ID

42162

Beschrijving

Induction Study of Cisplatin, Docetaxel, and Nintedanib Stage IB-IIIA Non-Small Cell Lung Cancer (NCLC); ODM derived from: https://clinicaltrials.gov/show/NCT02225405

Link

https://clinicaltrials.gov/show/NCT02225405

Trefwoorden

  1. 23-09-15 23-09-15 - Julian Varghese
  2. 13-04-21 13-04-21 - Dr. rer. medic Philipp Neuhaus
  3. 18-11-21 18-11-21 -
Geüploaded op

13 april 2021

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Lung Cancer NCT02225405

Eligibility Lung Cancer NCT02225405

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693 (Inclusion)
1. age 18 years and older
Beschrijving

age 18 years and older

Datatype

boolean

Alias
UMLS CUI [1]
C0001779 (Age)
SNOMED
424144002
LOINC
LP28815-6
2. histologically or cytologically confirmed non-small cell lung cancer. patients with a suspected lung cancer are eligible, but pathology must be confirmed prior to initiating treatment on study. neuroendocrine carcinomas are not eligible. carcinomas with neuroendocrine differentiation are eligible.
Beschrijving

neuroendocrine carcinoma; differentiation; suspected; treatment; pathology; confirmed; cancer; small; study; lung; non

Datatype

boolean

Alias
UMLS CUI [1]
C0007131 (Non-Small Cell Lung Carcinoma)
SNOMED
254637007
UMLS CUI [2]
C0242379 (Malignant neoplasm of lung)
SNOMED
363358000
UMLS CUI [3,1]
C0206695 (Carcinoma, Neuroendocrine)
SNOMED
253000007
UMLS CUI [3,2]
C0007131 (Non-Small Cell Lung Carcinoma)
SNOMED
254637007
UMLS CUI [3,3]
C1709218 (Neuroendocrine Differentiation)
3. stage ib (with a primary tumor >/= 4cm), iia, iib, or iiia (according to ajcc 7th edition). patients with stage iiia must not have more than one mediastinal lymph node station involved by tumor.
Beschrijving

primary tumor; mediastinal; lymph node; stage iii; ajcc; one

Datatype

boolean

Alias
UMLS CUI [1]
C0280217 (stage, non-small cell lung cancer)
4. all patients must have lymph node evaluation of contralateral stations 2 and/or 4 to exclude n3 disease.
Beschrijving

all patients must; lymph node; disease

Datatype

boolean

Alias
UMLS CUI [1]
C0562297 (Examination of lymph nodes)
SNOMED
284427004
5. the patient must be a suitable candidate for surgery, in the opinion of the treating physician.
Beschrijving

treating physician; surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0205188 (Operable)
SNOMED
76234009
6. ecog performance status score 0-1
Beschrijving

ecog performance status; score

Datatype

boolean

Alias
UMLS CUI [1]
C1520224 (ECOG performance status)
SNOMED
423740007
7. signed and dated written informed consent prior to admission to the study in accordance with ich-gcp guidelines and to the local legislation
Beschrijving

signed and dated written informed consent is available; admission to; local; study

Datatype

boolean

Alias
UMLS CUI [1]
C0021430 (Informed Consent)
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251 (Exclusion Criteria)
1. prior systemic therapy or radiation therapy for treatment of the current lung cancer
Beschrijving

prior systemic therapy; radiation therapy; treatment; current; cancer; lung

Datatype

boolean

Alias
UMLS CUI [1]
C1515119 (Systemic Therapy)
UMLS CUI [2]
C1522449 (Therapeutic radiology procedure)
SNOMED
53438000
LOINC
LA4351-8
2. known hypersensitivity to the trial drugs or to their excipients
Beschrijving

hypersensitivity; drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517 (Hypersensitivity)
SNOMED
421961002
LOINC
LP20697-6
UMLS CUI [1,2]
C3854006 (clinical trial drug)
3. centrally located tumors with radiographic evidence (ct or mri) of local invasion of major blood vessels
Beschrijving

radiographic; vessels; blood; local; mri

Datatype

boolean

Alias
UMLS CUI [1]
C0677898 (Invasive Malignant Neoplasm)
4. radiographic evidence of cavitary or necrotic tumor
Beschrijving

radiographic; evidence of; tumor

Datatype

boolean

Alias
UMLS CUI [1]
C0746131 (lung lesion cavitary)
UMLS CUI [2]
C1300818 (Necrotic tumor)
SNOMED
396559007
5. major injuries within the past 10 days prior to start of study treatment with incomplete wound healing
Beschrijving

