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ID

42312

Beskrivning

Study of Everolimus in Patients With Thymoma and Thymic Carcinoma Previously Treated With Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT02049047

Länk

https://clinicaltrials.gov/show/NCT02049047

Nyckelord

Versioner (2)
  1. 2021-05-28 2021-05-28 -
  2. 2021-06-11 2021-06-11 -
Rättsinnehavare

Armando Santoro, MD, Istituto Clinico Humanitas

Uppladdad den

28 maj 2021

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Thymoma and Thymic Carcinoma NCT02049047

    Engelsk

    Eligibility Thymoma and Thymic Carcinoma NCT02049047

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    histological diagnosis of invasive recurrent or metastatic thymoma or thymic carcinoma confirmed by pathologist
    Beskrivning

    Histologically diagnosed invasive recurrent thymoma or thymic carcinoma | histologically diagnosed metastatic thymoma or thymic carcinoma

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0679557
    UMLS CUI [1,2]
    C0040100
    UMLS CUI [1,3]
    C0205281
    UMLS CUI [1,4]
    C2945760
    UMLS CUI [2,1]
    C0679557
    UMLS CUI [2,2]
    C0205969
    UMLS CUI [2,3]
    C0205281
    UMLS CUI [2,4]
    C2945760
    UMLS CUI [3,1]
    C0679557
    UMLS CUI [3,2]
    C0040100
    UMLS CUI [3,3]
    C0027627
    UMLS CUI [4,1]
    C0679557
    UMLS CUI [4,2]
    C0205969
    UMLS CUI [4,3]
    C0027627
    at least one prior platinum-containing chemotherapy regimen. there is no limit to the number of prior chemotherapy regimens received. progressive disease should have been documented before entry into the study
    Beskrivning

    Prior platinum-based chemotherapy | documented progressive disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457
    UMLS CUI [1,2]
    C1514162
    UMLS CUI [2]
    C0242656
    measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than 20 mm with conventional techniques or as greater than 10 mm with spiral ct scan
    Beskrivning

    Measurable thymoma through diagnostic imaging | measurable thymic carcinoma through diagnostic imaging

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0040100
    UMLS CUI [1,2]
    C1513041
    UMLS CUI [1,3]
    C0011923
    UMLS CUI [2,1]
    C0205969
    UMLS CUI [2,2]
    C1513041
    UMLS CUI [2,3]
    C0011923
    patients must have recovered from toxicity related to prior therapy at least to grade 1 (defined by ctcae 3.0)
    Beskrivning

    Recovery from toxicity due to prior therapy | NCI adverse events criteria

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0600688
    UMLS CUI [1,2]
    C1514463
    UMLS CUI [1,3]
    C1115804
    UMLS CUI [2]
    C1516728
    no major surgery, radiation therapy, chemotherapy, biologic therapy (including any investigational agents), or hormonal therapy (other than replacement), within 4 weeks prior to entering the study
    Beskrivning

    No recent major surgery | no recent radiation therapy | no recent chemotherapy | no recent biologic therapy | no recent hormonal therapy except replacement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0679637
    UMLS CUI [1,2]
    C0332185
    UMLS CUI [1,3]
    C0332197
    UMLS CUI [2,1]
    C1522449
    UMLS CUI [2,2]
    C0332185
    UMLS CUI [2,3]
    C0332197
    UMLS CUI [3,1]
    C0392920
    UMLS CUI [3,2]
    C0332185
    UMLS CUI [3,3]
    C0332197
    UMLS CUI [4,1]
    C1531518
    UMLS CUI [4,2]
    C0332185
    UMLS CUI [4,3]
    C0332197
    UMLS CUI [5,1]
    C0013230
    UMLS CUI [5,2]
    C0332185
    UMLS CUI [5,3]
    C0332197
    UMLS CUI [6,1]
    C0279025
    UMLS CUI [6,2]
    C0332185
    UMLS CUI [6,3]
    C0332197
    UMLS CUI [7,1]
    C0332300
    UMLS CUI [7,2]
    C0282402
    life expectancy of at least 3 months
    Beskrivning

