ID

23845

Description

Phase II Trial of Combination Therapy With Irinotecan, S-1, and Bevacizumab (IRIS/Bev) in Patients With Unresectable or Recurrent Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00569790

Link

https://clinicaltrials.gov/show/NCT00569790

Keywords

Versions (2)
  1. 7/15/17 7/15/17 -
  2. 7/16/17 7/16/17 -
Uploaded on

July 15, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Colorectal Cancer NCT00569790

English

Eligibility Colorectal Cancer NCT00569790

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically confirmed colorectal carcinoma with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy
Description

Colorectal Carcinoma | Disease Inoperable | Disease Advanced Locally | Neoplasm Metastasis | Disease Inappropriate Curative treatment

Data type

boolean

Alias
UMLS CUI [1]
C0009402
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205187
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0205179
UMLS CUI [3,3]
C1517927
UMLS CUI [4]
C0027627
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C1548788
UMLS CUI [5,3]
C1273390
2. measurable disease or non-measurable but assessable disease according to the response evaluation criteria in solid tumors (recist)
Description

Measurable Disease | Disease Assessment Possible

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0332149
3. patients with no previous treatment (radiotherapy or chemotherapy). patients who have received postoperative adjuvant chemotherapy are eligible if relapse is diagnosed more than 180 days after the end of such treatment.
Description

Therapeutic radiology procedure Absent | Chemotherapy Absent | Adjuvant Chemotherapy Postoperative Discontinued | Recurrent disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0085533
UMLS CUI [3,2]
C0032790
UMLS CUI [3,3]
C1444662
UMLS CUI [4]
C0277556
4. age ≥20 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
5. life expectancy of at least 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
6. ecog ps of 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
7. adequate function of major organs as defined below:
Description

Organ Major function

Data type

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0031843
1. hemoglobin ≥9.0g/dl
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
2. white blood cell count ≥3,500/mm3
Description

White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1]
C0023508
3. neutrophil count ≥1,500/mm3
Description

Neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0200633
4. platelet count ≥100,000/mm3
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
5. total bilirubin ≤1.5 mg/dl
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
6. ast and alt ≤100 u/l (<200 u/l in patients with liver metastasis)
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
7. serum creatinine ≤1.2 mg/dl
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
8. creatinine clearance estimate by the cockcroft-gault method >50 ml/min (reduce initial dosage by one step if ≥50 but <80 ml/min)
Description

Estimation of creatinine clearance by Cockcroft-Gault formula | Dosage Initial Reduced

Data type

boolean

Alias
UMLS CUI [1]
C2711451
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0205265
UMLS CUI [2,3]
C0392756
8. able to take capsules orally.
Description

Able to swallow capsules

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0006935
9. no electrocardiographic abnormalities within 28 days before enrollment that would clinically preclude the execution of the study, as judged by the investigator.
Description

Electrocardiogram abnormal Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0332197
10. voluntary written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. serious drug hypersensitivity or a history of drug allergy
Description

Drug Allergy Serious | Drug Allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0013182
2. active double cancer
Description

Malignant Neoplasm Double

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205173
3. active infections (e.g., patients with pyrexia of 38℃ or higher)
Description

Communicable Diseases | Fever

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0015967
4. history of gastrointestinal perforation, intestinal tract paralysis, or ileus within 1 year.
Description

Gastrointestinal perforation | Intestines Paralysis | Ileus

Data type

boolean

Alias
UMLS CUI [1]
C0151664
UMLS CUI [2,1]
C0021853
UMLS CUI [2,2]
C0522224
UMLS CUI [3]
C1258215
5. uncontrolled hypertension
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
6. serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, or poorly controlled diabetes)
Description

Complication Serious | Pulmonary Fibrosis | Pneumonia, Interstitial | Heart failure | Kidney Failure | Liver Failure | poorly controlled diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0034069
UMLS CUI [3]
C0206061
UMLS CUI [4]
C0018801
UMLS CUI [5]
C0035078
UMLS CUI [6]
C0085605
UMLS CUI [7]
C0554876
7. moderate or severe ascites or pleural effusion requiring treatment
Description

Ascites Moderate | Ascites Severe | Pleural effusion Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0003962
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0032227
UMLS CUI [3,2]
C0332121
8. watery diarrhea
Description

Watery diarrhoea

Data type

boolean

Alias
UMLS CUI [1]
C0239182
9. treatment with flucytosine or atazanavir sulfate
Description

