ID

32573

Descripción

Paclitaxel and Cisplatin for Thymic Neoplasm; ODM derived from: https://clinicaltrials.gov/show/NCT00818090

Link

https://clinicaltrials.gov/show/NCT00818090

Palabras clave

Versiones (1)
  1. 7/11/18 7/11/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

7 de noviembre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Thymoma NCT00818090

Inglés

Eligibility Thymoma NCT00818090

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Thymoma NCT00818090
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed invasive thymoma or thymic carcinoma
Descripción

Thymoma invasive | Thymic Carcinoma Invasive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0278846
UMLS CUI [2,1]
C0205969
UMLS CUI [2,2]
C0205281
unresectable tumor: by either local invasion, distant metastasis, or recurred (assessed by investigator)
Descripción

Tumor surgically unresectable | Local tumor invasion | Distant metastasis | Recurrent tumor

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4039777
UMLS CUI [2]
C1300092
UMLS CUI [3]
C1269798
UMLS CUI [4]
C0521158
no previous systemic treatment for invasive thymoma or thymic carcinoma
Descripción

Absence Systemic therapy Thymoma invasive | Absence Systemic therapy Thymic Carcinoma invasive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1515119
UMLS CUI [1,3]
C0278846
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C1515119
UMLS CUI [2,3]
C0205969
UMLS CUI [2,4]
C0205281
at least one measurable lesion by recist criteria
Descripción

Measurable lesion Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
18 years old or older
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status 0, 1, 2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
adequate lab. findings neutrophil ≥ 1.5 x 10^9/l platelet ≥ 75 x 10^9/l hemoglobin ≥
Descripción

Laboratory findings | Neutrophil count | Platelet Count measurement | Hemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0587081
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
9.0 g/dl bilirubin ≤ 1.5 x upper normal limit ast, alt ≤ 2.5 x upper normal limit alkaline phosphatase ≤ 2.5 x upper normal limit (if liver metastasis, ≤ 5 x upper normal limit) serum creatinine ≤ 1.0 x upper normal limit if serum creatinine > 1.0 x upper normal limit, creatinine clearance ≥ 60 ml/min
Descripción

Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Secondary malignant neoplasm of liver | Creatinine measurement, serum | Creatinine clearance measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201850
UMLS CUI [5]
C0494165
UMLS CUI [6]
C0201976
UMLS CUI [7]
C0373595
patient who agree to written, informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
other malignancy (exception: non-melanoma skin cancer, cervical carcinoma in situ, cancer without evidence more than 5 years since curative resection)
Descripción

Cancer Other | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Excision Curative Malignant Neoplasm | Exception Disease Free of

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0728940
UMLS CUI [4,3]
C1276305
UMLS CUI [4,4]
C0006826
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0332296
active bacterial infection
Descripción

Bacterial Infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004623
history of clinical trial with investigational drug within 30 days
Descripción

Study Subject Participation Status | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
radiotherapy to thoracic or mediastinal area (other area radiotherapy is permitted)
Descripción

Radiotherapy to thorax | Radiotherapy to mediastinum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4038705
UMLS CUI [2]
C4049191
pregnant, or lactating women
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient with organ transplantation
Descripción

Organ Transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0029216
peripheral neuropathy, grade 2 or greater
Descripción

Peripheral Neuropathy CTCAE Grades

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
severe, medical condition unstable cardiac disease despite of adequate management myocardial infarction within 6 months active ulcer disease refractory to medication chronic obstructive lung disease requiring admission treatment within 1 year
Descripción

Medical condition Severe | Heart Disease Unstable | Management Adequate | Myocardial Infarction | Peptic Ulcer Refractory Pharmaceutical Preparations | Chronic Obstructive Airway Disease Requirement Admission for treatment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0376636
UMLS CUI [3,2]
C0205411
UMLS CUI [4]
C0027051
UMLS CUI [5,1]
C0030920
UMLS CUI [5,2]
C0205269
UMLS CUI [5,3]
C0013227
UMLS CUI [6,1]
C0024117
UMLS CUI [6,2]
C1514873
UMLS CUI [6,3]
C0582450
uncontrolled seizure, cerebral nervous system disorder, psychiatric problem which decrease treatment compliance
Descripción

Seizure Uncontrolled Decreasing Treatment Compliance | Nervous system disorder cerebral Decreasing Treatment Compliance | Psychiatric problem Decreasing Treatment Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0442797
UMLS CUI [1,4]
C4319828
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0006104
UMLS CUI [2,3]
C0442797
UMLS CUI [2,4]
C4319828
UMLS CUI [3,1]
C1306597
UMLS CUI [3,2]
C0442797
UMLS CUI [3,3]
C4319828
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Similar models

