ID

39262

Beskrivning

Study of Lobaplatin,5-Fluorouracil and Leucovorin for the Treatment of Esophageal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01034683

Länk

https://clinicaltrials.gov/show/NCT01034683

Nyckelord

  1. 2019-12-13 2019-12-13 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

13 december 2019

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Esophageal Carcinoma NCT01034683

Eligibility Esophageal Carcinoma NCT01034683

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven squamous cell carcinoma of the esophagus(include cardiac cancer)
Beskrivning

Squamous cell carcinoma of esophagus | Cardiac Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0279626
UMLS CUI [2]
C1959584
newly diagnosed patients should be unable or unwilling to surgery
Beskrivning

Patients Newly Diagnosed | Operative Surgical Procedure Unable | Operative Surgical Procedure Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1518321
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C1299582
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0558080
recurrence after surgery must have no adjuvant chemotherapy or radiotherapy are allowed
Beskrivning

Recurrence Post Operative Surgical Procedure | Adjuvant Chemotherapy Absent | Adjuvant Radiation Therapy Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0034897
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0543467
UMLS CUI [2,1]
C0085533
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1706721
UMLS CUI [3,2]
C0332197
patients are required to have dimensionally measurable disease,with an objective measurable focus:preferably the use of spiral computed tomography(ct)and measurements of maximum diameter≥1cm.
Beskrivning

Measurable Disease Dimension Spiral Computed Tomography | Measurement Longest Diameter

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0439534
UMLS CUI [1,3]
C0860888
UMLS CUI [2,1]
C0242485
UMLS CUI [2,2]
C0552406
cooperative oncology group performance status 0-2 or kps score ≥60,survival time ≥3 months
Beskrivning

ECOG performance status | Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
neutrophils(anc)≥1.5×109/l; blood platelets counts(bpc)≥80×109/l
Beskrivning

Absolute neutrophil count | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
hemoglobin(hgb)≥90g/l ,serum total bilirubin ≤1.0 times the upper normal limit(uln): alanine aminotransferase and glutamic-oxalacetic transaminase (alt and ast)≤2.5 uln
Beskrivning

Hemoglobin measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
serum creatinine (cr)≤1.5uln
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or nursing women;
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
female patients at child-bearing age, without taking effective contraceptive methods;
Beskrivning

Childbearing Potential Contraceptive methods Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
patients who have pathologic confirmation of other types of tumors (eg, leiomyosarcoma, malignant lymphoma) rather than esophageal cancer;
Beskrivning

Cancer Other | Leiomyosarcoma | Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2]
C0023269
UMLS CUI [3]
C0024299
patients with tumors other than esophageal cancer ,except cervical carcinoma in situ and skin basal cancer or squamous cell carcinoma received adequate treatment;
Beskrivning

Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
patients with cerebral or meningeal metastasis, intestinal obstruction, or symptomatic pathologic changes of peripheral nerve,ncic-ctg standard >grade 2
Beskrivning

Cerebral metastasis | Metastatic Malignant Neoplasm to the Leptomeninges | Intestinal Obstruction | Peripheral Neuropathy Symptomatic CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1]
C0555278
UMLS CUI [2]
C1704231
UMLS CUI [3]
C0021843
UMLS CUI [4,1]
C0031117
UMLS CUI [4,2]
C0231220
UMLS CUI [4,3]
C1516728
patients with serious complications such as: serious heart disease remained unstable after treatment, or myocardial infarction, congestive heart failure, unstable angina, frank pericardial effusion or unstable arrhythmias in 6 months before being enrolled into the group; confirmed neuropathy or psychosis, including dementia or epilepsia; uncontrolled infection;active disseminated intravascular coagulation;uncontrolled diabetes, fasting serum glucose> 7.8mmol / l
Beskrivning

Complications Serious | Heart Disease Serious | Unstable status Post Therapeutic procedure | Myocardial Infarction | Congestive heart failure | Angina, Unstable | Pericardial effusion | Cardiac Arrhythmia Unstable | Neuropathy | Psychotic Disorder | Dementia | Epilepsy | Communicable Disease Uncontrolled | Disseminated Intravascular Coagulation | Diabetic - poor control | Serum fasting glucose measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C0443343
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C0087111
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0018802
UMLS CUI [6]
C0002965
UMLS CUI [7]
C0031039
UMLS CUI [8,1]
C0003811
UMLS CUI [8,2]
C0443343
UMLS CUI [9]
C0442874
UMLS CUI [10]
C0033975
UMLS CUI [11]
C0497327
UMLS CUI [12]
C0014544
UMLS CUI [13,1]
C0009450
UMLS CUI [13,2]
C0205318
UMLS CUI [14]
C0012739
UMLS CUI [15]
C0421258
UMLS CUI [16]
C0583334