Flucytosine | Reyataz

Data type

boolean

Alias
UMLS CUI [1]
C0016278
UMLS CUI [2]
C1258207
10. metastasis to the cns
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
11. pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. men who are currently attempting to conceive children.
Description

Pregnancy | Possible pregnancy | Pregnancy, Planned | Breast Feeding | Gender Trying to conceive

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0425965
UMLS CUI [3]
C0032992
UMLS CUI [4]
C0006147
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0420843
12. severe mental disorder
Description

Mental disorders Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205082
13. continuous treatment with steroids
Description

Steroids

Data type

boolean

Alias
UMLS CUI [1]
C0038317
14. urine dipstick for proteinuria should be <2+
Description

Urine dipstick test Proteinuria

Data type

boolean

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0033687
15. patient with a past history of thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism
Description

Thrombosis | Cerebral Infarction | Myocardial Infarction | Pulmonary Embolism

Data type

boolean

Alias
UMLS CUI [1]
C0040053
UMLS CUI [2]
C0007785
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0034065
16. major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks
Description

Major surgery | Incisional biopsy | Traumatic injury

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0184922
UMLS CUI [3]
C3263723
17. long-term daily treatment with aspirin (>325 mg/day)
Description

Aspirin U/day Long-term

Data type

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0456683
UMLS CUI [1,3]
C0443252
18. history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
Description

Bleeding tendency Hereditary | Blood Coagulation Disorder Bleeding Risk

Data type

boolean

Alias
UMLS CUI [1,1]
C1458140
UMLS CUI [1,2]
C0439660
UMLS CUI [2,1]
C0005779
UMLS CUI [2,2]
C3251812
19. judged ineligible for participation in the study by the investigator for safety reasons.
Description

Study Subject Participation Status Ineligible | Patient safety At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1512714
UMLS CUI [2,1]
C1113679
UMLS CUI [2,2]
C1444641
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Similar models

