ID

37236

Beschrijving

Chemoradiotherapy of Capecitabine With or Without Oxaliplatin Versus Cisplatin-5-FU for Esophageal Squamous Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02025036

Link

https://clinicaltrials.gov/show/NCT02025036

Trefwoorden

Versies (1)
  1. 10-07-19 10-07-19 -
Houder van rechten

See clinicaltrials.gov

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10 juli 2019

DOI

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Creative Commons BY 4.0
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Eligibility Stage III Esophageal Squamous Cell Carcinoma NCT02025036

Engels

Eligibility Stage III Esophageal Squamous Cell Carcinoma NCT02025036

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 45-75years old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
histologically proven squamous cell carcinoma of the esophagus
Beschrijving

Squamous cell carcinoma of esophagus

Datatype

boolean

Alias
UMLS CUI [1]
C0279626
the tumor was in t2-4n0-1m0
Beschrijving

Tumor TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C3258246
the patients have not received the surgery or chemo-radiotherapy.
Beschrijving

Operative Surgical Procedures Absent | Chemoradiotherapy Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0436307
UMLS CUI [2,2]
C0332197
hb≥80g/l, absolute neutrophil count ≥1.5×109/l, plt≥90×109/l,
Beschrijving

Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
alt、ast≤2.5*n,cr≤1.5*n.
Beschrijving

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201976
performance status score 0-2
Beschrijving

Performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1518965
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant, lactating women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
oxaliplatin or fluorouracil allergy or metabolic disorders
Beschrijving

Hypersensitivity Oxaliplatin | Fluorouracil allergy | Metabolic Diseases

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0069717
UMLS CUI [2]
C0570698
UMLS CUI [3]
C0025517
radiotherapy contraindications
Beschrijving

Medical contraindication Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1522449
history of organ transplantation
Beschrijving

Organ Transplantation

Datatype

boolean

Alias
UMLS CUI [1]
C0029216
brain metastasis
Beschrijving

Metastatic malignant neoplasm to brain

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
the peripheral nervous system disorders
Beschrijving

Peripheral Nervous System Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0206417
UMLS CUI [1,2]
C0012634
severe infection
Beschrijving

Communicable Disease Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
oral capecitabine who have difficulty with,such as dysphagia,the activities of digestive ulcer, gastrointestinal bleeding
Beschrijving

Difficulty with Oral capecitabine | Deglutition Disorders | Ulcer Digestive | Gastrointestinal Hemorrhage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332218
UMLS CUI [1,2]
C3213270
UMLS CUI [2]
C0011168
UMLS CUI [3,1]
C0041582
UMLS CUI [3,2]
C0012238
UMLS CUI [4]
C0017181
severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes.
Beschrijving

Chronic disease Severe | Liver disease | Kidney Disease | Respiration Disorder | Hypertensive disease | Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0035204
UMLS CUI [5]
C0020538
UMLS CUI [6]
C0011849
other malignant tumor in recent 5 years.
Beschrijving

Cancer Other

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
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Similar models

Eligibility Stage III Esophageal Squamous Cell Carcinoma NCT02025036

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 45-75years old
boolean
C0001779 (UMLS CUI [1])
Squamous cell carcinoma of esophagus
Item
histologically proven squamous cell carcinoma of the esophagus
boolean
C0279626 (UMLS CUI [1])
Tumor TNM clinical staging
Item
the tumor was in t2-4n0-1m0
boolean
C0027651 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Operative Surgical Procedures Absent | Chemoradiotherapy Absent
Item
the patients have not received the surgery or chemo-radiotherapy.
boolean
C0543467 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0436307 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Hemoglobin measurement | Absolute neutrophil count | Platelet Count measurement
Item
hb≥80g/l, absolute neutrophil count ≥1.5×109/l, plt≥90×109/l,
boolean
C0518015 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Creatinine measurement, serum
Item
alt、ast≤2.5*n,cr≤1.5*n.
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
Performance status
Item
performance status score 0-2
boolean
C1518965 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant, lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Oxaliplatin | Fluorouracil allergy | Metabolic Diseases
Item
oxaliplatin or fluorouracil allergy or metabolic disorders
boolean
C0020517 (UMLS CUI [1,1])
C0069717 (UMLS CUI [1,2])
C0570698 (UMLS CUI [2])
C0025517 (UMLS CUI [3])
Medical contraindication Therapeutic radiology procedure
Item
radiotherapy contraindications
boolean
C1301624 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Organ Transplantation
Item
history of organ transplantation
boolean
C0029216 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
brain metastasis
boolean
C0220650 (UMLS CUI [1])
Peripheral Nervous System Disease
Item
the peripheral nervous system disorders
boolean
C0206417 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Communicable Disease Severe
Item
severe infection
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Difficulty with Oral capecitabine | Deglutition Disorders | Ulcer Digestive | Gastrointestinal Hemorrhage
Item
oral capecitabine who have difficulty with,such as dysphagia,the activities of digestive ulcer, gastrointestinal bleeding
boolean
C0332218 (UMLS CUI [1,1])
C3213270 (UMLS CUI [1,2])
C0011168 (UMLS CUI [2])
C0041582 (UMLS CUI [3,1])
C0012238 (UMLS CUI [3,2])
C0017181 (UMLS CUI [4])
Chronic disease Severe | Liver disease | Kidney Disease | Respiration Disorder | Hypertensive disease | Diabetes Mellitus
Item
severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes.
boolean
C0008679 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0035204 (UMLS CUI [4])
C0020538 (UMLS CUI [5])
C0011849 (UMLS CUI [6])
Cancer Other
Item
other malignant tumor in recent 5 years.
boolean
C1707251 (UMLS CUI [1])
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