    Life Expectancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    performance status (ecog)<=2
    Beskrivning

    ECOG performance status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    negative pregnancy test (if female in reproductive years)
    Beskrivning

    Negative pregnancy test

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0427780
    adequate organ and marrow function (as defined below)
    Beskrivning

    Organ function adequate | marrow function adequate

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0678852
    UMLS CUI [1,2]
    C0031843
    UMLS CUI [2,1]
    C0005953
    UMLS CUI [2,2]
    C0031843
    leukocytes >=3,000/mm^3, absolute neutrophil count >=1,500/mm^3, hemoglobin>= 9 g/dl, platelets>= 100,000/mm^3, total bilirubin >= 1.5 x institutional upper limit of normal (uln), ast(sgot)/alt(sgpt)>= 3 x institutional uln (5x if lft elevations due to liver metastases, )creatinine <= 1.5 x institutional uln
    Beskrivning

    Haematology and clinical chemistry thresholds

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023508
    UMLS CUI [2]
    C0948762
    UMLS CUI [3]
    C0518015
    UMLS CUI [4]
    C0005821
    UMLS CUI [5]
    C1278039
    UMLS CUI [6]
    C0201899
    UMLS CUI [7]
    C0201836
    UMLS CUI [8]
    C0201976
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients with symptomatic brain metastases. however, patients who have had treatment for their brain metastases and whose brain metastatic disease status has remained stable for at least 3 months without steroids may be enrolled at the discretion of the investigator.
    Beskrivning

    Patients with brain metastases | excl. adequately treated | excl. stable status without steroids

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0220650
    UMLS CUI [1,2]
    C0231220
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0220650
    UMLS CUI [2,3]
    C0087111
    UMLS CUI [2,4]
    C0205411
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0220650
    UMLS CUI [3,3]
    C0205360
    UMLS CUI [3,4]
    C0038317
    UMLS CUI [3,5]
    C0332197
    major surgery, other than diagnostic surgery, within 4 weeks prior to treatment
    Beskrivning

    Recent major surgery | excl. diagnostic surgery

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0679637
    UMLS CUI [1,2]
    C0332185
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0522769
    active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
    Beskrivning

    Uncontrolled bacterial infection requiring systemic therapy | uncontrolled viral infection requiring systemic therapy | uncontrolled fungal infection requiring systemic therapy

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0004623
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [1,3]
    C1514873
    UMLS CUI [1,4]
    C1515119
    UMLS CUI [2,1]
    C0042769
    UMLS CUI [2,2]
    C0205318
    UMLS CUI [2,3]
    C1514873
    UMLS CUI [2,4]
    C1515119
    UMLS CUI [3,1]
    C0026946
    UMLS CUI [3,2]
    C0205318
    UMLS CUI [3,3]
    C1514873
    UMLS CUI [3,4]
    C1515119
    pregnant or breast feeding women
    Beskrivning

    Pregnancy or breast feeding

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    previous (within the last 5 years) or current malignancies at other sites, except for adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri
    Beskrivning

    Other previous malignancies | other current malignancies | except adequately treated basal cell carcinoma | except adequately treated squamous cell carcinoma | except adequately treated cervix uteri carcinoma

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0205156
    UMLS CUI [2,1]
    C0006826
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [2,3]
    C0521116
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0007117
    UMLS CUI [3,3]
    C0920425
    UMLS CUI [3,4]
    C0205411
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0553723
    UMLS CUI [4,3]
    C0920425
    UMLS CUI [4,4]
    C0205411
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C0851140
    UMLS CUI [5,3]
    C0920425
    UMLS CUI [5,4]
    C0205411
    current enrollment in or participation in another therapeutic clinical trial within 4 weeks preceding treatment start.
    Beskrivning

    Participation in another clinical trial

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0332185
    other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the patient inappropriate for entry into this study or could compromise protocol objectives in the opinion of the investigator and/or the sponsor.
    Beskrivning