Eligibility Colorectal Cancer NCT00569790

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma | Disease Inoperable | Disease Advanced Locally | Neoplasm Metastasis | Disease Inappropriate Curative treatment
Item
1. histologically confirmed colorectal carcinoma with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy
boolean
C0009402 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0205187 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C1517927 (UMLS CUI [3,3])
C0027627 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C1548788 (UMLS CUI [5,2])
C1273390 (UMLS CUI [5,3])
Measurable Disease | Disease Assessment Possible
Item
2. measurable disease or non-measurable but assessable disease according to the response evaluation criteria in solid tumors (recist)
boolean
C1513041 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0332149 (UMLS CUI [2,3])
Therapeutic radiology procedure Absent | Chemotherapy Absent | Adjuvant Chemotherapy Postoperative Discontinued | Recurrent disease
Item
3. patients with no previous treatment (radiotherapy or chemotherapy). patients who have received postoperative adjuvant chemotherapy are eligible if relapse is diagnosed more than 180 days after the end of such treatment.
boolean
C1522449 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0085533 (UMLS CUI [3,1])
C0032790 (UMLS CUI [3,2])
C1444662 (UMLS CUI [3,3])
C0277556 (UMLS CUI [4])
Age
Item
4. age ≥20 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
5. life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
6. ecog ps of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Organ Major function
Item
7. adequate function of major organs as defined below:
boolean
C0178784 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0031843 (UMLS CUI [1,3])
Hemoglobin measurement
Item
1. hemoglobin ≥9.0g/dl
boolean
C0518015 (UMLS CUI [1])
White Blood Cell Count procedure
Item
2. white blood cell count ≥3,500/mm3
boolean
C0023508 (UMLS CUI [1])
Neutrophil count
Item
3. neutrophil count ≥1,500/mm3
boolean
C0200633 (UMLS CUI [1])
Platelet Count measurement
Item
4. platelet count ≥100,000/mm3
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
5. total bilirubin ≤1.5 mg/dl
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver
Item
6. ast and alt ≤100 u/l (<200 u/l in patients with liver metastasis)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
Creatinine measurement, serum
Item
7. serum creatinine ≤1.2 mg/dl
boolean
C0201976 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula | Dosage Initial Reduced
Item
8. creatinine clearance estimate by the cockcroft-gault method >50 ml/min (reduce initial dosage by one step if ≥50 but <80 ml/min)
boolean
C2711451 (UMLS CUI [1])
C0178602 (UMLS CUI [2,1])
C0205265 (UMLS CUI [2,2])
C0392756 (UMLS CUI [2,3])
Able to swallow capsules
Item
8. able to take capsules orally.
boolean
C2712086 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
Electrocardiogram abnormal Absent
Item
9. no electrocardiographic abnormalities within 28 days before enrollment that would clinically preclude the execution of the study, as judged by the investigator.
boolean
C0522055 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Informed Consent
Item
10. voluntary written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Drug Allergy Serious | Drug Allergy
Item
1. serious drug hypersensitivity or a history of drug allergy
boolean
C0013182 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0013182 (UMLS CUI [2])
Malignant Neoplasm Double
Item
2. active double cancer
boolean
C0006826 (UMLS CUI [1,1])
C0205173 (UMLS CUI [1,2])
Communicable Diseases | Fever
Item
3. active infections (e.g., patients with pyrexia of 38℃ or higher)
boolean
C0009450 (UMLS CUI [1])
C0015967 (UMLS CUI [2])
Gastrointestinal perforation | Intestines Paralysis | Ileus
Item
4. history of gastrointestinal perforation, intestinal tract paralysis, or ileus within 1 year.
boolean
C0151664 (UMLS CUI [1])
C0021853 (UMLS CUI [2,1])
C0522224 (UMLS CUI [2,2])
C1258215 (UMLS CUI [3])
Uncontrolled hypertension
Item
5. uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Complication Serious | Pulmonary Fibrosis | Pneumonia, Interstitial | Heart failure | Kidney Failure | Liver Failure | poorly controlled diabetes mellitus
Item
6. serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, or poorly controlled diabetes)
boolean
C0009566 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0034069 (UMLS CUI [2])
C0206061 (UMLS CUI [3])
C0018801 (UMLS CUI [4])
C0035078 (UMLS CUI [5])
C0085605 (UMLS CUI [6])
C0554876 (UMLS CUI [7])
Ascites Moderate | Ascites Severe | Pleural effusion Treatment required for
Item
7. moderate or severe ascites or pleural effusion requiring treatment
boolean
C0003962 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0003962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0032227 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
Watery diarrhoea
Item
8. watery diarrhea
boolean
C0239182 (UMLS CUI [1])
Flucytosine | Reyataz
Item
9. treatment with flucytosine or atazanavir sulfate
boolean
C0016278 (UMLS CUI [1])
C1258207 (UMLS CUI [2])
CNS metastases
Item
10. metastasis to the cns
boolean
C0686377 (UMLS CUI [1])
Pregnancy | Possible pregnancy | Pregnancy, Planned | Breast Feeding | Gender Trying to conceive
Item
11. pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. men who are currently attempting to conceive children.
boolean
C0032961 (UMLS CUI [1])
C0425965 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
C0079399 (UMLS CUI [5,1])
C0420843 (UMLS CUI [5,2])
Mental disorders Severe
Item
12. severe mental disorder
boolean
C0004936 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Steroids
Item
13. continuous treatment with steroids
boolean
C0038317 (UMLS CUI [1])
Urine dipstick test Proteinuria
Item
14. urine dipstick for proteinuria should be <2+
boolean
C0430370 (UMLS CUI [1,1])
C0033687 (UMLS CUI [1,2])
Thrombosis | Cerebral Infarction | Myocardial Infarction | Pulmonary Embolism
Item
15. patient with a past history of thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism
boolean
C0040053 (UMLS CUI [1])
C0007785 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0034065 (UMLS CUI [4])
Major surgery | Incisional biopsy | Traumatic injury
Item
16. major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks
boolean
C0679637 (UMLS CUI [1])
C0184922 (UMLS CUI [2])
C3263723 (UMLS CUI [3])
Aspirin U/day Long-term
Item
17. long-term daily treatment with aspirin (>325 mg/day)
boolean
C0004057 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
Bleeding tendency Hereditary | Blood Coagulation Disorder Bleeding Risk
Item
18. history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
boolean
C1458140 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])
C0005779 (UMLS CUI [2,1])
C3251812 (UMLS CUI [2,2])
Study Subject Participation Status Ineligible | Patient safety At risk
Item
19. judged ineligible for participation in the study by the investigator for safety reasons.
boolean
C2348568 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
C1113679 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
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