ID

31738

Beschreibung

Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma (NPC); ODM derived from: https://clinicaltrials.gov/show/NCT00817583

Link

https://clinicaltrials.gov/show/NCT00817583

Stichworte

Versionen (1)
  1. 24.09.18 24.09.18 -
Rechteinhaber

Fudan University

Hochgeladen am

24. September 2018

DOI

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Creative Commons BY-NC 3.0
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Eligibility Nasopharyngeal Carcinoma NCT00817583

Englisch

Eligibility Nasopharyngeal Carcinoma NCT00817583

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
-histopathologically proved who type ii and type iii carcinoma of the nasopharynx.
Beschreibung

Histologically proved Nasopharynx-Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301142
UMLS CUI [1,2]
C2931822
stage ⅲ, iva and ivb disease
Beschreibung

disease stage

Datentyp

boolean

Alias
UMLS CUI [1]
C0699749
kps >70
Beschreibung

Karnofsky Performance Status

Datentyp

boolean

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

Age

Datentyp

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.
Beschreibung

Granulocyte count, Platelet count, bilirubin, creatinin (serum), creatinin-clearance

Datentyp

boolean

Alias
UMLS CUI [1]
C0857490
UMLS CUI [2,1]
C0005821
UMLS CUI [2,2]
C3539076
UMLS CUI [3]
C0201913
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201976
UMLS CUI [7]
C0373595
the primary tumor or involved lymph node must be more than 2cm in diameter.
Beschreibung

Tumor size | Size of lymph node

Datentyp

boolean

Alias
UMLS CUI [1]
C0475440
UMLS CUI [2]
C1285847
no prior radiation treatment to the head and neck or any prior chemotherapy
Beschreibung

No prior radiation therapy of head and neck, no prior chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0460004
UMLS CUI [1,4]
C0332152
UMLS CUI [2,1]
C1298908
UMLS CUI [2,2]
C1514457
patients with no prior malignancy (not include basal cell carcinoma of skin)
Beschreibung

No prior malignancy, basal cell carcinoma excepted

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Metastasis (below the clavicle or distant)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1302548
UMLS CUI [1,2]
C0031809
UMLS CUI [2,1]
C1302548
UMLS CUI [2,2]
C0043299
UMLS CUI [3,1]
C0229743
UMLS CUI [3,2]
C0027627
UMLS CUI [3,3]
C0031809
UMLS CUI [4,1]
C0229743
UMLS CUI [4,2]
C0027627
UMLS CUI [4,3]
C0043299
prior radiotherapy to the head and neck region for any reason.
Beschreibung

Prior radiation therapy of head and neck

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0460004
initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
Beschreibung

Surgical treatment excluding diagnostic biopsy of the primary site or neck disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0005558
UMLS CUI [1,4]
C1402294
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0005558
UMLS CUI [2,4]
C0027530
UMLS CUI [2,5]
C0012634
patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin.
Beschreibung

Previous/simultaneous primaries (excluding basal cell carcinoma/squamous cell carcinoma)

Datentyp

boolean

Alias
UMLS CUI [1]
C2735087
UMLS CUI [2]
C0027663
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
pregnant women
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
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Ähnliche Modelle

Eligibility Nasopharyngeal Carcinoma NCT00817583

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Histologically proved Nasopharynx-Carcinoma
Item
-histopathologically proved who type ii and type iii carcinoma of the nasopharynx.
boolean
C1301142 (UMLS CUI [1,1])
C2931822 (UMLS CUI [1,2])
disease stage
Item
stage ⅲ, iva and ivb disease
boolean
C0699749 (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])
Granulocyte count, Platelet count, bilirubin, creatinin (serum), creatinin-clearance
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
C0857490 (UMLS CUI [1])
C0005821 (UMLS CUI [2,1])
C3539076 (UMLS CUI [2,2])
C0201913 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C0373595 (UMLS CUI [7])
Tumor size | Size of lymph node
Item
the primary tumor or involved lymph node must be more than 2cm in diameter.
boolean
C0475440 (UMLS CUI [1])
C1285847 (UMLS CUI [2])
No prior radiation therapy of head and neck, no prior chemotherapy
Item
no prior radiation treatment to the head and neck or any prior chemotherapy
boolean
C1298908 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0460004 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C1298908 (UMLS CUI [2,1])
C1514457 (UMLS CUI [2,2])
No prior malignancy, basal cell carcinoma excepted
Item
patients with no prior malignancy (not include basal cell carcinoma of skin)
boolean
C1298908 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Metastasis (below the clavicle or distant)
Item
evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
boolean
C1302548 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C1302548 (UMLS CUI [2,1])
C0043299 (UMLS CUI [2,2])
C0229743 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C0031809 (UMLS CUI [3,3])
C0229743 (UMLS CUI [4,1])
C0027627 (UMLS CUI [4,2])
C0043299 (UMLS CUI [4,3])
Prior radiation therapy of head and neck
Item
prior radiotherapy to the head and neck region for any reason.
boolean
C1522449 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0460004 (UMLS CUI [1,3])
Surgical treatment excluding diagnostic biopsy of the primary site or neck disease
Item
initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
boolean
C0543467 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
C1402294 (UMLS CUI [1,4])
C0543467 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0005558 (UMLS CUI [2,3])
C0027530 (UMLS CUI [2,4])
C0012634 (UMLS CUI [2,5])
Previous/simultaneous primaries (excluding basal cell carcinoma/squamous cell carcinoma)
Item
patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin.
boolean
C2735087 (UMLS CUI [1])
C0027663 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
Pregnancy
Item
pregnant women
boolean
C0032961 (UMLS CUI [1])
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