study treatment; incomplete; wound; start

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332677 (major injury)
UMLS CUI [1,2]
C0151692 (Impaired wound healing)
SNOMED
271618001
6. history of clinically significant haemorrhagic or thromboembolic event in the past 6 months
Beschrijving

clinically significant; thromboembolic event

Datatype

boolean

Alias
UMLS CUI [1]
C0005779 (Blood Coagulation Disorders)
SNOMED
64779008
7. known inherited predisposition to bleeding or thrombosis
Beschrijving

thrombosis; bleeding

Datatype

boolean

Alias
UMLS CUI [1,1]
C0439660 (Hereditary)
SNOMED
255404009
LOINC
LP30522-4
UMLS CUI [1,2]
C0005779 (Blood Coagulation Disorders)
SNOMED
64779008
8. significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within the past 12 months prior to start of study treatment, congestive heart failure > nyha ii, serious cardiac arrhythmia, pericardial effusion)
Beschrijving

uncontrolled hypertension; congestive heart failure; cardiovascular diseases; pericardial effusion; cardiac arrhythmia; unstable angina; study treatment; infarction; nyha ii; serious; start

Datatype

boolean

Alias
UMLS CUI [1]
C1868885 (Uncontrolled hypertension)
UMLS CUI [2]
C0018802 (Congestive heart failure)
SNOMED
42343007
LOINC
MTHU020787
UMLS CUI [3]
C0031039 (Pericardial effusion)
SNOMED
373945007
LOINC
LP411655-6
UMLS CUI [4]
C0003811 (Cardiac Arrhythmia)
SNOMED
698247007
LOINC
LA7414-1
UMLS CUI [5]
C0002965 (Angina, Unstable)
SNOMED
4557003
UMLS CUI [6]
C1275491 (New York Heart Association Classification)
SNOMED
420816009
LOINC
LP264302-3
UMLS CUI [7,1]
C0205082 (Severe (severity modifier))
SNOMED
24484000
LOINC
LA6750-9
UMLS CUI [7,2]
C0007222 (Cardiovascular Diseases)
SNOMED
49601007
9. creatinine > 1.5 institutional upper limit of normal. patients with creatinine > 1.5 the institutional upper limit of normal who have creatinine clearance >/= 60 cc/min (calculated using the cockcroft and gault equation) are eligible
Beschrijving

upper limit of normal (sgpt); upper limit of normal (sgot); creatinine clearance

Datatype

boolean

Alias
UMLS CUI [1]
C0373595 (Creatinine clearance measurement)
SNOMED
167181009
UMLS CUI [2]
C0201976 (Creatinine measurement, serum (procedure))
SNOMED
113075003
10. hepatic function: total bilirubin > institutional upper limit of normal or ast > 1.5 x institutional upper limit of normal
Beschrijving

total bilirubin - institutional upper limit of normal; upper limit of normal (sgpt); upper limit of normal (sgot); hepatic function; ast

Datatype

boolean

Alias
UMLS CUI [1]
C0201913 (Bilirubin, total measurement)
SNOMED
359986008
11. coagulation parameters: international normalised ratio (inr) > 2, prothrombin time (pt) and partial thromboplastin time (ptt) > 50% of deviation of institutional uln
Beschrijving

international normalised ratio (inr) > 2, prolongation of prothrombin time (pt) and partial thromboplastin time (ptt) by > 50% of institutional uln); coagulation

Datatype

boolean

Alias
UMLS CUI [1]
C2673577 (Prolonged prothrombin time (PT))
UMLS CUI [2]
C0525032 (International Normalized Ratio)
SNOMED
1951000175101
LOINC
LP20762-8
UMLS CUI [3]
C0030605 (Activated Partial Thromboplastin Time measurement)
SNOMED
42525009
12. absolute neutrophil count ( anc) < 1500/ml, and/or platelets < 100000/ml
Beschrijving

absolute neutrophil count; platelets; anc

Datatype

boolean

Alias
UMLS CUI [1]
C0948762 (Absolute neutrophil count)
UMLS CUI [2]
C0032181 (Platelet Count measurement)
SNOMED
61928009
13. prior malignancy requiring systemic therapy or radiation therapy within 1 year of randomization
Beschrijving