Similar models

Eligibility Esophageal Carcinoma NCT01034683

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of esophagus | Cardiac Carcinoma
Item
histologically proven squamous cell carcinoma of the esophagus(include cardiac cancer)
boolean
C0279626 (UMLS CUI [1])
C1959584 (UMLS CUI [2])
Patients Newly Diagnosed | Operative Surgical Procedure Unable | Operative Surgical Procedure Unwilling
Item
newly diagnosed patients should be unable or unwilling to surgery
boolean
C0030705 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
Recurrence Post Operative Surgical Procedure | Adjuvant Chemotherapy Absent | Adjuvant Radiation Therapy Absent
Item
recurrence after surgery must have no adjuvant chemotherapy or radiotherapy are allowed
boolean
C0034897 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0085533 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1706721 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Measurable Disease Dimension Spiral Computed Tomography | Measurement Longest Diameter
Item
patients are required to have dimensionally measurable disease,with an objective measurable focus:preferably the use of spiral computed tomography(ct)and measurements of maximum diameter≥1cm.
boolean
C1513041 (UMLS CUI [1,1])
C0439534 (UMLS CUI [1,2])
C0860888 (UMLS CUI [1,3])
C0242485 (UMLS CUI [2,1])
C0552406 (UMLS CUI [2,2])
ECOG performance status | Karnofsky Performance Status
Item
cooperative oncology group performance status 0-2 or kps score ≥60,survival time ≥3 months
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Absolute neutrophil count | Platelet Count measurement
Item
neutrophils(anc)≥1.5×109/l; blood platelets counts(bpc)≥80×109/l
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Hemoglobin measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
hemoglobin(hgb)≥90g/l ,serum total bilirubin ≤1.0 times the upper normal limit(uln): alanine aminotransferase and glutamic-oxalacetic transaminase (alt and ast)≤2.5 uln
boolean
C0518015 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
Creatinine measurement, serum
Item
serum creatinine (cr)≤1.5uln
boolean
C0201976 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or nursing women;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Absent
Item
female patients at child-bearing age, without taking effective contraceptive methods;
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Cancer Other | Leiomyosarcoma | Lymphoma
Item
patients who have pathologic confirmation of other types of tumors (eg, leiomyosarcoma, malignant lymphoma) rather than esophageal cancer;
boolean
C1707251 (UMLS CUI [1])
C0023269 (UMLS CUI [2])
C0024299 (UMLS CUI [3])
Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
patients with tumors other than esophageal cancer ,except cervical carcinoma in situ and skin basal cancer or squamous cell carcinoma received adequate treatment;
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Cerebral metastasis | Metastatic Malignant Neoplasm to the Leptomeninges | Intestinal Obstruction | Peripheral Neuropathy Symptomatic CTCAE Grades
Item
patients with cerebral or meningeal metastasis, intestinal obstruction, or symptomatic pathologic changes of peripheral nerve,ncic-ctg standard >grade 2
boolean
C0555278 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
C0021843 (UMLS CUI [3])
C0031117 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
C1516728 (UMLS CUI [4,3])
Complications Serious | Heart Disease Serious | Unstable status Post Therapeutic procedure | Myocardial Infarction | Congestive heart failure | Angina, Unstable | Pericardial effusion | Cardiac Arrhythmia Unstable | Neuropathy | Psychotic Disorder | Dementia | Epilepsy | Communicable Disease Uncontrolled | Disseminated Intravascular Coagulation | Diabetic - poor control | Serum fasting glucose measurement
Item
patients with serious complications such as: serious heart disease remained unstable after treatment, or myocardial infarction, congestive heart failure, unstable angina, frank pericardial effusion or unstable arrhythmias in 6 months before being enrolled into the group; confirmed neuropathy or psychosis, including dementia or epilepsia; uncontrolled infection;active disseminated intravascular coagulation;uncontrolled diabetes, fasting serum glucose> 7.8mmol / l
boolean
C0009566 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0443343 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0027051 (UMLS CUI [4])
C0018802 (UMLS CUI [5])
C0002965 (UMLS CUI [6])
C0031039 (UMLS CUI [7])
C0003811 (UMLS CUI [8,1])
C0443343 (UMLS CUI [8,2])
C0442874 (UMLS CUI [9])
C0033975 (UMLS CUI [10])
C0497327 (UMLS CUI [11])
C0014544 (UMLS CUI [12])
C0009450 (UMLS CUI [13,1])
C0205318 (UMLS CUI [13,2])
C0012739 (UMLS CUI [14])
C0421258 (UMLS CUI [15])
C0583334 (UMLS CUI [16])

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