ID

35471

Description

Modufolin® in Combination With 5-Fluorouracil Alone or Together With Oxaliplatin or Irinotecan in Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02244632

Link

https://clinicaltrials.gov/show/NCT02244632

Keywords

Versions (1)
  1. 3/5/19 3/5/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 5, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Neoplasm NCT02244632

English

Eligibility Colorectal Neoplasm NCT02244632

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. advanced metastatic colorectal (stage iv) cancer verified by biopsy
Description

Colorectal cancer metastatic Advanced Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0948380
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0005558
2. ct-scan or mri of thorax, abdomen and pelvis; within four (< 4) weeks before start of chemotherapy
Description

Chest CT | MRI of Chest | CT of abdomen | MRI of abdomen | CT of Pelvis | MRI of Pelvis

Data type

boolean

Alias
UMLS CUI [1]
C0202823
UMLS CUI [2]
C0202826
UMLS CUI [3]
C0412620
UMLS CUI [4]
C0412693
UMLS CUI [5]
C0412628
UMLS CUI [6]
C0203201
3. evaluable disease and one measurable site of disease according to recist 1.1 criteria (at least 10 mm for ct-scan or mri)
Description

Evaluable Disease | Measurable Disease Site Quantity | Site Size CT scan | Site Size MRI scan

Data type

boolean

Alias
UMLS CUI [1]
C1516986
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1515974
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C1515974
UMLS CUI [3,2]
C0456389
UMLS CUI [3,3]
C0040405
UMLS CUI [4,1]
C1515974
UMLS CUI [4,2]
C0456389
UMLS CUI [4,3]
C0024485
4. male and female adults, age of 18 years or older
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
5. who performance status 0 < 2, and life expectancy > 3 months
Description

WHO performance status scale | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C1298650
UMLS CUI [2]
C0023671
6. adequate haematological function:
Description

Hematologic function

Data type

boolean

Alias
UMLS CUI [1]
C0221130
1. haemoglobin (hb) > 100 g/l,
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
2. absolute neutrophil count (anc) > 1.5x109/l, and
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
3. platelets > 100x109/l
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
7. adequate renal and hepatic functions:
Description

Renal function | Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
1. creatinine clearance > 50 ml/min,
Description

Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0373595
2. total bilirubin < 1.5 times upper limit of normal (uln),
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
3. aspartate transaminase (ast) and alanine transaminase (alt) < 3 times uln (and < 5 times uln in case of liver metastases)
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0494165
8. negative pregnancy test for females of child bearing potential
Description

Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
9. willing and able to provide informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
10. using adequate contraceptive measures
Description

Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. tumours other than colorectal adenocarcinomas (current or within the previous 5 years), with the exception for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1319315
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0851140
2. adjuvant treatment of crc within the last 12 months.
Description

Adjuvant therapy Colorectal Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0677850
UMLS CUI [1,2]
C0009402
3. evidence of central nervous system metastases
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
4. unresolved bowel obstruction or sub-obstruction, uncontrolled crohn's disease or ulcerative colitis
Description

Resolution Lacking Intestinal Obstruction | Crohn Disease Uncontrolled | Ulcerative Colitis

Data type

boolean

Alias
UMLS CUI [1,1]
C1514893
UMLS CUI [1,2]
C0332268
UMLS CUI [1,3]
C0021843
UMLS CUI [2,1]
C0010346
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0009324
5. history of cardiac disease with a new your heart association (nyha) class ii or greater congestive heart failure, myocardial infarction or unstable angina in the past six (6) months prior to day 1 of treatment and serious arrhythmias requiring medication for treatment
Description

Heart Disease | Congestive heart failure New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | Cardiac Arrhythmia Serious Requirement Pharmacotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C0205404
UMLS CUI [5,3]
C1514873
UMLS CUI [5,4]
C0013216
6. current severe chronic diarrhoea
Description

Diarrhea, severe, chronic

Data type

boolean

Alias
UMLS CUI [1]
C1847423
7. current chronic infection or uncontrolled serious illness causing immunodeficiency
Description

Chronic infectious disease | Illness Serious Uncontrolled | Is etiology for Immunodeficiency

Data type

boolean

Alias
UMLS CUI [1]
C0151317
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0205318
UMLS CUI [3,1]
C1562189
UMLS CUI [3,2]
C0021051
8. any current uncontrolled serious illness or medical condition
Description

Illness Serious Uncontrolled | Medical condition Serious Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0205318
9. current major psychiatric disorder (e.g. major depression, psychosis)
Description

Major psychiatric illness | Major Depressive Disorder | Psychotic Disorder Major

Data type

boolean

Alias
UMLS CUI [1]
C4534351
UMLS CUI [2]
C1269683
UMLS CUI [3,1]
C0033975
UMLS CUI [3,2]
C0205164
10. participation in another clinical study with an imp within one (1) month prior to inclusion
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
11. known intolerance to fluoropyrimidine therapy suggestive of dihydropyrimidine dehydrogenase deficiency
Description

Intolerance to Fluoropyrimidine | Suggestive of Dihydropyrimidine Dehydrogenase Deficiency

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0596581
UMLS CUI [2,1]
C0332299
UMLS CUI [2,2]
C1959620
12. suspicion of hypersensitivity or allergy to the imp, or to products chemically related to the imp (i.e. folate derivatives)
Description

Suspicion Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Investigational New Drugs Related | Hypersensitivity Folate Derivative

Data type

boolean

Alias
UMLS CUI [1,1]
C0242114
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0013230
UMLS CUI [2,4]
C0439849
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0178638
UMLS CUI [3,3]
C1527240
13. female patients: currently pregnant or breast-feeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Colorectal Neoplasm NCT02244632

