Liver function
Item
Patient with an adequate liver function
boolean
C0232741 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
Renal function
Item
Patient with an adequate renal function
boolean
C0232804 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
Infection
Item
Patient has no active uncontrolled infection, except chronic viral hepatitis under antiviral therapy
boolean
C3714514 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,3])
C0332300 (UMLS CUI [2,1])
C0042721 (UMLS CUI [2,2])
C0280274 (UMLS CUI [2,3])
Other treatments
Item
Patient has no concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to randomization
boolean
C0304229 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0920425 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C2348568 (UMLS CUI [3,1])
C1705242 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
C0332197 (UMLS CUI [3,4])
Pregnancy
Item
Patient has a negative serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women <1 year after the onset of menopause
boolean
C0427780 (UMLS CUI [1])
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