ID
28181
Beschreibung
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
Stichworte
Versionen (5)
- 26.12.17 26.12.17 -
- 27.12.17 27.12.17 -
- 15.03.21 15.03.21 - Dr. rer. medic Philipp Neuhaus
- 13.04.21 13.04.21 - Dr. rer. medic Philipp Neuhaus
- 20.09.21 20.09.21 -
Rechteinhaber
Universität zu Köln
Hochgeladen am
27. Dezember 2017
DOI
10.21961/mdm:28181
Lizenz
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
Baseline
- StudyEvent: Subject Protocol
- Registration
- Medical history
- Baseline
- Therapy and toxicity cycle 1-3
- Therapy and toxicity cycle 4-6
- Therapy and toxicity cycle 7-9
- Therapy and toxicity cycle 10-13
- Therapy and toxicity cycle > 13
- Reference
- Study relevant visits
- Therapeutic response
- End of therapy
- Relapse
- Second malignancy
- Death
- Follow up
Beschreibung
Kardiologische Untersuchungen
Alias
- UMLS CUI-1
- C0007189
- UMLS CUI-2
- C0031809
Beschreibung
Date of Echocardiography
Datentyp
date
Maßeinheiten
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0013516
Beschreibung
Cardiac ejection fraction
Datentyp
integer
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0232174
Beschreibung
Electrocardiography date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0011008
Beschreibung
ECG finding
Datentyp
integer
Alias
- UMLS CUI [1]
- C0438154
Beschreibung
ECG abnormal reason
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0362082
Beschreibung
Findings sent to patient?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519246
- UMLS CUI [1,2]
- C1519246
Beschreibung
Laboruntersuchungen
Beschreibung
White Blood Cell Count
Datentyp
integer
Maßeinheiten
- Mikroliter
Alias
- UMLS CUI [1]
- C0023508
Beschreibung
Absolute neutrophil count
Datentyp
integer
Maßeinheiten
- yL
Alias
- UMLS CUI [1]
- C0948762
Beschreibung
Hemoglobin
Datentyp
integer
Maßeinheiten
- g/dl
Alias
- UMLS CUI [1]
- C0019046
Beschreibung
Blood Platelets
Datentyp
integer
Maßeinheiten
- yL
Alias
- UMLS CUI [1]
- C0005821
Beschreibung
Glucose measurement
Datentyp
integer
Alias
- UMLS CUI [1]
- C0337438
Beschreibung
Tumormarker
Beschreibung
NSE
Datentyp
integer
Maßeinheiten
- μg/l
Alias
- UMLS CUI [1]
- C0202144
Beschreibung
NSE result
Datentyp
integer
Alias
- UMLS CUI [1]
- C0202144
Beschreibung
LDH
Datentyp
integer
Maßeinheiten
- U/l
Alias
- UMLS CUI [1]
- C0202113
Beschreibung
LDH result
Datentyp
integer
Alias
- UMLS CUI [1]
- C0202113
Beschreibung
Urine VMA level result
Datentyp
integer
Maßeinheiten
- mg/g Crea
Alias
- UMLS CUI [1]
- C1261438
Beschreibung
Unit vma
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1261438
- UMLS CUI [1,2]
- C1519795
Beschreibung
age dependent vma factor
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1835978
- UMLS CUI [1,2]
- C0042317
- UMLS CUI [1,3]
- C1521761
Beschreibung
vma result
Datentyp
integer
Alias
- UMLS CUI [1]
- C1261438
Beschreibung
homovanillic acid
Datentyp
integer
Maßeinheiten
- mg/g Crea
Alias
- UMLS CUI [1]
- C0202071
Beschreibung
homovanillic acid unit
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0202071
- UMLS CUI [1,2]
- C0439148
Beschreibung
age dependent factor
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1835978
- UMLS CUI [1,2]
- C1521761
- UMLS CUI [1,3]
- C0202071
Beschreibung
Homovanillic acid measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C0202071
Beschreibung
Surrogatmarker
Beschreibung
Immunophenotyping
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0079611
Beschreibung
Collection of blood specimen for laboratory procedure date in time
Datentyp
date
Maßeinheiten
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Beschreibung
Shipping
Datentyp
date
Maßeinheiten
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C1524049
- UMLS CUI [1,3]
- C0011008
Beschreibung
Lebensqualität
Beschreibung
Bildgebung
Alias
- UMLS CUI-1
- C0011923
Beschreibung
MRT / CT
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0024485
- UMLS CUI [2]
- C0040405
Beschreibung
mIBG
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0047506
Beschreibung
Bone Marrow Examination
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0005957
Beschreibung
Other examination?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0086141