    C0001314 C0205082 C0205394 C0521102 C2348563 | C0001314 C0205082 C0205394 C0035647 C1113679 | C0008679 C0205082 C0205394 C0521102 C2348563 | C0008679 C0205082 C0205394 C0035647 C1113679 | C0004936 C0521102 C2348563 | C0004936 C0035647 C1113679 | C0438215 C0521102 C2348563 | C0438215 C0035647 C1113679

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0001314
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C0521102
    UMLS CUI [1,5]
    C2348563
    UMLS CUI [2,1]
    C0001314
    UMLS CUI [2,2]
    C0205082
    UMLS CUI [2,3]
    C0205394
    UMLS CUI [2,4]
    C0035647
    UMLS CUI [2,5]
    C1113679
    UMLS CUI [3,1]
    C0008679
    UMLS CUI [3,2]
    C0205082
    UMLS CUI [3,3]
    C0205394
    UMLS CUI [3,4]
    C0521102
    UMLS CUI [3,5]
    C2348563
    UMLS CUI [4,1]
    C0008679
    UMLS CUI [4,2]
    C0205082
    UMLS CUI [4,3]
    C0205394
    UMLS CUI [4,4]
    C0035647
    UMLS CUI [4,5]
    C1113679
    UMLS CUI [5,1]
    C0004936
    UMLS CUI [5,2]
    C0521102
    UMLS CUI [5,3]
    C2348563
    UMLS CUI [6,1]
    C0004936
    UMLS CUI [6,2]
    C0035647
    UMLS CUI [6,3]
    C1113679
    UMLS CUI [7,1]
    C0438215
    UMLS CUI [7,2]
    C0521102
    UMLS CUI [7,3]
    C2348563
    UMLS CUI [8,1]
    C0438215
    UMLS CUI [8,2]
    C0035647
    UMLS CUI [8,3]
    C1113679
    Tillbaka till toppen

