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42004
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
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Versions (5)
- 12/26/17 12/26/17 -
- 12/27/17 12/27/17 -
- 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
- 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
- 9/20/21 9/20/21 -
Copyright Holder
Universität zu Köln
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March 15, 2021
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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
Registration
- 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
Similar models
Registration
- 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
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Date of birth
Item
Geburtsdatum
date
C0421451 (UMLS CUI [1])
CL Item
männlich (1)
C1305853 (UMLS CUI-1)
(Comment:de)
(Comment:de)
CL Item
weiblich (2)
C0015780 (UMLS CUI-1)
(Comment:de)
(Comment:de)
Study registration date
Item
Datum der Registrierung in Metro-NB 2012
date
C2985881 (UMLS CUI [1])
Study center
Item
Studienzentrumnummer
integer
C2826692 (UMLS CUI [1])
Study number
Item
Studiennr (Metro-NB 2012)
integer
C2826693 (UMLS CUI [1])
MARVIN ID
Item
MARVIN ID
integer
C0086373 (UMLS CUI [1])
GPOH-PID
Item
GPOH-PID
integer
C1549740 (UMLS CUI [1])
MaligID
Item
MaligID DKKR
integer
C1549740 (UMLS CUI [1])
Newly diagnosed recurrence or progression of high risk neuroblastoma
Item
Rezidiv oder Progression eines Hochrisikoneuroblastoms (nach INSS und GPOH-Kriterien) unabhängig von der Anzahl vorausgehender Rezidive/Progressionen?
boolean
C0027819 (UMLS CUI [1])
Age
Item
Alter: ≥ 2 Jahre und < 21 Jahre?
boolean
C0001779 (UMLS CUI [1])
Measurable or evaluable disease
Item
Messbare oder evaluierbare Erkrankung definiert wie folgt: Vorhandensein eines messbaren Tumorherdes (≥ 10mm in MRT/CT) und/oder eindeutige neue osteomedulläre Herde im mIBG-Szintigramm
boolean
C1513041 (UMLS CUI [1])
Minimal interval between start of trial medication and preceding anti-cancer treatment
Item
Zeitliches Mindestintervall zwischen Behandlungsbeginn und vorangehender Chemotherapie 4 Wochen, Radiotherapie 6 Wochen, myeloablativer Therapie 12 Wochen
boolean
C1272706 (UMLS CUI [1])
Life expectancy
Item
Lebenserwartung > 3 Monate
boolean
C0023671 (UMLS CUI [1])
Good to moderate general condition
Item
Gutes/mäßiges Gesamtbefinden (Lansky/Karnowski Index ≥ 60)
boolean
C1142435 (UMLS CUI [1])
No serious infection
Item
Keine schwere Infektion?
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,2])
Spontaneous recovering blood counts
Item
Blutbild-Mindestanforderungen: Leukozyten ≥ 1000/μL, Neutrophile ≥ 500/μL, Thrombozyten ≥ 50 000/μL
boolean
C0005771 (UMLS CUI [1])
Follow-up period
Item
Physische und psychosoziale Vorraussetzungen für die Nachbeobachtungszeit sowie die Handhabung von Toxizitäten sind gegeben?
boolean
C1522577 (UMLS CUI [1])
Written informed consent
Item
Schriftliche Einverständniserklärung der Erziehungsberechtigten bzw. des Patienten?
boolean
C0021430 (UMLS CUI [1])
Minimal residual disease
Item
Minimale Resterkrankung ohne messbare Tumorherde?
boolean
C1511791 (UMLS CUI [1])
Patients unable to swallow trial medication
Item
Orale Medikamenteneinnahme nicht möglich?
boolean
C3839225 (UMLS CUI [1])
Concomitant anti-cancer treatment
Item
Zusätzliche andere tumorbehandelnde Therapien (Medikamente, Radiotherapie, Operationen)?
boolean
C2348568 (UMLS CUI [1])
Antihypertensive drugs
Item
Einnahme von Mitteln zur Hochdruckbehandlung?
boolean
C0003364 (UMLS CUI [1])
Hypersensitivity to medication
Item
Überempfindlichkeit auf die Studienmedikation?
boolean
C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Severe medical or psychosocial conditions preventing trial participate
Item
Schwerwiegende medizinische oder psychosoziale Gründe, die eine Studienteilnahme unmöglich machen?
boolean
C0009488 (UMLS CUI [1])
Peripheral neuropathy
Item
Bestehende Neuropathie peripherer Nerven und/oder Obstipation Grad 3 oder 4?
boolean
C0031117 (UMLS CUI [1])
Cardiac arrhythmias
Item
Herzrhythmusstörungen?
boolean
C0003811 (UMLS CUI [1])
Bronchial asthma
Item
Bestehendes, rezidivierendes, symptomatisches Asthma Bronchiale?
boolean
C0004096 (UMLS CUI [1])
Diabetes mellitus
Item
Bestehender Diabetes mellitus?
boolean
C0011849 (UMLS CUI [1])
Low blood pressure
Item
Niedriger Blutdruck (unterhalb altersentsprechender Normwerte)?
boolean
C0020649 (UMLS CUI [1])
History of gastrointestinal ulcer or perforation
Item
Vorausgegangenes Ulcus oder Perforation im Magen-Darm-Trakt?
boolean
C0030920 (UMLS CUI [1])
C0151664 (UMLS CUI [2])
C0151664 (UMLS CUI [2])
Known active hepatitis B virus (HBV), hepatitis C (HBC) virus or human immunodeficiency virus (HIV) infection
Item
Bekannte aktive Infektion mit Hepatitis B, Hepatitis C oder HIV?
boolean
C0019682 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0220847 (UMLS CUI [3])
C0019163 (UMLS CUI [2])
C0220847 (UMLS CUI [3])
Concomitant participation in other clinical trials
Item
Gleichzeitige Teilnahme an einer anderen klinischen Studie mit Studienmedikation oder konkurrierenden Eingriffen?
boolean
C2348568 (UMLS CUI [1])
Pregnancy, lactation
Item
Positiver Schwangerschaftstest oder Stillphase
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Sexually active patients not willing to use highly effective contraception
Item
Sexuell aktive Patienten (männlich und weiblich) im reproduktiven Alter, die Verhütungsmaßnahmen nach ICH M3 ablehnen?
boolean
C0700589 (UMLS CUI [1])
Informed Consent
Item
Einwilligung zur Freigabe von Restprobenmaterial vorliegend?
boolean
C0021430 (UMLS CUI [1])
Comments
Item
Bemerkung
text
C0947611 (UMLS CUI [1])
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])
No comments