ID

41167

Description

Cilengitide Together With Radiochemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01118676

Link

https://clinicaltrials.gov/show/NCT01118676

Keywords

Versions (1)
  1. 7/4/20 7/4/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 4, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Eligibility Locally Advanced Non Small Cell Lung Cancer (NSCLC)* NCT01118676

English

Eligibility Locally Advanced Non Small Cell Lung Cancer (NSCLC)* NCT01118676

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically proven non small cell lung cancer
Description

Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007131
2. inoperable tage iiia or iiib non small cell lung cancer
Description

Non-Small Cell Lung Carcinoma TNM clinical staging Inoperable

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [1,3]
C0205187
3. age ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. perflife expectancy ≥6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
5. hematological function : neutrophils ≥1500/mm3 and platelets ≥ 100000/mm3
Description

Hematologic function | Neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0032181
6. hepatic function: bilirubin within normal limits et ast and alt ≤ 2 times the upper limit of normal (uln).
Description

Liver function | Serum bilirubin normal | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0428443
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
7. renal function: creatinine ≤ 1.5 times uln.
Description

Renal function | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
8. absence of cardiac insufficiency, absence of unstable angina, absence of arrythmia
Description

Heart failure Absent | Unstable Angina Absent | Cardiac Arrhythmia Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0002965
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0332197
9. patient has health insurance coverage.
Description

Health Insurance coverage

Data type

boolean

Alias
UMLS CUI [1,1]
C0021682
UMLS CUI [1,2]
C1551362
10. signed informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients previously treated for a malignancy by means of chemotherapy, radiotherapy or surgery.
Description

Prior Therapy Malignant Neoplasm | Chemotherapy | Therapeutic radiology procedure | Operative Surgical Procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0006826
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0543467
2. uncontrolled hypertension
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
3. uncontrolled bleeding within the last 3 months.
Description

Bleeding uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C3842135
4. patients under anti-coagulation with anti-vitamin k or therapeutic dose heparin ; low-molecular heparins for prophylaxis are permitted and are not considered an exclusion criterion.
Description

Anticoagulation Therapy | Vitamin K Antagonist | Heparin Dose Therapeutic

Data type

boolean

Alias
UMLS CUI [1]
C0003281
UMLS CUI [2]
C2267235
UMLS CUI [3,1]
C0019134
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0302350
5. presence of cerebral metastases.
Description

Cerebral metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0555278
6. participation in a clinical trial within the last 8 weeks.
Description

Study Subject Participation Status | Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
7. any other specific concomitant anti-tumor treatment (such as chemotherapy, radiotherapy …).
Description

Cancer treatment Specific | Chemotherapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205369
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
8. patients with a history of myocardial infarction or a cerebral vascular accident within the last 12 months.
Description

Myocardial Infarction | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
9. continued use of aspirin (>325mg/day)
Description

Aspirin U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0456683
10. major surgery whiting the last 28 days or planned.
Description

Major surgery | Major surgery Planned

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C0679637
UMLS CUI [2,2]
C1301732
11. major non-healing wound, ulcer
Description

Non-healed Wound Major | Ulcer

Data type

boolean

Alias
UMLS CUI [1,1]
C0750433
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0041582
12. pregnant or breastfeeding women cannot participate in this trial. women of reproductive potential must have a negative pregnancy test (blood) within 72 hours before the start of treatment.
Description

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy blood test Negative

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0850355
UMLS CUI [3,3]
C1513916
13. men and women of reproductive potential must use an efficient contraceptive method when entering the trial and until one months after the end of treatment.
Description

Females & males of reproductive potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
14. history of a thrombo-embolic or hemorrhagic event.
Description

Thromboembolism | Event Hemorrhagic

Data type

boolean

Alias
UMLS CUI [1]
C0040038
UMLS CUI [2,1]
C0441471
UMLS CUI [2,2]
C0333275
15. patients put under tutelage.
Description

Patients Guardianship

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0870627
16. patients not able to follow the procedures visits, exams foreseen by the trial.
Description

Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
17. any other severe medical or psychiatric condition or biological anomaly - acute or chronic - that, in the investigator's opinion - may render the inclusion of the patient inappropriate.
Description

Other medical condition Severe Study Subject Participation Status Inappropriate | Mental condition Severe Study Subject Participation Status Inappropriate | Abnormality Study Subject Participation Status Inappropriate | Abnormality chronic Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C1548788
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C1548788
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C1548788
UMLS CUI [4,1]
C1704258
UMLS CUI [4,2]
C0205191
UMLS CUI [4,3]
C2348568
UMLS CUI [4,4]
C1548788
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Similar models

