ID

44779

Beschreibung

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

Stichworte

Versionen (3)
  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 -
Rechteinhaber

M.D. Anderson Cancer Center; NCI

Hochgeladen am

18. November 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT02225405

Englisch

Eligibility Lung Cancer NCT02225405

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

age 18 years and older

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

all patients must; lymph node; disease

Datentyp

boolean

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

treating physician; surgery

Datentyp

boolean

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

ecog performance status; score

Datentyp

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
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

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

Datentyp

boolean

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

hypersensitivity; drugs

Datentyp

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
Beschreibung

radiographic; vessels; blood; local; mri

Datentyp

boolean

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

radiographic; evidence of; tumor

Datentyp

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
Beschreibung

study treatment; incomplete; wound; start

Datentyp

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
Beschreibung

clinically significant; thromboembolic event

Datentyp

boolean

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

thrombosis; bleeding

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

absolute neutrophil count; platelets; anc

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

antibiotic; infections; systemic; therapy; serious; active

Datentyp

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
Beschreibung

chronic hepatitis c; infection; active

Datentyp

boolean

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

gastrointestinal disorders; abnormalities; study; drug

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

boolean

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

breast feeding; pregnancy

Datentyp

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.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C1658764
UMLS CUI [3]
C3850138
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Ähnliche Modelle

Eligibility Lung Cancer NCT02225405

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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