ID

35859

Beschreibung

Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal Squamous Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02384811

Link

https://clinicaltrials.gov/show/NCT02384811

Stichworte

Versionen (1)
  1. 28.03.19 28.03.19 -
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See clinicaltrials.gov

Hochgeladen am

28. März 2019

DOI

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Eligibility Esophageal Squamous Cell Carcinoma NCT02384811

Englisch

Eligibility Esophageal Squamous Cell Carcinoma NCT02384811

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
joined the study voluntarily and signed informed consent form;
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
age 18-75；ecog 0-2
Beschreibung

Age | ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1520224
esophageal squamous cell carcinoma , radical surgery ≤3 months,r0 resection. the operative incision healed well.
Beschreibung

Squamous cell carcinoma of esophagus | Operative Surgical Procedure Radical | Excision TNM clinical staging | Well-healed incision

Datentyp

boolean

Alias
UMLS CUI [1]
C0279626
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0439807
UMLS CUI [3,1]
C0728940
UMLS CUI [3,2]
C3258246
UMLS CUI [4]
C2116737
t3-4n0m0, t1-4n1-3m0 (according to ajcc2009)
Beschreibung

TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1]
C3258246
no radiotherapy, chemotherapy or other treatments pre(post)surgery
Beschreibung

Therapeutic radiology procedure Absent | Chemotherapy Absent | Therapy Preoperative Absent | Therapy Postoperative Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0445204
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0032790
UMLS CUI [4,3]
C0332197
ps ecog 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of more than 3 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
hemoglobin(hb)≥9 g/dl • wbc≥3x109/l, neutrophils (anc )≥1.5x109/l • platelet count (pt) ≥100x 109/l • hepatic function: alat and asat < 2.5 x uln, tbil<1.5 x uln •
Beschreibung

Hemoglobin measurement | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Liver function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0232741
UMLS CUI [6]
C0201836
UMLS CUI [7]
C0201899
UMLS CUI [8]
C1278039
renal function: creatinine < 1.5 x uln
Beschreibung

Renal function | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
no immuno-deficiency
Beschreibung

Immunodeficiency Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021051
UMLS CUI [1,2]
C0332197
use of an effective contraceptive for adults to prevent pregnancy.
Beschreibung

Adult Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001675
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
complete esophageal obstruction after surgery, esophageal perforation, haematemesis
Beschreibung

ESOPHAGEAL OBSTRUCTION COMPLETE Post Operative Surgical Procedures | Esophageal Perforation | Hematemesis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0743579
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0543467
UMLS CUI [2]
C0014860
UMLS CUI [3]
C0018926
other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
Beschreibung

Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Disease Free Duration

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C0332296
UMLS CUI [4,4]
C0449238
participation in other interventional clinical trials within 30 days
Beschreibung

Study Subject Participation Status | Interventional clinical trial

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3274035
pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
Beschreibung

Pregnancy | Breast Feeding | Birth Period Contraceptive methods Refused

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0005615
UMLS CUI [3,2]
C1948053
UMLS CUI [3,3]
C0700589
UMLS CUI [3,4]
C1705116
drug addiction, alcoholism or aids
Beschreibung

Drug Dependence | Alcoholic Intoxication, Chronic | AIDS

Datentyp

boolean

Alias
UMLS CUI [1]
C1510472
UMLS CUI [2]
C0001973
UMLS CUI [3]
C0001175
uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
Beschreibung

Seizures Uncontrolled | Mental disorders Uncontrolled | Uncontrolled behavior

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0474399
unsuitable to be enrolled in the trial in the opinion of the investigators
Beschreibung

Study Subject Participation Status Inappropriate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Ähnliche Modelle

Eligibility Esophageal Squamous Cell Carcinoma NCT02384811

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
joined the study voluntarily and signed informed consent form;
boolean
C0021430 (UMLS CUI [1])
Age | ECOG performance status
Item
age 18-75；ecog 0-2
boolean
C0001779 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Squamous cell carcinoma of esophagus | Operative Surgical Procedure Radical | Excision TNM clinical staging | Well-healed incision
Item
esophageal squamous cell carcinoma , radical surgery ≤3 months,r0 resection. the operative incision healed well.
boolean
C0279626 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0439807 (UMLS CUI [2,2])
C0728940 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
C2116737 (UMLS CUI [4])
TNM clinical staging
Item
t3-4n0m0, t1-4n1-3m0 (according to ajcc2009)
boolean
C3258246 (UMLS CUI [1])
Therapeutic radiology procedure Absent | Chemotherapy Absent | Therapy Preoperative Absent | Therapy Postoperative Absent
Item
no radiotherapy, chemotherapy or other treatments pre(post)surgery
boolean
C1522449 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0445204 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C0032790 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
ECOG performance status
Item
ps ecog 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of more than 3 months
boolean
C0023671 (UMLS CUI [1])
Hemoglobin measurement | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Liver function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement
Item
hemoglobin(hb)≥9 g/dl • wbc≥3x109/l, neutrophils (anc )≥1.5x109/l • platelet count (pt) ≥100x 109/l • hepatic function: alat and asat < 2.5 x uln, tbil<1.5 x uln •
boolean
C0518015 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0232741 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0201899 (UMLS CUI [7])
C1278039 (UMLS CUI [8])
Renal function | Creatinine measurement, serum
Item
renal function: creatinine < 1.5 x uln
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Immunodeficiency Absent
Item
no immuno-deficiency
boolean
C0021051 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Adult Contraceptive methods
Item
use of an effective contraceptive for adults to prevent pregnancy.
boolean
C0001675 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
ESOPHAGEAL OBSTRUCTION COMPLETE Post Operative Surgical Procedures | Esophageal Perforation | Hematemesis
Item
complete esophageal obstruction after surgery, esophageal perforation, haematemesis
boolean
C0743579 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0014860 (UMLS CUI [2])
C0018926 (UMLS CUI [3])
Cancer Other | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Disease Free Duration
Item
other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0332296 (UMLS CUI [4,3])
C0449238 (UMLS CUI [4,4])
Study Subject Participation Status | Interventional clinical trial
Item
participation in other interventional clinical trials within 30 days
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
Pregnancy | Breast Feeding | Birth Period Contraceptive methods Refused
Item
pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0005615 (UMLS CUI [3,1])
C1948053 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C1705116 (UMLS CUI [3,4])
Drug Dependence | Alcoholic Intoxication, Chronic | AIDS
Item
drug addiction, alcoholism or aids
boolean
C1510472 (UMLS CUI [1])
C0001973 (UMLS CUI [2])
C0001175 (UMLS CUI [3])
Seizures Uncontrolled | Mental disorders Uncontrolled | Uncontrolled behavior
Item
uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
boolean
C0036572 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0474399 (UMLS CUI [3])
Study Subject Participation Status Inappropriate
Item
unsuitable to be enrolled in the trial in the opinion of the investigators
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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