ID

44154

Description

NCT02641314 Phase 2 Trial of Metronomic Treatment in Children and Adolescents With Recurrent or Progressive Neuroblastoma (NB). The study investigates the tolerance and the efficacy of a new combination of five drugs consisting of propranolol (antiangiogenetic, anti-neuroblastic), Celecoxib (modulating immune response, ant-neuroblastic), cyclophosphamide (antiangiogenetic, anti-neuroblastic), etoposide (antiangiogenetic, anti-neuroblastic), and vinblastin (antiangiogenetic, anti-neuroblastic). Vinblastin is scheduled every 14 days intravenously, all other drugs are applied daily throughout 365 days (except etoposide for 4x3 weeks). The efficacies of each of the drugs have been demonstrated in vitro and in vivo in animal studies. All drugs have been used in children for other conditions. From those experiences low toxicities and a favorable Quality of life are expected. Prof. Dr. Frank Berthold Abt. für Kinderonkologie und –hämatologie Zentrum für Kinder- und Jugendmedizin Universität zu Köln

Keywords

Versions (5)
  1. 12/26/17 12/26/17 -
  2. 12/27/17 12/27/17 -
  3. 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
  4. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  5. 9/20/21 9/20/21 -
Copyright Holder

Universität zu Köln

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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Metronomic Treatment in Children and Adolescents With Recurrent or Progressive High Risk Neuroblastoma (METRO-NB2012) NCT02641314

German

Study relevant visits

16 forms  
Übersicht Visite
Description

Übersicht Visite

Visite
Description

Visit

Data type

text

Alias
UMLS CUI [1]
C0545082
Datum der Visite
Description

Date of visit

Data type

date

Measurement units
  • mm/dd/yyyy
Alias
UMLS CUI [1]
C1320303
mm/dd/yyyy
Grund für Untersuchung
Description

Indication of examination

Data type

text

Alias
UMLS CUI [1,1]
C3489408
UMLS CUI [1,2]
C0392360
Beurteilung der Lebensqualität
Description

Beurteilung der Lebensqualität

Lebensqualitätbögen ausgehändigt?
Description

quality of life

Data type

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0034380
Aushändigungdatum
Description

Date

Data type

date

Measurement units
  • mm/dd/yyyy
Alias
UMLS CUI [1]
C0011008
mm/dd/yyyy
Surrogatmarker
Description

Surrogatmarker

Wurde lokal eine Immunphänotypisierung gemacht?
Description

undefined item

Data type

boolean

Alias
UMLS CUI [1]
C0079611
Datum der Blutentnahme
Description

Collection of blood specimen for laboratory procedure Date in time

Data type

date

Measurement units
  • mm/dd/yyyy
Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
mm/dd/yyyy
Wurde der Untersuchungsbericht an die Studienzentrale gesendet?
Description

Report sent?

Data type

boolean

Alias
UMLS CUI [1,1]
C1524049
UMLS CUI [1,2]
C0520510
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0205099
Wurde Serum für die Untersuchung der Biomarker entnommen?
Description

biomarker

Data type

boolean

Alias
UMLS CUI [1]
C0005516
Datum der Blutentnahme
Description

Date blood sample

Data type

date

Measurement units
  • mm/dd/yyyy
Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
mm/dd/yyyy
Wurde das Serum an die Studienzentrale versendet?
Description

Specimen sent

Data type

boolean

Alias
UMLS CUI [1,1]
C1524049
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205099
Wurde das Serum im Batch an die Studienzentrale versendet?
Description

Batch

Data type

boolean

Alias
UMLS CUI [1]
C3641829
Versanddatum (ggf. im Batch)
Description

Shipping date in time

Data type

date

Measurement units
  • mm/dd/yyyy
Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1524049
UMLS CUI [1,3]
C0011008
mm/dd/yyyy
Bemerkung
Description

Bemerkung

Bemerkung
Description

Comment

Data type

text

Date
Description

Date

Data type

date

Investigator name
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Investigator signature
Description

Investigator signature

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Study relevant visits

16 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Übersicht Visite
Item
Visite
text
C0545082 (UMLS CUI [1])
Visit
Code List
Visite
CL Item
Baseline (V0) (Baseline (V0))
CL Item
Nach 3 Monaten (Q1) (Nach 3 Monaten (Q1))
CL Item
Nach 6 Monaten (V1) (Nach 6 Monaten (V1))
CL Item
Nach 12 Monaten oder EOT (V2) (Nach 12 Monaten oder EOT (V2))
CL Item
3 Monate nach EOT (3 Monate nach EOT)
CL Item
Sonstiger Zeitpunkt (Sonstiger Zeitpunkt)
Date of visit
Item
Datum der Visite
date
C1320303 (UMLS CUI [1])
Indication of examination
Item
Grund für Untersuchung
text
C3489408 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item Group
Beurteilung der Lebensqualität
quality of life
Item
Lebensqualitätbögen ausgehändigt?
boolean
C0034394 (UMLS CUI [1,1])
C0034380 (UMLS CUI [1,2])
Date
Item
Aushändigungdatum
date
C0011008 (UMLS CUI [1])
Item Group
Surrogatmarker
undefined item
Item
Wurde lokal eine Immunphänotypisierung gemacht?
boolean
C0079611 (UMLS CUI [1])
Collection of blood specimen for laboratory procedure Date in time
Item
Datum der Blutentnahme
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Report sent?
Item
Wurde der Untersuchungsbericht an die Studienzentrale gesendet?
boolean
C1524049 (UMLS CUI [1,1])
C0520510 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0205099 (UMLS CUI [1,4])
biomarker
Item
Wurde Serum für die Untersuchung der Biomarker entnommen?
boolean
C0005516 (UMLS CUI [1])
Date blood sample
Item
Datum der Blutentnahme
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Specimen sent
Item
Wurde das Serum an die Studienzentrale versendet?
boolean
C1524049 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205099 (UMLS CUI [1,3])
Batch
Item
Wurde das Serum im Batch an die Studienzentrale versendet?
boolean
C3641829 (UMLS CUI [1])
Shipping date in time
Item
Versanddatum (ggf. im Batch)
date
C0370003 (UMLS CUI [1,1])
C1524049 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Bemerkung
Comment
Item
Bemerkung
text
Date
Item
Date
date
Investigator name
Item
Investigator name
text
C2826892 (UMLS CUI [1])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
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