ID

23886

Beschreibung

Phase II Trial of Combination Therapy With Bevacizumab and S-1 in Elderly Patients With Unresectable or Recurrent Colorectal Cancer (BASIC); ODM derived from: https://clinicaltrials.gov/show/NCT00569699

Link

https://clinicaltrials.gov/show/NCT00569699

Stichworte

Versionen (2)
  1. 15.07.17 15.07.17 -
  2. 16.07.17 16.07.17 -
Hochgeladen am

16. Juli 2017

DOI

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Eligibility Colorectal Cancer NCT00569699

Englisch

Eligibility Colorectal Cancer NCT00569699

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Colorectal Carcinoma | Disease Inoperable | Disease Advanced Locally | Neoplasm Metastasis | Curative treatment Access Lacking

Datentyp

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]
C1273390
UMLS CUI [5,2]
C0444454
UMLS CUI [5,3]
C0332268
2. measurable disease or non-measurable but assessable disease according to the response evaluation criteria in solid tumors (recist)
Beschreibung

Measurable Disease | Disease Assessment Possible

Datentyp

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.
Beschreibung

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

Datentyp

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. treatment with folfiri and folfox is not indicated.
Beschreibung

Folinic Acid-Fluorouracil-Irinotecan Regimen | FOLFOX Regimen

Datentyp

boolean

Alias
UMLS CUI [1]
C1880658
UMLS CUI [2]
C0392943
5. age >65 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
6. life expectancy of at least 3 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
7. ecog ps of 0, 1, or 2
Beschreibung

ECOG performance status

Datentyp

boolean

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

Organ Major function

Datentyp

boolean

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

Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
2. white blood cell count >3,500/mm3, <12,000/mm3
Beschreibung

White Blood Cell Count procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
3. neutrophil count >1,500/mm3
Beschreibung

Neutrophil count

Datentyp

boolean

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

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
5. total bilirubin <1.5 mg/dl
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
6. ast and alt <100 u/l (<200 u/l in patients with liver metastasis)
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0494165
7. serum creatinine <1.2 mg/dl
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
8. creatinine clearance estimate by the cockcroft-gault method >50 ml/min
Beschreibung

Estimation of creatinine clearance by Cockcroft-Gault formula

Datentyp

boolean

Alias
UMLS CUI [1]
C2711451
9. able to take capsules orally.
Beschreibung

Able to swallow capsules

Datentyp

boolean

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

Electrocardiogram abnormal Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C0332197
11. voluntary written informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Drug Allergy Serious | Drug Allergy

Datentyp

boolean

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

Malignant Neoplasm Double

Datentyp

boolean

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

Communicable Diseases | Fever

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0015967
4. uncontrolled hypertension
Beschreibung

Uncontrolled hypertension

Datentyp

boolean

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

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

Datentyp

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
6. moderate or severe ascites or pleural effusion requiring treatment
Beschreibung

Ascites Moderate | Ascites Severe | Pleural effusion Treatment required for

Datentyp

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
7. watery diarrhea
Beschreibung

Watery diarrhoea

Datentyp

boolean

Alias
UMLS CUI [1]
C0239182
8. treatment with flucytosine
Beschreibung

Flucytosine

Datentyp

boolean

Alias
UMLS CUI [1]
C0016278
9. metastasis to the cns
Beschreibung

CNS metastases

Datentyp

boolean

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

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

Datentyp

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
11. severe mental disorder
Beschreibung

Mental disorders Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205082
12. continuous treatment with steroids
Beschreibung

Steroids

Datentyp

boolean

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

Urine dipstick test Proteinuria

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0033687
14. thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism
Beschreibung

Thrombosis | Cerebral Infarction | Myocardial Infarction | Pulmonary Embolism

Datentyp

boolean

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

Major surgery | Incisional biopsy | Traumatic injury

Datentyp

boolean

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

Aspirin U/day Long-term

Datentyp

boolean

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

Bleeding tendency Hereditary | Blood Coagulation Disorder Bleeding Risk

Datentyp

boolean

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

Study Subject Participation Status Ineligible | Patient safety At risk

Datentyp

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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Ähnliche Modelle

Eligibility Colorectal Cancer NCT00569699

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma | Disease Inoperable | Disease Advanced Locally | Neoplasm Metastasis | Curative treatment Access Lacking
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])
C1273390 (UMLS CUI [5,1])
C0444454 (UMLS CUI [5,2])
C0332268 (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])
Folinic Acid-Fluorouracil-Irinotecan Regimen | FOLFOX Regimen
Item
4. treatment with folfiri and folfox is not indicated.
boolean
C1880658 (UMLS CUI [1])
C0392943 (UMLS CUI [2])
Age
Item
5. age >65 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
6. life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
7. ecog ps of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Organ Major function
Item
8. 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 >9.0 g/dl
boolean
C0518015 (UMLS CUI [1])
White Blood Cell Count procedure
Item
2. white blood cell count >3,500/mm3, <12,000/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
Item
8. creatinine clearance estimate by the cockcroft-gault method >50 ml/min
boolean
C2711451 (UMLS CUI [1])
Able to swallow capsules
Item
9. able to take capsules orally.
boolean
C2712086 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
Electrocardiogram abnormal Absent
Item
10. 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
11. 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])
Uncontrolled hypertension
Item
4. uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Complication Serious | Pulmonary Fibrosis | Pneumonia, Interstitial | Heart failure | Kidney Failure | Liver Failure | poorly controlled diabetes mellitus
Item
5. 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
6. 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
7. watery diarrhea
boolean
C0239182 (UMLS CUI [1])
Flucytosine
Item
8. treatment with flucytosine
boolean
C0016278 (UMLS CUI [1])
CNS metastases
Item
9. metastasis to the cns
boolean
C0686377 (UMLS CUI [1])
Pregnancy | Possible pregnancy | Pregnancy, Planned | Breast Feeding | Gender Trying to conceive
Item
10. 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
11. severe mental disorder
boolean
C0004936 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Steroids
Item
12. continuous treatment with steroids
boolean
C0038317 (UMLS CUI [1])
Urine dipstick test Proteinuria
Item
13. 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
14. 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
15. 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
16. 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
17. 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
18. 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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