ID

13342

Description

PHASE III TRIAL COMPARING, NEOADJUVANT CHEMOTHERAPY FOLLOWED BY STANDARD RADIOTHERAPY VERSUS THE SAME NEOADJUVANT CHEMOTHERAPY FOLLOWED BY STANDARD RADIOTHERAPY ASSOCIATED WITH DAILY HYDROXYUREA IN THE TREATMENT OF LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE.; ODM derived from: https://clinicaltrials.gov/show/NCT00180973

Link

https://clinicaltrials.gov/show/NCT00180973

Keywords

Versions (1)
  1. 2/7/16 2/7/16 -
Uploaded on

February 7, 2016

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License

Creative Commons BY 4.0
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Eligibility LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE UCNT NCT00180973

English

Eligibility LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE UCNT NCT00180973

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
of either sex
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
aged 15 to 70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
never previously treated with radiotherapy, chemotherapy or surgery for malignant disease (except neck adenectomy/diagnosis)
Description

ID.3

Data type

boolean

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0038894
with awho performance status * 2.
Description

who performance

Data type

boolean

Alias
UMLS CUI [1]
C1298650
amenable to regular follow-up
Description

follow-up

Data type

boolean

Alias
UMLS CUI [1]
C1321605
capable of receiving chemotherapy and radiotherapy : in particular, with no contraindications to the use of anthracyclines, bleomycin or cisplatinum.
Description

capable of receiving therapy

Data type

boolean

Alias
UMLS CUI [1]
C1321605
with informed consent at entry time, in writing or witnessed oral informed consent, in accordance with local legislation requirements.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
neutrophil count * 2000 /mm3 platelet count * 150,000 /mm3 hemoglobin * 10 g / dl
Description

Laboratory results

Data type

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0005821
UMLS CUI [3]
C0019046
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
histologic types other than type ii - iii of the who classification
Description

histology

Data type

boolean

Alias
UMLS CUI [1]
C0449574
t1 - t2 n0 - n1 or patients with metastatic
Description

Tumor stage

Data type

boolean

Alias
UMLS CUI [1]
C1300072
aged < 15 or > 70.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients in whom chemotherapy is contraindicated: history of myocardial infarction over the last 6 months before inclusion, or clinically present cardiac pathology.
Description

contraindication chemotherapy, myocardial infarcion, heart diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0392920
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0018799
who performance status >2
Description

who performance

Data type

boolean

Alias
UMLS CUI [1]
C1298650
history of prior malignancies (other than non melanoma skin cancer or excised cervical carcinoma in situ).
Description

prior malignancies

Data type

boolean

Alias
UMLS CUI [1]
C0006826
uncontrolled infection,
Description

uncontrolled infection

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patients refusing participation.
Description

refusing participation

Data type

boolean

Alias
UMLS CUI [1]
C1321605
patients who, for social, familial or geographic reasons are unlikely to comply with a long term follow-up.
Description

unlikely to comply with a long term follow-up

Data type

boolean

Alias
UMLS CUI [1]
C1321605
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Similar models

Eligibility LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE UCNT NCT00180973

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
of either sex
boolean
C0079399 (UMLS CUI [1])
Age
Item
aged 15 to 70 years
boolean
C0001779 (UMLS CUI [1])
ID.3
Item
never previously treated with radiotherapy, chemotherapy or surgery for malignant disease (except neck adenectomy/diagnosis)
boolean
C0087111 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0038894 (UMLS CUI [4])
who performance
Item
with awho performance status * 2.
boolean
C1298650 (UMLS CUI [1])
follow-up
Item
amenable to regular follow-up
boolean
C1321605 (UMLS CUI [1])
capable of receiving therapy
Item
capable of receiving chemotherapy and radiotherapy : in particular, with no contraindications to the use of anthracyclines, bleomycin or cisplatinum.
boolean
C1321605 (UMLS CUI [1])
informed consent
Item
with informed consent at entry time, in writing or witnessed oral informed consent, in accordance with local legislation requirements.
boolean
C0021430 (UMLS CUI [1])
Laboratory results
Item
neutrophil count * 2000 /mm3 platelet count * 150,000 /mm3 hemoglobin * 10 g / dl
boolean
C0200633 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
histology
Item
histologic types other than type ii - iii of the who classification
boolean
C0449574 (UMLS CUI [1])
Tumor stage
Item
t1 - t2 n0 - n1 or patients with metastatic
boolean
C1300072 (UMLS CUI [1])
Age
Item
aged < 15 or > 70.
boolean
C0001779 (UMLS CUI [1])
contraindication chemotherapy, myocardial infarcion, heart diseases
Item
patients in whom chemotherapy is contraindicated: history of myocardial infarction over the last 6 months before inclusion, or clinically present cardiac pathology.
boolean
C1301624 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
who performance
Item
who performance status >2
boolean
C1298650 (UMLS CUI [1])
prior malignancies
Item
history of prior malignancies (other than non melanoma skin cancer or excised cervical carcinoma in situ).
boolean
C0006826 (UMLS CUI [1])
uncontrolled infection
Item
uncontrolled infection,
boolean
C0009488 (UMLS CUI [1])
refusing participation
Item
patients refusing participation.
boolean
C1321605 (UMLS CUI [1])
unlikely to comply with a long term follow-up
Item
patients who, for social, familial or geographic reasons are unlikely to comply with a long term follow-up.
boolean
C1321605 (UMLS CUI [1])
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