- UMLS CUI [1,2]
- C0205394
Beschreibung
Specify other examination
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0086141
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Beschreibung
Lokale MRT/CT Beurteilung
Beschreibung
MRT Untersuchungen werden bevorzugt
Datentyp
date
Maßeinheiten
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C2985720
- UMLS CUI [1,2]
- C0024485
Beschreibung
Evaluation method
Datentyp
integer
Alias
- UMLS CUI [1]
- C2911685
Beschreibung
Anatomic site
Datentyp
integer
Alias
- UMLS CUI [1]
- C1515974
Beschreibung
Primary tumor
Datentyp
integer
Alias
- UMLS CUI [1]
- C0677930
Beschreibung
Status of distant metastasis
Datentyp
integer
Alias
- UMLS CUI [1]
- C1302548
Beschreibung
Osteomedullärer Befall hier definiert als zytologischer Knochenmark-Befall und/oder szintigraphischer Nachweis und/oder radiologischer Nachweis (Röntgen oder CT). Nicht-Kontrastmittel aufnehmende Knochenmark-Veränderungen allein im MRT Kernspintomographien werden nicht als osteomedullärer Befall gewertet.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0153690
- UMLS CUI [2]
- C0346979
Beschreibung
Cave: lokoregionäre Lymphknoten-Metastasen in derselben Höhe des Primärtumors werden nicht als Lymphknotenfernmetastasen gewertet.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3830456
- UMLS CUI [1,2]
- C2939420
- UMLS CUI [1,3]
- C0024485
Beschreibung
Secondary malignant neoplasm of liver
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0494165
- UMLS CUI [1,2]
- C0024485
Beschreibung
Secondary malignant neoplasm of skin
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0153687
- UMLS CUI [1,2]
- C0024485
Beschreibung
ZNS-Metastasen sind definiert als intrazerebrale Parenchym-Herde, rein intraspinale Parenchym-Herde oder diffuse leptomeningeale Metastasen. Nicht als ZNS-Befall gewertet wird eine regionale Mitbeteiligung der Dura bei osteomedullärer Metastasierung des angrenzenden Knochens.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0686377
Beschreibung
Neoplasm Metastasis; Other
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0027627
- UMLS CUI [1,2]
- C0205394
Beschreibung
Specify other neoplasm metastasis
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0027627
- UMLS CUI [1,3]
- C0205394
Beschreibung
Lokale MRT/CT Beurteilung
Beschreibung
Lokale mIBG-Beurteilung
Alias
- UMLS CUI-1
- C2229074
Beschreibung
MIBG scintiscan date
Datentyp
date
Maßeinheiten
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C2229074
- UMLS CUI [1,2]
- C0011008
Beschreibung
MIBG Finding primary tumor
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2229074
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0677930
Beschreibung
mIBG findings metastasis
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2229074
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C4255448
Beschreibung
MIBG scintiscan findings sent
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2229074
- UMLS CUI [1,2]
- C1519246
- UMLS CUI [1,3]
- C0220825
Beschreibung
Knochenmarkuntersuchungen
Alias
- UMLS CUI-1
- C0005957
Beschreibung
Method Bone Marrow Examination
Datentyp
integer
Alias
- UMLS CUI [1]
- C0005957
Beschreibung
Bone marrow biopsy date
Datentyp
date
Maßeinheiten
- mm/dd/yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005954
Beschreibung
Bone marrow sent?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1514873
- UMLS CUI [1,2]
- C0520510
- UMLS CUI [1,3]
- C1524049
- UMLS CUI [1,4]
- C0005953
- UMLS CUI [1,5]
- C0005767
Beschreibung
Sonstige Untersuchungen
Alias
- UMLS CUI-1
- C0260879
Beschreibung
Examination date
Datentyp
date
Maßeinheiten
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C2826643
Beschreibung
Specimen sent?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519246
Beschreibung
Examination method specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1282548
- UMLS CUI [1,2]
- C1521902
Beschreibung
Finding primary tumor
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0243095
- UMLS CUI [1,2]
- C0677930
Beschreibung
Findings bone metastases
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0153690
- UMLS CUI [1,2]
- C0243095
Beschreibung
Finding distant lymph node
