ID

44154

Beschrijving

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

Trefwoorden

Versies (5)
  1. 26-12-17 26-12-17 -
  2. 27-12-17 27-12-17 -
  3. 15-03-21 15-03-21 - Dr. rer. medic Philipp Neuhaus
  4. 13-04-21 13-04-21 - Dr. rer. medic Philipp Neuhaus
  5. 20-09-21 20-09-21 -
Houder van rechten

Universität zu Köln

Geüploaded op

20 september 2021

DOI

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Licentie

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

Duits

Follow up

16 Formulieren  
Bewertung des Patienten
Beschrijving

Bewertung des Patienten

Datum
Beschrijving

Die Dokumentation des Follow-Up erfolgt mindestens bis zur Sperrung der Datenbank zur Durchgeführung der finalen Analyse. Follow-Up Untersuchungen sollten alle 3-6 Monate durchgeführt werden.

Datatype

date

Maateenheden
  • mm/dd/yyyy
Alias
UMLS CUI [1]
C0011008
mm/dd/yyyy
Allgemeinzustand nach Lansky (≤ 16 Jahre) oder Karnofsky Skala*
Beschrijving

Karnofsky Performance Status

Datatype

integer

Alias
UMLS CUI [1]
C0206065
Remissionsstatus
Beschrijving

Disease remission; Status

Datatype

integer

Alias
UMLS CUI [1,1]
C0544452
UMLS CUI [1,2]
C0449438
Wenn verstorben: Todesdatum
Beschrijving

Date of death

Datatype

date

Maateenheden
  • mm/dd/yyyy
Alias
UMLS CUI [1]
C1148348
mm/dd/yyyy
Rezidiv oder Progression
Beschrijving

Relpase

Datatype

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C0035020
Ort des Rezidivs/Progression
Beschrijving

Date in time; Recurrent disease

Datatype

text

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0277556
Bemerkung
Beschrijving

Comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
Footer module
Beschrijving

Footer module

Date
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
Investigator name
Beschrijving

Investigator name

Datatype

text

Alias
UMLS CUI [1]
C2826892
Investigator signature
Beschrijving

Investigator signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Follow up

16 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Bewertung des Patienten
Date
Item
Datum
date
C0011008 (UMLS CUI [1])
Karnofsky Performance Status
Item
Allgemeinzustand nach Lansky (≤ 16 Jahre) oder Karnofsky Skala*
integer
C0206065 (UMLS CUI [1])
Item
Remissionsstatus
integer
C0544452 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Disease remission; Status
Code List
Remissionsstatus
CL Item
Nicht auswertbar (6)
C1883425 (UMLS CUI-1)
(Comment:de)
CL Item
Komplette Remission (CR)
C0677874 (UMLS CUI-1)
(Comment:de)
CL Item
Sehr gute partielle Remission (VGPR )
C4053871 (UMLS CUI-1)
(Comment:de)
CL Item
Partielle Remission (PR)
C1275833 (UMLS CUI-1)
(Comment:de)
CL Item
Unverändert (SD)
C0677946 (UMLS CUI-1)
(Comment:de)
CL Item
Progression (PD)
C0242656 (UMLS CUI-1)
(Comment:de)
Date of death
Item
Wenn verstorben: Todesdatum
date
C1148348 (UMLS CUI [1])
Relpase
Item
Rezidiv oder Progression
boolean
C0277556 (UMLS CUI [1])
C0035020 (UMLS CUI [2])
Date in time; Recurrent disease
Item
Ort des Rezidivs/Progression
text
C0011008 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
Comment
Item
Bemerkung
text
C0947611 (UMLS CUI [1])
Item Group
Footer module
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Investigator name
Item
Investigator name
text
C2826892 (UMLS CUI [1])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
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