radiation therapy; systemic therapy; prior malignancy; randomization; year

Datatype

boolean

Alias
UMLS CUI [1]
C0006826 (Malignant Neoplasms)
SNOMED
363346000
LOINC
LP100805-3
UMLS CUI [2,1]
C1522449 (Therapeutic radiology procedure)
SNOMED
53438000
LOINC
LA4351-8
UMLS CUI [2,2]
C0686904 (Patient need for (contextual qualifier))
SNOMED
103325001
UMLS CUI [3,1]
C1515119 (Systemic Therapy)
UMLS CUI [3,2]
C0686904 (Patient need for (contextual qualifier))
SNOMED
103325001
14. active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy
Beschrijving

antibiotic; infections; systemic; therapy; serious; active

Datatype

boolean

Alias
UMLS CUI [1]
C0009450 (Communicable Diseases)
SNOMED
189822004
UMLS CUI [2,1]
C3540704 (Antibiotics for systemic use)
UMLS CUI [2,2]
C0686904 (Patient need for (contextual qualifier))
SNOMED
103325001
15. active or chronic hepatitis c and/or b infection
Beschrijving

chronic hepatitis c; infection; active

Datatype

boolean

Alias
UMLS CUI [1]
C0019163 (Hepatitis B)
SNOMED
66071002
LOINC
LA18126-5
UMLS CUI [2]
C0019196 (Hepatitis C)
SNOMED
50711007
LOINC
LA19423-5
16. gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
Beschrijving

gastrointestinal disorders; abnormalities; study; drug

Datatype

boolean

Alias
UMLS CUI [1]
C0596599 (gastrointestinal drug absorption)
17. serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study
Beschrijving

investigator; concomitant; laboratory; neurologic; disease; serious; entry; study; drug; non

Datatype

boolean

Alias
UMLS CUI [1]
C0814475 (patient risk management)
18. patients who are sexually active, with preserved reproductive capacity, and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial and for at least three months after end of active therapy
Beschrijving

contraceptives; contraception; combined; therapy; method; active; oral; end

Datatype

boolean

Alias
UMLS CUI [1]
C3831118 (Childbearing Potential)
UMLS CUI [2]
C0700589 (Contraceptive methods)
SNOMED
13197004
19. pregnancy or breast feeding.
Beschrijving

breast feeding; pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0006147 (Breast Feeding)
SNOMED
169741004
LOINC
LP420040-0
UMLS CUI [2]
C0549206 (Patient currently pregnant)
SNOMED
77386006
LOINC
LA14670-6
20. psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule.
Beschrijving

psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Datatype

boolean

Alias
UMLS CUI [1]
C0525058 (Protocol Compliance)
UMLS CUI [2]
C1658764 (psychological disease)
UMLS CUI [3]
C3850138 (Sociological Factors)

