ID

44779

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02225405

Nyckelord

  1. 2015-09-23 2015-09-23 - Julian Varghese
  2. 2021-04-13 2021-04-13 - Dr. rer. medic Philipp Neuhaus
  3. 2021-11-18 2021-11-18 -
Rättsinnehavare

M.D. Anderson Cancer Center; NCI

Uppladdad den

18 november 2021

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :


    Inga kommentarer

    Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

    Eligibility Lung Cancer NCT02225405

    Eligibility Lung Cancer NCT02225405

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

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

    age 18 years and older

    Datatyp

    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.
    Beskrivning

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

    Datatyp

    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.
    Beskrivning

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

    Datatyp

    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.
    Beskrivning

    all patients must; lymph node; disease

    Datatyp

    boolean

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

    treating physician; surgery

    Datatyp

    boolean

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

    ecog performance status; score

    Datatyp

    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
    Beskrivning

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

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

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

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

    Datatyp

    boolean

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

    hypersensitivity; drugs

    Datatyp

    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
    Beskrivning

    radiographic; vessels; blood; local; mri

    Datatyp

    boolean

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

    radiographic; evidence of; tumor

    Datatyp

    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
    Beskrivning

    study treatment; incomplete; wound; start

    Datatyp

    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
    Beskrivning

    clinically significant; thromboembolic event

    Datatyp

    boolean

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

    thrombosis; bleeding

    Datatyp

    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)
    Beskrivning

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

    Datatyp

    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
    Beskrivning

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

    Datatyp

    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
    Beskrivning

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

    Datatyp

    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
    Beskrivning

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

    Datatyp

    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
    Beskrivning

    absolute neutrophil count; platelets; anc

    Datatyp

    boolean

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

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

    Datatyp

    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
    Beskrivning

    antibiotic; infections; systemic; therapy; serious; active

    Datatyp

    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
    Beskrivning

    chronic hepatitis c; infection; active

    Datatyp

    boolean

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

    gastrointestinal disorders; abnormalities; study; drug

    Datatyp

    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
    Beskrivning

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

    Datatyp

    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
    Beskrivning

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

    Datatyp

    boolean

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

    breast feeding; pregnancy

    Datatyp

    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.
    Beskrivning

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

    Datatyp

    boolean

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

    Similar models

    Eligibility Lung Cancer NCT02225405

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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])

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial