ID

31686

Description

Study to Evaluate Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil in Concurrence With Intensity-modulated Radiotherapy for Local Recurrent Nasopharyngeal Carcinoma (NPC); ODM derived from: https://clinicaltrials.gov/show/NCT01326559 Collaborating Parties: The University of Hong Kong Sanofi Merck Sharp & Dohme Corp. Roche Pharma AG

Link

https://clinicaltrials.gov/show/NCT01326559

Keywords

Versions (2)
  1. 9/16/18 9/16/18 -
  2. 9/21/18 9/21/18 -
Copyright Holder

Hong Kong Nasopharyngeal Cancer Study Group Limited

Uploaded on

September 21, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Nasopharyngeal Carcinoma NCT01326559

English

Eligibility Nasopharyngeal Carcinoma NCT01326559

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
recurrent t3n0-n1m0 npc (by ajcc/uicc 6th edition) and at least 1 year from the end of last primary course of radiotherapy
Description

AJCC Stage and recent radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0441915
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0262926
age > 18 to < 70 years
Description

Age group

Data type

boolean

Alias
UMLS CUI [1]
C0001779
performance status: < 1 by ecog system (appendix i)
Description

ECOG Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow & renal function
Description

Bone marrow and renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232804
patients having bilirubin =< 1.5 x uln, asat & alst=< 1.5 x uln, serum creatinine=< 1.25 x uln and / or creatinine clearance >= 60ml/min
Description

Bilirubin, AST, ALT, Creatinine and/or Creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201976
UMLS CUI [5]
C0373595
patients having wbc >= 3x10e9/l, neutrophils 1.8x10e9/l, platelets >= 100 x10e9/l,hemoglobin >=10g/dl
Description

WBC, neutrophils, platelet count, hemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
signed written informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients must have at least one measurable lesion
Description

One measurable lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C1513040
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of investigational agent within the past 28 days
Description

Recent use of investigational agent

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0332185
pre-treatment with an anti-egfr drug
Description

Anti-egfr pre-treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1443775
UMLS CUI [1,2]
C1514463
UMLS CUI [2,1]
C4055105
UMLS CUI [2,2]
C1514463
severe cardiac disease such as heart failure, coronary artery disease or myocardial infarction within the last 12 months
Description

Svere cardiac disease, heart failure, CAD or recent myocardial infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0018801
UMLS CUI [3]
C1956346
UMLS CUI [4,1]
C0027051
UMLS CUI [4,2]
C4086728
history of severe pulmonary diseases
Description

Respiratory comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0205082
active infection or other systemic disease under poor control
Description

Uncontrolled systemic disease or infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
uncontrolled chronic neuropathy
Description

Uncontrolled chronic neuropathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C0205318
know grade 3 or 4 allergic reaction to any of the components of the treatment
Description

Drug allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1875319
estimated life expectancy is less than 3 months
Description

Life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
pregnancy or breast feeding
Description

Pregnancy or breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Nasopharyngeal Carcinoma NCT01326559

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AJCC Stage and recent radiotherapy
Item
recurrent t3n0-n1m0 npc (by ajcc/uicc 6th edition) and at least 1 year from the end of last primary course of radiotherapy
boolean
C0441915 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
Age group
Item
age > 18 to < 70 years
boolean
C0001779 (UMLS CUI [1])
ECOG Status
Item
performance status: < 1 by ecog system (appendix i)
boolean
C1520224 (UMLS CUI [1])
Bone marrow and renal function
Item
adequate bone marrow & renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
Bilirubin, AST, ALT, Creatinine and/or Creatinine clearance
Item
patients having bilirubin =< 1.5 x uln, asat & alst=< 1.5 x uln, serum creatinine=< 1.25 x uln and / or creatinine clearance >= 60ml/min
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0373595 (UMLS CUI [5])
WBC, neutrophils, platelet count, hemoglobin
Item
patients having wbc >= 3x10e9/l, neutrophils 1.8x10e9/l, platelets >= 100 x10e9/l,hemoglobin >=10g/dl
boolean
C0023508 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Informed consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
One measurable lesion
Item
patients must have at least one measurable lesion
boolean
C0237753 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1513040 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Recent use of investigational agent
Item
use of investigational agent within the past 28 days
boolean
C0013230 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Anti-egfr pre-treatment
Item
pre-treatment with an anti-egfr drug
boolean
C1443775 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C4055105 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
Svere cardiac disease, heart failure, CAD or recent myocardial infarction
Item
severe cardiac disease such as heart failure, coronary artery disease or myocardial infarction within the last 12 months
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2])
C1956346 (UMLS CUI [3])
C0027051 (UMLS CUI [4,1])
C4086728 (UMLS CUI [4,2])
Respiratory comorbidity
Item
history of severe pulmonary diseases
boolean
C0024115 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Uncontrolled systemic disease or infection
Item
active infection or other systemic disease under poor control
boolean
C0442893 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Uncontrolled chronic neuropathy
Item
uncontrolled chronic neuropathy
boolean
C0442874 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Drug allergy
Item
know grade 3 or 4 allergic reaction to any of the components of the treatment
boolean
C0013182 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1875319 (UMLS CUI [1,3])
Life expectancy
Item
estimated life expectancy is less than 3 months
boolean
C0023671 (UMLS CUI [1])
Pregnancy or breast feeding
Item
pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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