ID

42325

Description

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

Link

https://clinicaltrials.gov/show/NCT02049047

Keywords

Versions (2)
  1. 5/28/21 5/28/21 -
  2. 6/11/21 6/11/21 -
Copyright Holder

Armando Santoro, MD, Istituto Clinico Humanitas, Rozzano

Uploaded on

June 11, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Thymoma and Thymic Carcinoma NCT02049047

English

Eligibility Thymoma and Thymic Carcinoma NCT02049047

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

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

Data type

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
Description

Prior platinum-based chemotherapy | documented progressive disease

Data type

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
Description

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

Data type

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)
Description

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

Data type

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
Description

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

Data type

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
Description

Life Expectancy

Data type

boolean

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

ECOG performance status

Data type

boolean

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

Negative pregnancy test

Data type

boolean

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

Organ function adequate | marrow function adequate

Data type

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
Description

Haematology and clinical chemistry thresholds

Data type

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
Description

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.
Description

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

Data type

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
Description

Recent major surgery | excl. diagnostic surgery

Data type

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
Description

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

Data type

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
Description

Pregnancy or breast feeding

Data type

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
Description

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

Data type

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.
Description

Participation in another clinical trial

Data type

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.
Description

Other severe acute or chronic medical condition | other psychiatric condition | laboratory abnormality | disease interference with study protocol | disease increases risk for patient safety

Data type

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
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Similar models

Eligibility Thymoma and Thymic Carcinoma NCT02049047

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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