ID
32434
Beschreibung
HD16 NCT Nr.: NCT00736320 HD16 for Early Stages - Treatment Optimization Trial in the First-line Treatment of Early Stage Hodgkin Lymphoma; Treatment Stratification by Means of FDG-PET. This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of Progression free survival (PFS). HD17 NCT Nr.: NCT01356680 HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma.This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of progression free survival (PFS). HD18 NCT Nr.: NCT00515554 HD18 for Advanced Stages in Hodgkins Lymphoma. This study is designed to test: in patients with negative positron-emission tomography (PET) after 2 cycles of BEACOPPesc chemotherapy: whether the number of cycles can be reduced without compromising progression free survival (PFS) (2 further cycles vs. 6 further cycles) for patients with positive PET after 2 cycles: whether intensifying BEACOPPesc chemotherapy by adding Rituximab improves PFS. Permission granted by: Andreas Engert, M.D. Chairman, German Hodgkin Study Group Professor for Internal Medicine Hematology & Oncology University Hospital of Cologne Department of Internal Medicine I Kerpener Str. 62 D-50924 Köln Phone: +49-221-478-5933/5966 Fax: +49-221-478-3778 a.engert@uni-koeln.de
Stichworte
Versionen (5)
- 25.04.17 25.04.17 -
- 25.04.17 25.04.17 -
- 03.05.17 03.05.17 -
- 19.05.17 19.05.17 -
- 01.11.18 01.11.18 - Sarah Riepenhausen
Rechteinhaber
German Hodgkin Study Group
Hochgeladen am
1. November 2018
DOI
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Lizenz
Creative Commons BY-NC 3.0
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German Hodgkin Study Group Study HD16/HD17/HD18 Chemotherapy regimen G6C DRKS00003455
Deutsche Hodgkin Studiengruppe: G6C Chemotherapiebogen
- StudyEvent: ODM
Beschreibung
Chemotherapiebogen
Alias
- UMLS CUI-1
- C0392920
Beschreibung
Nur vor Kurs 1: 4 Tage à 40mg
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0011777
- UMLS CUI [1,2]
- C1880049
Beschreibung
Cycle Number
Datentyp
integer
Alias
- UMLS CUI [1]
- C2045829
Beschreibung
Treatment start date
Datentyp
date
Alias
- UMLS CUI [1]
- C3173309
Beschreibung
Treatment End date
Datentyp
date
Alias
- UMLS CUI [1]
- C1531784
Beschreibung
375mg/m2 i.v im 4.Zyklus Tag 0+3; ab 5.Zyklus Tag 1
Datentyp
integer
Maßeinheiten
- mg
Alias
- UMLS CUI [1,1]
- C0393022
- UMLS CUI [1,2]
- C2986497
- UMLS CUI [1,3]
- C1302181
Beschreibung
1250mg/m2 i.v Tag 1
Datentyp
integer
Maßeinheiten
- mg
Alias
- UMLS CUI [1,1]
- C0010583
- UMLS CUI [1,2]
- C2986497
- UMLS CUI [1,3]
- C1302181
Beschreibung
35mg/m2 i.v Tag 1
Datentyp
integer
Maßeinheiten
- mg
Alias
- UMLS CUI [1,1]
- C0085752
- UMLS CUI [1,2]
- C2986497
- UMLS CUI [1,3]
- C1302181
Beschreibung
200mg/m2 i.v Tag 1-3
Datentyp
integer
Maßeinheiten
- mg
Alias
- UMLS CUI [1,1]
- C0904036
- UMLS CUI [1,2]
- C2986497
- UMLS CUI [1,3]
- C1302181
Beschreibung
100mg/m2 p.o Tag 1-7
Datentyp
integer
Maßeinheiten
- mg
Alias
- UMLS CUI [1,1]
- C0033223
- UMLS CUI [1,2]
- C2986497
- UMLS CUI [1,3]
- C1302181
Beschreibung
40mg/m2 p.o Tag 1-14
Datentyp
integer
Maßeinheiten
- mg
Alias
- UMLS CUI [1,1]
- C0032952
- UMLS CUI [1,2]
- C2986497
- UMLS CUI [1,3]
- C1302181
Beschreibung
1,4mg/m2 i.v (max. 2mg) Tag 8
Datentyp
integer
Maßeinheiten
- mg
Alias
- UMLS CUI [1,1]
- C0042679
- UMLS CUI [1,2]
- C2986497
- UMLS CUI [1,3]
- C1302181
Beschreibung
10mg/m2 i.v Tag 8
Datentyp
integer
Maßeinheiten
- mg
Alias
- UMLS CUI [1,1]
- C1589326
- UMLS CUI [1,2]
- C2986497
- UMLS CUI [1,3]
- C1302181
Beschreibung
GCSF
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0376562
Beschreibung
GCSF number of days
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0376562