    Similar models

    Eligibility Thymoma and Thymic Carcinoma NCT02049047

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Histologically diagnosed invasive recurrent thymoma or thymic carcinoma | histologically diagnosed metastatic thymoma or thymic carcinoma
    Item
    histological diagnosis of invasive recurrent or metastatic thymoma or thymic carcinoma confirmed by pathologist
    boolean
    C0679557 (UMLS CUI [1,1])
    C0040100 (UMLS CUI [1,2])
    C0205281 (UMLS CUI [1,3])
    C2945760 (UMLS CUI [1,4])
    C0679557 (UMLS CUI [2,1])
    C0205969 (UMLS CUI [2,2])
    C0205281 (UMLS CUI [2,3])
    C2945760 (UMLS CUI [2,4])
    C0679557 (UMLS CUI [3,1])
    C0040100 (UMLS CUI [3,2])
    C0027627 (UMLS CUI [3,3])
    C0679557 (UMLS CUI [4,1])
    C0205969 (UMLS CUI [4,2])
    C0027627 (UMLS CUI [4,3])
    Prior platinum-based chemotherapy | documented progressive disease
    Item
    at least one prior platinum-containing chemotherapy regimen. there is no limit to the number of prior chemotherapy regimens received. progressive disease should have been documented before entry into the study
    boolean
    C1514457 (UMLS CUI [1,1])
    C1514162 (UMLS CUI [1,2])
    C0242656 (UMLS CUI [2])
    Measurable thymoma through diagnostic imaging | measurable thymic carcinoma through diagnostic imaging
    Item
    measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than 20 mm with conventional techniques or as greater than 10 mm with spiral ct scan
    boolean
    C0040100 (UMLS CUI [1,1])
    C1513041 (UMLS CUI [1,2])
    C0011923 (UMLS CUI [1,3])
    C0205969 (UMLS CUI [2,1])
    C1513041 (UMLS CUI [2,2])
    C0011923 (UMLS CUI [2,3])
    Recovery from toxicity due to prior therapy | NCI adverse events criteria
    Item
    patients must have recovered from toxicity related to prior therapy at least to grade 1 (defined by ctcae 3.0)
    boolean
    C0600688 (UMLS CUI [1,1])
    C1514463 (UMLS CUI [1,2])
    C1115804 (UMLS CUI [1,3])
    C1516728 (UMLS CUI [2])
    No recent major surgery | no recent radiation therapy | no recent chemotherapy | no recent biologic therapy | no recent hormonal therapy except replacement
    Item
    no major surgery, radiation therapy, chemotherapy, biologic therapy (including any investigational agents), or hormonal therapy (other than replacement), within 4 weeks prior to entering the study
    boolean
    C0679637 (UMLS CUI [1,1])
    C0332185 (UMLS CUI [1,2])
    C0332197 (UMLS CUI [1,3])
    C1522449 (UMLS CUI [2,1])
    C0332185 (UMLS CUI [2,2])
    C0332197 (UMLS CUI [2,3])
    C0392920 (UMLS CUI [3,1])
    C0332185 (UMLS CUI [3,2])
    C0332197 (UMLS CUI [3,3])
    C1531518 (UMLS CUI [4,1])
    C0332185 (UMLS CUI [4,2])
    C0332197 (UMLS CUI [4,3])
    C0013230 (UMLS CUI [5,1])
    C0332185 (UMLS CUI [5,2])
    C0332197 (UMLS CUI [5,3])
    C0279025 (UMLS CUI [6,1])
    C0332185 (UMLS CUI [6,2])
    C0332197 (UMLS CUI [6,3])
    C0332300 (UMLS CUI [7,1])
    C0282402 (UMLS CUI [7,2])
    Life Expectancy
    Item
    life expectancy of at least 3 months
    boolean
    C0023671 (UMLS CUI [1])
    ECOG performance status
    Item
    performance status (ecog)<=2
    boolean
    C1520224 (UMLS CUI [1])
    Negative pregnancy test
    Item
    negative pregnancy test (if female in reproductive years)
    boolean
    C0427780 (UMLS CUI [1])
    Organ function adequate | marrow function adequate
    Item
    adequate organ and marrow function (as defined below)
    boolean
    C0678852 (UMLS CUI [1,1])
    C0031843 (UMLS CUI [1,2])
    C0005953 (UMLS CUI [2,1])
    C0031843 (UMLS CUI [2,2])
    Haematology and clinical chemistry thresholds
    Item
    leukocytes >=3,000/mm^3, absolute neutrophil count >=1,500/mm^3, hemoglobin>= 9 g/dl, platelets>= 100,000/mm^3, total bilirubin >= 1.5 x institutional upper limit of normal (uln), ast(sgot)/alt(sgpt)>= 3 x institutional uln (5x if lft elevations due to liver metastases, )creatinine <= 1.5 x institutional uln
    boolean
    C0023508 (UMLS CUI [1])
    C0948762 (UMLS CUI [2])
    C0518015 (UMLS CUI [3])
    C0005821 (UMLS CUI [4])
    C1278039 (UMLS CUI [5])
    C0201899 (UMLS CUI [6])
    C0201836 (UMLS CUI [7])
    C0201976 (UMLS CUI [8])
    Item Group
    C0680251 (UMLS CUI)
