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])
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])