ID

31018

Beskrivning

Phase Ⅱ Study of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage ⅣAB Nasopharyngeal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00816816

Länk

https://clinicaltrials.gov/show/NCT00816816

Nyckelord

Versioner (1)
  1. 2018-07-11 2018-07-11 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

11 juli 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Nasopharyngeal Carcinoma NCT00816816

Engelsk

Eligibility Nasopharyngeal Carcinoma NCT00816816

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically proven differentiated non-keratinizing carcinoma, and undifferentiated carcinoma of the nasopharynx.
Beskrivning

Nasopharyngeal Nonkeratinizing Differentiated Carcinoma | Undifferentiated carcinoma of nasopharynx

Datatyp

boolean

Alias
UMLS CUI [1]
C1709153
UMLS CUI [2]
C0279748
stage ⅳab disease
Beskrivning

TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1]
C3258246
kps >70
Beskrivning

Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
age between 18-70
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (agc) of > 2000 cells/mm3, platelet count of > 100,000 cells/mm3 (pre treatment without intervention). bilirubin < 1.5 mg/dl, ast or alt<2 x upper normal, serum creatinine<1.5mg/dl, creatinine clearance >50ml/min.
Beskrivning

Bone Marrow function | Absolute neutrophil count Peripheral blood | Platelet Count measurement | Pretreatment Without Intervention | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum | Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2,1]
C0948762
UMLS CUI [2,2]
C0229664
UMLS CUI [3]
C0032181
UMLS CUI [4,1]
C3539076
UMLS CUI [4,2]
C0332288
UMLS CUI [4,3]
C0184661
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201836
UMLS CUI [8]
C0201976
UMLS CUI [9]
C0373595
no prior radiation treatment to the head and neck or any prior chemotherapy
Beskrivning

Radiation therapy to the head and neck Absent | Prior Chemotherapy Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4540910
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0332197
patients with no prior malignancy (not include basal cell carcinoma of skin)
Beskrivning

Malignant Neoplasms Previous Absent | Exception Basal cell carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
Beskrivning

Neoplasm Metastasis below Clavicle Clinical examination | Distant metastasis Clinical examination | Neoplasm Metastasis below Clavicle Radiography | Distant metastasis Radiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0542339
UMLS CUI [1,3]
C0008913
UMLS CUI [1,4]
C1456356
UMLS CUI [2,1]
C1269798
UMLS CUI [2,2]
C1456356
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0542339
UMLS CUI [3,3]
C0008913
UMLS CUI [3,4]
C0043299
UMLS CUI [4,1]
C1269798
UMLS CUI [4,2]
C0043299
prior radiotherapy to the head and neck region for any reason.
Beskrivning

Radiation therapy to the head and neck Reason Any

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4540910
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1552551
initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
Beskrivning

Operative Surgical Procedures Initial | Exception Biopsy Primary tumor site | Exception Biopsy Disorder of neck

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205265
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0005558
UMLS CUI [2,3]
C0475447
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0005558
UMLS CUI [3,3]
C0558385
patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin.
Beskrivning

Primary tumor | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Datatyp

boolean

Alias
UMLS CUI [1]
C0677930
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
pregnant women
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Nasopharyngeal Carcinoma NCT00816816

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Nasopharyngeal Nonkeratinizing Differentiated Carcinoma | Undifferentiated carcinoma of nasopharynx
Item
histologically proven differentiated non-keratinizing carcinoma, and undifferentiated carcinoma of the nasopharynx.
boolean
C1709153 (UMLS CUI [1])
C0279748 (UMLS CUI [2])
TNM clinical staging
Item
stage ⅳab disease
boolean
C3258246 (UMLS CUI [1])
Karnofsky Performance Status
Item
kps >70
boolean
C0206065 (UMLS CUI [1])
Age
Item
age between 18-70
boolean
C0001779 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count Peripheral blood | Platelet Count measurement | Pretreatment Without Intervention | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum | Creatinine clearance measurement
Item
patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (agc) of > 2000 cells/mm3, platelet count of > 100,000 cells/mm3 (pre treatment without intervention). bilirubin < 1.5 mg/dl, ast or alt<2 x upper normal, serum creatinine<1.5mg/dl, creatinine clearance >50ml/min.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2,1])
C0229664 (UMLS CUI [2,2])
C0032181 (UMLS CUI [3])
C3539076 (UMLS CUI [4,1])
C0332288 (UMLS CUI [4,2])
C0184661 (UMLS CUI [4,3])
C1278039 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
C0373595 (UMLS CUI [9])
Radiation therapy to the head and neck Absent | Prior Chemotherapy Absent
Item
no prior radiation treatment to the head and neck or any prior chemotherapy
boolean
C4540910 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Malignant Neoplasms Previous Absent | Exception Basal cell carcinoma
Item
patients with no prior malignancy (not include basal cell carcinoma of skin)
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis below Clavicle Clinical examination | Distant metastasis Clinical examination | Neoplasm Metastasis below Clavicle Radiography | Distant metastasis Radiography
Item
evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
boolean
C0027627 (UMLS CUI [1,1])
C0542339 (UMLS CUI [1,2])
C0008913 (UMLS CUI [1,3])
C1456356 (UMLS CUI [1,4])
C1269798 (UMLS CUI [2,1])
C1456356 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0542339 (UMLS CUI [3,2])
C0008913 (UMLS CUI [3,3])
C0043299 (UMLS CUI [3,4])
C1269798 (UMLS CUI [4,1])
C0043299 (UMLS CUI [4,2])
Radiation therapy to the head and neck Reason Any
Item
prior radiotherapy to the head and neck region for any reason.
boolean
C4540910 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Operative Surgical Procedures Initial | Exception Biopsy Primary tumor site | Exception Biopsy Disorder of neck
Item
initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
boolean
C0543467 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0475447 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0005558 (UMLS CUI [3,2])
C0558385 (UMLS CUI [3,3])
Primary tumor | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin.
boolean
C0677930 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
Pregnancy
Item
pregnant women
boolean
C0032961 (UMLS CUI [1])
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