ID

32474

Beschreibung

Phase III Study of Neo-adjuvant Chemoradiotherapy Followed by Surgery for Squamous Cell Esophageal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01216527

Link

https://clinicaltrials.gov/show/NCT01216527

Stichworte

Versionen (1)
  1. 02.11.18 02.11.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

2. November 2018

DOI

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Eligibility Squamous Cell Esophageal Carcinoma NCT01216527

Englisch

Eligibility Squamous Cell Esophageal Carcinoma NCT01216527

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologic diagnosis of squamous cell thoracic esophageal carcinoma of stage iib or iii, which is potentially resectable.
Beschreibung

Squamous cell carcinoma of esophagus Thoracic Resectable TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279626
UMLS CUI [1,2]
C0817096
UMLS CUI [1,3]
C1514888
UMLS CUI [1,4]
C3258246
2. patients must not have received any prior anticancer therapy.
Beschreibung

Cancer treatment Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0332197
3. more than 6 months of expected survival.
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
4. age ranges from 18 to 70 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
5. absolute white blood cells count ≥4.0×109/l, neutrophil ≥1.5×109/l, platelets
Beschreibung

White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0032181
≥100.0×109/l, hemoglobin ≥90g/l, and normal functions of liver and kidney.
Beschreibung

Hemoglobin measurement | Liver function | Renal function

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
6. karnofsky performance status (kps) of 90 or more.
Beschreibung

Karnofsky Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
7. signed informed consent document on file.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients are diagnosed or suspected to be allergic to cisplatin or vinorelbine.
Beschreibung

Cisplatin allergy | Cisplatin allergy Suspected | Hypersensitivity Vinorelbine | Hypersensitivity Suspected Vinorelbine

Datentyp

boolean

Alias
UMLS CUI [1]
C0570702
UMLS CUI [2,1]
C0570702
UMLS CUI [2,2]
C0750491
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0078257
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0078257
2. patients with concomitant hemorrhagic disease.
Beschreibung

Hemorrhagic Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0019087
3. pregnant or breast feeding.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
4. inability to use gastric conduit after esophagectomy because of a prior surgery.
Beschreibung

Use of Conduit gastric Unable | Status post Esophagectomy | Etiology Operative Surgical Procedures Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0441247
UMLS CUI [1,3]
C0038351
UMLS CUI [1,4]
C1299582
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0085198
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0543467
UMLS CUI [3,3]
C0205156
5. patients with concomitant peripheral neuropathy, whose ctc status is 2 or even more.
Beschreibung

Peripheral Neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
6. have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.
Beschreibung

Malignant Neoplasms | Exception Esophageal carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma | Exception Prostate carcinoma Early stage Cured

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0152018
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0699893
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0600139
UMLS CUI [5,3]
C2363430
UMLS CUI [5,4]
C0679252
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Ähnliche Modelle

Eligibility Squamous Cell Esophageal Carcinoma NCT01216527

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of esophagus Thoracic Resectable TNM clinical staging
Item
1. histologic diagnosis of squamous cell thoracic esophageal carcinoma of stage iib or iii, which is potentially resectable.
boolean
C0279626 (UMLS CUI [1,1])
C0817096 (UMLS CUI [1,2])
C1514888 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
Cancer treatment Absent
Item
2. patients must not have received any prior anticancer therapy.
boolean
C0920425 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Life Expectancy
Item
3. more than 6 months of expected survival.
boolean
C0023671 (UMLS CUI [1])
Age
Item
4. age ranges from 18 to 70 years.
boolean
C0001779 (UMLS CUI [1])
White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement
Item
5. absolute white blood cells count ≥4.0×109/l, neutrophil ≥1.5×109/l, platelets
boolean
C0023508 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Hemoglobin measurement | Liver function | Renal function
Item
≥100.0×109/l, hemoglobin ≥90g/l, and normal functions of liver and kidney.
boolean
C0518015 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Karnofsky Performance Status
Item
6. karnofsky performance status (kps) of 90 or more.
boolean
C0206065 (UMLS CUI [1])
Informed Consent
Item
7. signed informed consent document on file.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cisplatin allergy | Cisplatin allergy Suspected | Hypersensitivity Vinorelbine | Hypersensitivity Suspected Vinorelbine
Item
1. patients are diagnosed or suspected to be allergic to cisplatin or vinorelbine.
boolean
C0570702 (UMLS CUI [1])
C0570702 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0078257 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0078257 (UMLS CUI [4,3])
Hemorrhagic Disorder
Item
2. patients with concomitant hemorrhagic disease.
boolean
C0019087 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
3. pregnant or breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Use of Conduit gastric Unable | Status post Esophagectomy | Etiology Operative Surgical Procedures Previous
Item
4. inability to use gastric conduit after esophagectomy because of a prior surgery.
boolean
C1524063 (UMLS CUI [1,1])
C0441247 (UMLS CUI [1,2])
C0038351 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C0231290 (UMLS CUI [2,1])
C0085198 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0205156 (UMLS CUI [3,3])
Peripheral Neuropathy CTCAE Grades
Item
5. patients with concomitant peripheral neuropathy, whose ctc status is 2 or even more.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Esophageal carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma | Exception Prostate carcinoma Early stage Cured
Item
6. have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0152018 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0699893 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0600139 (UMLS CUI [5,2])
C2363430 (UMLS CUI [5,3])
C0679252 (UMLS CUI [5,4])
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