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0243095
- UMLS CUI [1,2]
- C3830456
Beschreibung
Liver finding
Datentyp
integer
Alias
- UMLS CUI [1]
- C0426686
Beschreibung
Skin finding
Datentyp
integer
Alias
- UMLS CUI [1]
- C0455205
Beschreibung
Finding CNS
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3714787
- UMLS CUI [1,2]
- C0243095
Beschreibung
Finding other metastases
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0027627
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1335151
Beschreibung
Other Metastasis specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0027627
- UMLS CUI [1,3]
- C0205394
Beschreibung
Gesamtbeurteilung
Beschreibung
CR: Kein Primärtumor und keine Metastasen nachweisbar, Katecholamine normal VGPR: Primärtumor-Reduktion um 90-99%. Keine Metastasen nachweisbar, Katecholamine normal, Nachweis von Resten bei Knochenszintigrafie erlaubt PR: Primärtumor-Reduktion um >50%, Alle messbaren Metastasen haben sich um >50% reduziert. Knochen und KM: Knochenbefall hat sich um >50% reduziert; nicht mehr als 1 positiver KM-Befund erlaubt (muss einer Abnahme in der Anzahl an positiven Befunden im Vergleich zur Diagnose entsprechen) SD: Keine neuen Läsionen nachweisbar; PD: Nachweis einer neuen Läsionen und/oder Zunahme einer messbaren Läsionen um >25%; vorangegangenes negatives Knochenmark wird Tumor-positiv
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0544452
- UMLS CUI [1,2]
- C0449438
- UMLS CUI [1,3]
- C0432510
Beschreibung
Date
Datentyp
date
Maßeinheiten
- mm/dd/yyyy
Alias
- UMLS CUI [1]
- C0011008
Beschreibung
Investigator name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Investigator signature
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Ähnliche Modelle
Baseline
- StudyEvent: Subject Protocol
- Registration
- Medical history
- Baseline
- Therapy and toxicity cycle 1-3
- Therapy and toxicity cycle 4-6
- Therapy and toxicity cycle 7-9
- Therapy and toxicity cycle 10-13
- Therapy and toxicity cycle > 13
- Reference
- Study relevant visits
- Therapeutic response
- End of therapy
- Relapse
- Second malignancy
- Death
- Follow up
C0206065 (UMLS CUI [2])
C0031809 (UMLS CUI [1,2])
C0031809 (UMLS CUI-2)
C0013516 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
(Comment:de)
(Comment:de)
C0362082 (UMLS CUI [1,2])
C1519246 (UMLS CUI [1,2])
(Comment:de)
(Comment:de)
C0205307 (UMLS CUI-2)
(Comment:de)
C0205161 (UMLS CUI-2)
(Comment:de)
(Comment:de)
(Comment:de)
C1519795 (UMLS CUI [1,2])
C0042317 (UMLS CUI [1,2])
C1521761 (UMLS CUI [1,3])
(Comment:de)
C0205161 (UMLS CUI-2)
(Comment:de)
C0439148 (UMLS CUI [1,2])
C1521761 (UMLS CUI [1,2])
C0202071 (UMLS CUI [1,3])
C0086715 (UMLS CUI-2)
(Comment:de)
C0205161 (UMLS CUI-2)
(Comment:de)
C0011008 (UMLS CUI [1,2])
C1524049 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0034380 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040405 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0024485 (UMLS CUI [1,2])
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
C1275402 (UMLS CUI-2)
(Comment:de)
C0346979 (UMLS CUI [2])
C2939420 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C0024485 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,3])
(Comment:de)
(Comment:de)
C0243095 (UMLS CUI [1,2])
C4255448 (UMLS CUI [1,3])
(Comment:de)
C0205161 (UMLS CUI-3)
(Comment:de)
C0027627 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
(Comment:de)
C0153690 (UMLS CUI-3)
C0027627 (UMLS CUI-4)
C0205394 (UMLS CUI-5)
(Comment:de)
C1519246 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
(Comment:de)
(Comment:de)
|C0349707 (UMLS CUI-2)
(Comment:de)
(Comment:de)
C0005954 (UMLS CUI [1,2])
C0520510 (UMLS CUI [1,2])
C1524049 (UMLS CUI [1,3])
C0005953 (UMLS CUI [1,4])
C0005767 (UMLS CUI [1,5])
C1521902 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,2])
(Comment:de)
(Comment:de)
C0243095 (UMLS CUI [1,2])
(Comment:de)
(Comment:de)
C3830456 (UMLS CUI [1,2])
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
C0205394 (UMLS CUI [1,2])
C1335151 (UMLS CUI [1,3])
C0027627 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0449438 (UMLS CUI [1,2])
C0432510 (UMLS CUI [1,3])
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)
(Comment:de)