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal cancer metastatic Advanced Biopsy
Item
1. advanced metastatic colorectal (stage iv) cancer verified by biopsy
boolean
C0948380 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
Chest CT | MRI of Chest | CT of abdomen | MRI of abdomen | CT of Pelvis | MRI of Pelvis
Item
2. ct-scan or mri of thorax, abdomen and pelvis; within four (< 4) weeks before start of chemotherapy
boolean
C0202823 (UMLS CUI [1])
C0202826 (UMLS CUI [2])
C0412620 (UMLS CUI [3])
C0412693 (UMLS CUI [4])
C0412628 (UMLS CUI [5])
C0203201 (UMLS CUI [6])
Evaluable Disease | Measurable Disease Site Quantity | Site Size CT scan | Site Size MRI scan
Item
3. evaluable disease and one measurable site of disease according to recist 1.1 criteria (at least 10 mm for ct-scan or mri)
boolean
C1516986 (UMLS CUI [1])
C1513041 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1515974 (UMLS CUI [3,1])
C0456389 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C1515974 (UMLS CUI [4,1])
C0456389 (UMLS CUI [4,2])
C0024485 (UMLS CUI [4,3])
Adult | Age
Item
4. male and female adults, age of 18 years or older
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
WHO performance status scale | Life Expectancy
Item
5. who performance status 0 < 2, and life expectancy > 3 months
boolean
C1298650 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Hematologic function
Item
6. adequate haematological function:
boolean
C0221130 (UMLS CUI [1])
Hemoglobin measurement
Item
1. haemoglobin (hb) > 100 g/l,
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count
Item
2. absolute neutrophil count (anc) > 1.5x109/l, and
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
3. platelets > 100x109/l
boolean
C0032181 (UMLS CUI [1])
Renal function | Liver function
Item
7. adequate renal and hepatic functions:
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
Creatinine clearance measurement
Item
1. creatinine clearance > 50 ml/min,
boolean
C0373595 (UMLS CUI [1])
Serum total bilirubin measurement
Item
2. total bilirubin < 1.5 times upper limit of normal (uln),
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver
Item
3. aspartate transaminase (ast) and alanine transaminase (alt) < 3 times uln (and < 5 times uln in case of liver metastases)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
Childbearing Potential Pregnancy test negative
Item
8. negative pregnancy test for females of child bearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Informed Consent
Item
9. willing and able to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Contraceptive methods
Item
10. using adequate contraceptive measures
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Exception Adenocarcinoma of large intestine | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix
Item
1. tumours other than colorectal adenocarcinomas (current or within the previous 5 years), with the exception for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1319315 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0699893 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0851140 (UMLS CUI [4,3])
Adjuvant therapy Colorectal Carcinoma
Item
2. adjuvant treatment of crc within the last 12 months.
boolean
C0677850 (UMLS CUI [1,1])
C0009402 (UMLS CUI [1,2])
CNS metastases
Item
3. evidence of central nervous system metastases
boolean
C0686377 (UMLS CUI [1])
Resolution Lacking Intestinal Obstruction | Crohn Disease Uncontrolled | Ulcerative Colitis
Item
4. unresolved bowel obstruction or sub-obstruction, uncontrolled crohn's disease or ulcerative colitis
boolean
C1514893 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0021843 (UMLS CUI [1,3])
C0010346 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0009324 (UMLS CUI [3])
Heart Disease | Congestive heart failure New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | Cardiac Arrhythmia Serious Requirement Pharmacotherapy
Item
5. history of cardiac disease with a new your heart association (nyha) class ii or greater congestive heart failure, myocardial infarction or unstable angina in the past six (6) months prior to day 1 of treatment and serious arrhythmias requiring medication for treatment
boolean
C0018799 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C1514873 (UMLS CUI [5,3])
C0013216 (UMLS CUI [5,4])
Diarrhea, severe, chronic
Item
6. current severe chronic diarrhoea
boolean
C1847423 (UMLS CUI [1])
Chronic infectious disease | Illness Serious Uncontrolled | Is etiology for Immunodeficiency
Item
7. current chronic infection or uncontrolled serious illness causing immunodeficiency
boolean
C0151317 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C1562189 (UMLS CUI [3,1])
C0021051 (UMLS CUI [3,2])
Illness Serious Uncontrolled | Medical condition Serious Uncontrolled
Item
8. any current uncontrolled serious illness or medical condition
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
Major psychiatric illness | Major Depressive Disorder | Psychotic Disorder Major
Item
9. current major psychiatric disorder (e.g. major depression, psychosis)
boolean
C4534351 (UMLS CUI [1])
C1269683 (UMLS CUI [2])
C0033975 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
Study Subject Participation Status | Investigational New Drugs
Item
10. participation in another clinical study with an imp within one (1) month prior to inclusion
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Intolerance to Fluoropyrimidine | Suggestive of Dihydropyrimidine Dehydrogenase Deficiency
Item
11. known intolerance to fluoropyrimidine therapy suggestive of dihydropyrimidine dehydrogenase deficiency
boolean
C1744706 (UMLS CUI [1,1])
C0596581 (UMLS CUI [1,2])
C0332299 (UMLS CUI [2,1])
C1959620 (UMLS CUI [2,2])
Suspicion Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Investigational New Drugs Related | Hypersensitivity Folate Derivative
Item
12. suspicion of hypersensitivity or allergy to the imp, or to products chemically related to the imp (i.e. folate derivatives)
boolean
C0242114 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0439849 (UMLS CUI [2,4])
C0020517 (UMLS CUI [3,1])
C0178638 (UMLS CUI [3,2])
C1527240 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
13. female patients: currently pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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