Eligibility Thymoma NCT00818090

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Thymoma NCT00818090
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Thymoma invasive | Thymic Carcinoma Invasive
Item
histologically or cytologically confirmed invasive thymoma or thymic carcinoma
boolean
C0278846 (UMLS CUI [1])
C0205969 (UMLS CUI [2,1])
C0205281 (UMLS CUI [2,2])
Tumor surgically unresectable | Local tumor invasion | Distant metastasis | Recurrent tumor
Item
unresectable tumor: by either local invasion, distant metastasis, or recurred (assessed by investigator)
boolean
C4039777 (UMLS CUI [1])
C1300092 (UMLS CUI [2])
C1269798 (UMLS CUI [3])
C0521158 (UMLS CUI [4])
Absence Systemic therapy Thymoma invasive | Absence Systemic therapy Thymic Carcinoma invasive
Item
no previous systemic treatment for invasive thymoma or thymic carcinoma
boolean
C0332197 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
C0278846 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C1515119 (UMLS CUI [2,2])
C0205969 (UMLS CUI [2,3])
C0205281 (UMLS CUI [2,4])
Measurable lesion Quantity
Item
at least one measurable lesion by recist criteria
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Age
Item
18 years old or older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0, 1, 2
boolean
C1520224 (UMLS CUI [1])
Laboratory findings | Neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
adequate lab. findings neutrophil ≥ 1.5 x 10^9/l platelet ≥ 75 x 10^9/l hemoglobin ≥
boolean
C0587081 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Secondary malignant neoplasm of liver | Creatinine measurement, serum | Creatinine clearance measurement
Item
9.0 g/dl bilirubin ≤ 1.5 x upper normal limit ast, alt ≤ 2.5 x upper normal limit alkaline phosphatase ≤ 2.5 x upper normal limit (if liver metastasis, ≤ 5 x upper normal limit) serum creatinine ≤ 1.0 x upper normal limit if serum creatinine > 1.0 x upper normal limit, creatinine clearance ≥ 60 ml/min
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C0494165 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C0373595 (UMLS CUI [7])
Informed Consent
Item
patient who agree to written, informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Excision Curative Malignant Neoplasm | Exception Disease Free of
Item
other malignancy (exception: non-melanoma skin cancer, cervical carcinoma in situ, cancer without evidence more than 5 years since curative resection)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0728940 (UMLS CUI [4,2])
C1276305 (UMLS CUI [4,3])
C0006826 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
Bacterial Infection
Item
active bacterial infection
boolean
C0004623 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
history of clinical trial with investigational drug within 30 days
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Radiotherapy to thorax | Radiotherapy to mediastinum
Item
radiotherapy to thoracic or mediastinal area (other area radiotherapy is permitted)
boolean
C4038705 (UMLS CUI [1])
C4049191 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant, or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Organ Transplantation
Item
patient with organ transplantation
boolean
C0029216 (UMLS CUI [1])
Peripheral Neuropathy CTCAE Grades
Item
peripheral neuropathy, grade 2 or greater
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Medical condition Severe | Heart Disease Unstable | Management Adequate | Myocardial Infarction | Peptic Ulcer Refractory Pharmaceutical Preparations | Chronic Obstructive Airway Disease Requirement Admission for treatment
Item
severe, medical condition unstable cardiac disease despite of adequate management myocardial infarction within 6 months active ulcer disease refractory to medication chronic obstructive lung disease requiring admission treatment within 1 year
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0376636 (UMLS CUI [3,1])
C0205411 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
C0030920 (UMLS CUI [5,1])
C0205269 (UMLS CUI [5,2])
C0013227 (UMLS CUI [5,3])
C0024117 (UMLS CUI [6,1])
C1514873 (UMLS CUI [6,2])
C0582450 (UMLS CUI [6,3])
Seizure Uncontrolled Decreasing Treatment Compliance | Nervous system disorder cerebral Decreasing Treatment Compliance | Psychiatric problem Decreasing Treatment Compliance
Item
uncontrolled seizure, cerebral nervous system disorder, psychiatric problem which decrease treatment compliance
boolean
C0036572 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0442797 (UMLS CUI [1,3])
C4319828 (UMLS CUI [1,4])
C0027765 (UMLS CUI [2,1])
C0006104 (UMLS CUI [2,2])
C0442797 (UMLS CUI [2,3])
C4319828 (UMLS CUI [2,4])
C1306597 (UMLS CUI [3,1])
C0442797 (UMLS CUI [3,2])
C4319828 (UMLS CUI [3,3])
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