ID

44779

Description

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

Keywords

Versions (3)
  1. 9/23/15 9/23/15 - Julian Varghese
  2. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  3. 11/18/21 11/18/21 -
Copyright Holder

M.D. Anderson Cancer Center; NCI

Uploaded on

November 18, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT02225405

English

Eligibility Lung Cancer NCT02225405

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18 years and older
Description

age 18 years and older

Data type

boolean

Alias
UMLS CUI [1]
C0001779
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C0242379
UMLS CUI [3]
C0206695
UMLS CUI [4,1]
C0007131
UMLS CUI [4,2]
C1709218
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0280217
4. all patients must have lymph node evaluation of contralateral stations 2 and/or 4 to exclude n3 disease.
Description

all patients must; lymph node; disease

Data type

boolean

Alias
UMLS CUI [1]
C0562297
5. the patient must be a suitable candidate for surgery, in the opinion of the treating physician.
Description

treating physician; surgery

Data type

boolean

Alias
UMLS CUI [1]
C0205188
6. ecog performance status score 0-1
Description

ecog performance status; score

Data type

boolean

Alias
UMLS CUI [1]
C1520224
7. signed and dated written informed consent prior to admission to the study in accordance with ich-gcp guidelines and to the local legislation
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior systemic therapy or radiation therapy for treatment of the current lung cancer
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C1515119
UMLS CUI [2]
C1522449
2. known hypersensitivity to the trial drugs or to their excipients
Description

hypersensitivity; drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3854006
3. centrally located tumors with radiographic evidence (ct or mri) of local invasion of major blood vessels
Description

radiographic; vessels; blood; local; mri

Data type

boolean

Alias
UMLS CUI [1]
C0677898
4. radiographic evidence of cavitary or necrotic tumor
Description

radiographic; evidence of; tumor

Data type

boolean

Alias
UMLS CUI [1]
C0746131
UMLS CUI [2]
C1300818
5. major injuries within the past 10 days prior to start of study treatment with incomplete wound healing
Description

study treatment; incomplete; wound; start

Data type

boolean

Alias
UMLS CUI [1,1]
C0332677
UMLS CUI [1,2]
C0151692
6. history of clinically significant haemorrhagic or thromboembolic event in the past 6 months
Description

clinically significant; thromboembolic event

Data type

boolean

Alias
UMLS CUI [1]
C0005779
7. known inherited predisposition to bleeding or thrombosis
Description

thrombosis; bleeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0439660
UMLS CUI [1,2]
C0005779
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)
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0031039
UMLS CUI [4]
C0003811
UMLS CUI [5]
C0002965
UMLS CUI [6]
C1275491
UMLS CUI [7,1]
C0205082
UMLS CUI [7,2]
C0007222
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
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2]
C0201976
10. hepatic function: total bilirubin > institutional upper limit of normal or ast > 1.5 x institutional upper limit of normal
Description

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

Data type

boolean

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

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

Data type

boolean

Alias
UMLS CUI [1]
C2673577
UMLS CUI [2]
C0525032
UMLS CUI [3]
C0030605
12. absolute neutrophil count ( anc) < 1500/ml, and/or platelets < 100000/ml
Description

absolute neutrophil count; platelets; anc

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
13. prior malignancy requiring systemic therapy or radiation therapy within 1 year of randomization
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0686904
UMLS CUI [3,1]
C1515119
UMLS CUI [3,2]
C0686904
14. active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy
Description

antibiotic; infections; systemic; therapy; serious; active

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C3540704
UMLS CUI [2,2]
C0686904
15. active or chronic hepatitis c and/or b infection
Description

chronic hepatitis c; infection; active

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
16. gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
Description

gastrointestinal disorders; abnormalities; study; drug

Data type

boolean

Alias
UMLS CUI [1]
C0596599
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
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0814475
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
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
19. pregnancy or breast feeding.
Description

breast feeding; pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0549206
20. psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C1658764
UMLS CUI [3]
C3850138
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Similar models

Eligibility Lung Cancer NCT02225405

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
C0007131 (UMLS CUI [4,1])
C1709218 (UMLS CUI [4,2])
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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