Similar models

Eligibility Lung Cancer NCT02225405

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
age 18 years and older
Item
1. age 18 years and older
boolean
C0001779 (UMLS CUI [1])
neuroendocrine carcinoma; differentiation; suspected; treatment; pathology; confirmed; cancer; small; study; lung; non
Item
2. histologically or cytologically confirmed non-small cell lung cancer. patients with a suspected lung cancer are eligible, but pathology must be confirmed prior to initiating treatment on study. neuroendocrine carcinomas are not eligible. carcinomas with neuroendocrine differentiation are eligible.
boolean
C0007131 (UMLS CUI [1])
C0242379 (UMLS CUI [2])
C0206695 (UMLS CUI [3,1])
C0007131 (UMLS CUI [3,2])
C1709218 (UMLS CUI [3,3])
primary tumor; mediastinal; lymph node; stage iii; ajcc; one
Item
3. stage ib (with a primary tumor >/= 4cm), iia, iib, or iiia (according to ajcc 7th edition). patients with stage iiia must not have more than one mediastinal lymph node station involved by tumor.
boolean
C0280217 (UMLS CUI [1])
all patients must; lymph node; disease
Item
4. all patients must have lymph node evaluation of contralateral stations 2 and/or 4 to exclude n3 disease.
boolean
C0562297 (UMLS CUI [1])
treating physician; surgery
Item
5. the patient must be a suitable candidate for surgery, in the opinion of the treating physician.
boolean
C0205188 (UMLS CUI [1])
ecog performance status; score
Item
6. ecog performance status score 0-1
boolean
C1520224 (UMLS CUI [1])
signed and dated written informed consent is available; admission to; local; study
Item
7. signed and dated written informed consent prior to admission to the study in accordance with ich-gcp guidelines and to the local legislation
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
prior systemic therapy; radiation therapy; treatment; current; cancer; lung
Item
1. prior systemic therapy or radiation therapy for treatment of the current lung cancer
boolean
C1515119 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
hypersensitivity; drugs
Item
2. known hypersensitivity to the trial drugs or to their excipients
boolean
C0020517 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
radiographic; vessels; blood; local; mri
Item
3. centrally located tumors with radiographic evidence (ct or mri) of local invasion of major blood vessels
boolean
C0677898 (UMLS CUI [1])
radiographic; evidence of; tumor
Item
4. radiographic evidence of cavitary or necrotic tumor
boolean
C0746131 (UMLS CUI [1])
C1300818 (UMLS CUI [2])
study treatment; incomplete; wound; start
Item
5. major injuries within the past 10 days prior to start of study treatment with incomplete wound healing
boolean
C0332677 (UMLS CUI [1,1])
C0151692 (UMLS CUI [1,2])
clinically significant; thromboembolic event
Item
6. history of clinically significant haemorrhagic or thromboembolic event in the past 6 months
boolean
C0005779 (UMLS CUI [1])
thrombosis; bleeding
Item
7. known inherited predisposition to bleeding or thrombosis
boolean
C0439660 (UMLS CUI [1,1])
C0005779 (UMLS CUI [1,2])
uncontrolled hypertension; congestive heart failure; cardiovascular diseases; pericardial effusion; cardiac arrhythmia; unstable angina; study treatment; infarction; nyha ii; serious; start
Item
8. significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within the past 12 months prior to start of study treatment, congestive heart failure > nyha ii, serious cardiac arrhythmia, pericardial effusion)
boolean
C1868885 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C0031039 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C1275491 (UMLS CUI [6])
C0205082 (UMLS CUI [7,1])
C0007222 (UMLS CUI [7,2])
upper limit of normal (sgpt); upper limit of normal (sgot); creatinine clearance
Item
9. creatinine > 1.5 institutional upper limit of normal. patients with creatinine > 1.5 the institutional upper limit of normal who have creatinine clearance >/= 60 cc/min (calculated using the cockcroft and gault equation) are eligible
boolean
C0373595 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
total bilirubin - institutional upper limit of normal; upper limit of normal (sgpt); upper limit of normal (sgot); hepatic function; ast
Item
10. hepatic function: total bilirubin > institutional upper limit of normal or ast > 1.5 x institutional upper limit of normal
boolean
C0201913 (UMLS CUI [1])
international normalised ratio (inr) > 2, prolongation of prothrombin time (pt) and partial thromboplastin time (ptt) by > 50% of institutional uln); coagulation
Item
11. coagulation parameters: international normalised ratio (inr) > 2, prothrombin time (pt) and partial thromboplastin time (ptt) > 50% of deviation of institutional uln
boolean
C2673577 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
C0030605 (UMLS CUI [3])
absolute neutrophil count; platelets; anc
Item
12. absolute neutrophil count ( anc) < 1500/ml, and/or platelets < 100000/ml
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
radiation therapy; systemic therapy; prior malignancy; randomization; year
Item
13. prior malignancy requiring systemic therapy or radiation therapy within 1 year of randomization
boolean
C0006826 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C1515119 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
antibiotic; infections; systemic; therapy; serious; active
Item
14. active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy
boolean
C0009450 (UMLS CUI [1])
C3540704 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
chronic hepatitis c; infection; active
Item
15. active or chronic hepatitis c and/or b infection
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
gastrointestinal disorders; abnormalities; study; drug
Item
16. gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
boolean
C0596599 (UMLS CUI [1])
investigator; concomitant; laboratory; neurologic; disease; serious; entry; study; drug; non
Item
17. serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study
boolean
C0814475 (UMLS CUI [1])
contraceptives; contraception; combined; therapy; method; active; oral; end
Item
18. patients who are sexually active, with preserved reproductive capacity, and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial and for at least three months after end of active therapy
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
breast feeding; pregnancy
Item
19. pregnancy or breast feeding.
boolean
C0006147 (UMLS CUI [1])
C0549206 (UMLS CUI [2])
psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Item
20. psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule.
boolean
C0525058 (UMLS CUI [1])
C1658764 (UMLS CUI [2])
C3850138 (UMLS CUI [3])

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