    Patients with brain metastases | excl. adequately treated | excl. stable status without steroids
    Item
    patients with symptomatic brain metastases. however, patients who have had treatment for their brain metastases and whose brain metastatic disease status has remained stable for at least 3 months without steroids may be enrolled at the discretion of the investigator.
    boolean
    C0220650 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
    C1705847 (UMLS CUI [2,1])
    C0220650 (UMLS CUI [2,2])
    C0087111 (UMLS CUI [2,3])
    C0205411 (UMLS CUI [2,4])
    C1705847 (UMLS CUI [3,1])
    C0220650 (UMLS CUI [3,2])
    C0205360 (UMLS CUI [3,3])
    C0038317 (UMLS CUI [3,4])
    C0332197 (UMLS CUI [3,5])
    Recent major surgery | excl. diagnostic surgery
    Item
    major surgery, other than diagnostic surgery, within 4 weeks prior to treatment
    boolean
    C0679637 (UMLS CUI [1,1])
    C0332185 (UMLS CUI [1,2])
    C1705847 (UMLS CUI [2,1])
    C0522769 (UMLS CUI [2,2])
    Uncontrolled bacterial infection requiring systemic therapy | uncontrolled viral infection requiring systemic therapy | uncontrolled fungal infection requiring systemic therapy
    Item
    active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
    boolean
    C0004623 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C1514873 (UMLS CUI [1,3])
    C1515119 (UMLS CUI [1,4])
    C0042769 (UMLS CUI [2,1])
    C0205318 (UMLS CUI [2,2])
    C1514873 (UMLS CUI [2,3])
    C1515119 (UMLS CUI [2,4])
    C0026946 (UMLS CUI [3,1])
    C0205318 (UMLS CUI [3,2])
    C1514873 (UMLS CUI [3,3])
    C1515119 (UMLS CUI [3,4])
    Pregnancy or breast feeding
    Item
    pregnant or breast feeding women
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Other previous malignancies | other current malignancies | except adequately treated basal cell carcinoma | except adequately treated squamous cell carcinoma | except adequately treated cervix uteri carcinoma
    Item
    previous (within the last 5 years) or current malignancies at other sites, except for adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri
    boolean
    C0006826 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0205156 (UMLS CUI [1,3])
    C0006826 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0521116 (UMLS CUI [2,3])
    C1705847 (UMLS CUI [3,1])
    C0007117 (UMLS CUI [3,2])
    C0920425 (UMLS CUI [3,3])
    C0205411 (UMLS CUI [3,4])
    C1705847 (UMLS CUI [4,1])
    C0553723 (UMLS CUI [4,2])
    C0920425 (UMLS CUI [4,3])
    C0205411 (UMLS CUI [4,4])
    C1705847 (UMLS CUI [5,1])
    C0851140 (UMLS CUI [5,2])
    C0920425 (UMLS CUI [5,3])
    C0205411 (UMLS CUI [5,4])
    Participation in another clinical trial
    Item
    current enrollment in or participation in another therapeutic clinical trial within 4 weeks preceding treatment start.
    boolean
    C2348568 (UMLS CUI [1,1])
    C0332185 (UMLS CUI [1,2])
    Other severe acute or chronic medical condition | other psychiatric condition | laboratory abnormality | disease interference with study protocol | disease increases risk for patient safety
    Item
    other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the patient inappropriate for entry into this study or could compromise protocol objectives in the opinion of the investigator and/or the sponsor.
    boolean
    C0001314 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C0521102 (UMLS CUI [1,4])
    C2348563 (UMLS CUI [1,5])
    C0001314 (UMLS CUI [2,1])
    C0205082 (UMLS CUI [2,2])
    C0205394 (UMLS CUI [2,3])
    C0035647 (UMLS CUI [2,4])
    C1113679 (UMLS CUI [2,5])
    C0008679 (UMLS CUI [3,1])
    C0205082 (UMLS CUI [3,2])
    C0205394 (UMLS CUI [3,3])
    C0521102 (UMLS CUI [3,4])
    C2348563 (UMLS CUI [3,5])
    C0008679 (UMLS CUI [4,1])
    C0205082 (UMLS CUI [4,2])
    C0205394 (UMLS CUI [4,3])
    C0035647 (UMLS CUI [4,4])
    C1113679 (UMLS CUI [4,5])
    C0004936 (UMLS CUI [5,1])
    C0521102 (UMLS CUI [5,2])
    C2348563 (UMLS CUI [5,3])
    C0004936 (UMLS CUI [6,1])
    C0035647 (UMLS CUI [6,2])
    C1113679 (UMLS CUI [6,3])
    C0438215 (UMLS CUI [7,1])
    C0521102 (UMLS CUI [7,2])
    C2348563 (UMLS CUI [7,3])
    C0438215 (UMLS CUI [8,1])
    C0035647 (UMLS CUI [8,2])
    C1113679 (UMLS CUI [8,3])
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