Eligibility Locally Advanced Non Small Cell Lung Cancer (NSCLC)* NCT01118676

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
1. histologically proven non small cell lung cancer
boolean
C0007131 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma TNM clinical staging Inoperable
Item
2. inoperable tage iiia or iiib non small cell lung cancer
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0205187 (UMLS CUI [1,3])
Age
Item
3. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
4. perflife expectancy ≥6 months
boolean
C0023671 (UMLS CUI [1])
Hematologic function | Neutrophil count | Platelet Count measurement
Item
5. hematological function : neutrophils ≥1500/mm3 and platelets ≥ 100000/mm3
boolean
C0221130 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Liver function | Serum bilirubin normal | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
6. hepatic function: bilirubin within normal limits et ast and alt ≤ 2 times the upper limit of normal (uln).
boolean
C0232741 (UMLS CUI [1])
C0428443 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Renal function | Creatinine measurement, serum
Item
7. renal function: creatinine ≤ 1.5 times uln.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Heart failure Absent | Unstable Angina Absent | Cardiac Arrhythmia Absent
Item
8. absence of cardiac insufficiency, absence of unstable angina, absence of arrythmia
boolean
C0018801 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0003811 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Health Insurance coverage
Item
9. patient has health insurance coverage.
boolean
C0021682 (UMLS CUI [1,1])
C1551362 (UMLS CUI [1,2])
Informed Consent
Item
10. signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Malignant Neoplasm | Chemotherapy | Therapeutic radiology procedure | Operative Surgical Procedure
Item
1. patients previously treated for a malignancy by means of chemotherapy, radiotherapy or surgery.
boolean
C1514463 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
Uncontrolled hypertension
Item
2. uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Bleeding uncontrolled
Item
3. uncontrolled bleeding within the last 3 months.
boolean
C3842135 (UMLS CUI [1])
Anticoagulation Therapy | Vitamin K Antagonist | Heparin Dose Therapeutic
Item
4. patients under anti-coagulation with anti-vitamin k or therapeutic dose heparin ; low-molecular heparins for prophylaxis are permitted and are not considered an exclusion criterion.
boolean
C0003281 (UMLS CUI [1])
C2267235 (UMLS CUI [2])
C0019134 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0302350 (UMLS CUI [3,3])
Cerebral metastasis
Item
5. presence of cerebral metastases.
boolean
C0555278 (UMLS CUI [1])
Study Subject Participation Status | Clinical Trial
Item
6. participation in a clinical trial within the last 8 weeks.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Cancer treatment Specific | Chemotherapy | Therapeutic radiology procedure
Item
7. any other specific concomitant anti-tumor treatment (such as chemotherapy, radiotherapy …).
boolean
C0920425 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
Myocardial Infarction | Cerebrovascular accident
Item
8. patients with a history of myocardial infarction or a cerebral vascular accident within the last 12 months.
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Aspirin U/day
Item
9. continued use of aspirin (>325mg/day)
boolean
C0004057 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Major surgery | Major surgery Planned
Item
10. major surgery whiting the last 28 days or planned.
boolean
C0679637 (UMLS CUI [1])
C0679637 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Non-healed Wound Major | Ulcer
Item
11. major non-healing wound, ulcer
boolean
C0750433 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0041582 (UMLS CUI [2])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy blood test Negative
Item
12. pregnant or breastfeeding women cannot participate in this trial. women of reproductive potential must have a negative pregnancy test (blood) within 72 hours before the start of treatment.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0850355 (UMLS CUI [3,2])
C1513916 (UMLS CUI [3,3])
Females & males of reproductive potential Contraceptive methods
Item
13. men and women of reproductive potential must use an efficient contraceptive method when entering the trial and until one months after the end of treatment.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Thromboembolism | Event Hemorrhagic
Item
14. history of a thrombo-embolic or hemorrhagic event.
boolean
C0040038 (UMLS CUI [1])
C0441471 (UMLS CUI [2,1])
C0333275 (UMLS CUI [2,2])
Patients Guardianship
Item
15. patients put under tutelage.
boolean
C0030705 (UMLS CUI [1,1])
C0870627 (UMLS CUI [1,2])
Protocol Compliance Unable
Item
16. patients not able to follow the procedures visits, exams foreseen by the trial.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Other medical condition Severe Study Subject Participation Status Inappropriate | Mental condition Severe Study Subject Participation Status Inappropriate | Abnormality Study Subject Participation Status Inappropriate | Abnormality chronic Study Subject Participation Status Inappropriate
Item
17. any other severe medical or psychiatric condition or biological anomaly - acute or chronic - that, in the investigator's opinion - may render the inclusion of the patient inappropriate.
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1548788 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1548788 (UMLS CUI [2,4])
C1704258 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1548788 (UMLS CUI [3,3])
C1704258 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C1548788 (UMLS CUI [4,4])
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