- UMLS CUI [1,2]
- C0556971
Beschreibung
Neupogen
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0733468
Beschreibung
Neulasta
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1171279
Beschreibung
Granocyte
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0218640
Beschreibung
Other GCSF
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0079459
- UMLS CUI [1,2]
- C0205394
Beschreibung
Erythropoetin
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0014822
Beschreibung
Erythropoetin, Count of Doses
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0014822
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0750480
Beschreibung
Platelet Concentrate
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1293886
Beschreibung
Count of Platelet Concentrates
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1293886
- UMLS CUI [1,2]
- C0449788
Beschreibung
Red blood cell concentrate
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0086252
Beschreibung
Count of Red blood cell concentrates
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0086252
- UMLS CUI [1,2]
- C0449788
Beschreibung
Febrile Neutropenia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0746883
Beschreibung
Days of inpatient care because of febrile neutropenia
Datentyp
integer
Maßeinheiten
- Tage
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C0019993
- UMLS CUI [1,3]
- C0746883
Beschreibung
Leukopenia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0023530
Beschreibung
Days of Leukopenia
Datentyp
integer
Maßeinheiten
- Tage
Alias
- UMLS CUI [1,1]
- C0023530
- UMLS CUI [1,2]
- C0449238
Beschreibung
Days with fever equal or higher 38°C
Datentyp
integer
Maßeinheiten
- Tage
Alias
- UMLS CUI [1,1]
- C1959900
- UMLS CUI [1,2]
- C0449238
Beschreibung
Labor vor Therapiebeginn
Alias
- UMLS CUI-1
- C0022877
- UMLS CUI-2
- C0332152
- UMLS CUI-3
- C3173309
Beschreibung
Chemotherapy cycle
Datentyp
integer
Alias
- UMLS CUI [1]
- C2045829
Beschreibung
Hemoglobin
Datentyp
float
Maßeinheiten
- g/dL
Alias
- UMLS CUI [1]
- C0019046
Beschreibung
Hemoglobin
Datentyp
float
Maßeinheiten
- mmol/l
Alias
- UMLS CUI [1]
- C0019046
Beschreibung
WBC
Datentyp
float
Maßeinheiten
- x10^3/µl
Alias
- UMLS CUI [1]
- C0023508
Beschreibung
Platelets
Datentyp
integer
Maßeinheiten
- x10^3/µl
Alias
- UMLS CUI [1]
- C0005821
Beschreibung
Toxizitäten
Beschreibung
Cycle number
Datentyp
integer
Alias
- UMLS CUI [1]
- C2045829
Beschreibung
Bei Toxizitäten CTC Grad 3/4 bitte volständig dokumentieren
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C1883256
Beschreibung
Anemia
Datentyp
integer
Alias
- UMLS CUI [1]
- C0002871
Beschreibung
Thrombocytopenia
Datentyp
integer
Alias
- UMLS CUI [1]
- C0040034
Beschreibung
Leukopenia
Datentyp
integer
Alias
- UMLS CUI [1]
- C0023530
Beschreibung
Nausea/Vomiting
Datentyp
integer
Alias
- UMLS CUI [1]
- C0027498
Beschreibung
Mucositis
Datentyp
integer
Alias
- UMLS CUI [1]
- C0038362
Beschreibung
Intestines
Datentyp
integer
Alias
- UMLS CUI [1]
- C0021853
Beschreibung
Genitourinary system
Datentyp
integer
Alias
- UMLS CUI [1]
- C0042066
Beschreibung
Respiratory system
Datentyp
integer
Alias
- UMLS CUI [1]
- C0035237
Beschreibung
Fever, drug induced
Datentyp
integer
Alias
- UMLS CUI [1]
- C2830448
Beschreibung
Hypersensitivity
Datentyp
integer
Alias
- UMLS CUI [1]
- C0020517
Beschreibung
Heart
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018787
Beschreibung
Infection
Datentyp
integer
Alias
- UMLS CUI [1]
- C0009450
Beschreibung
Skin
Datentyp
integer
Alias
- UMLS CUI [1]
- C1123023
Beschreibung
Nervous system
Datentyp
integer
Alias
- UMLS CUI [1]
- C1269560
Beschreibung
Therapieänderungen
Beschreibung
Treatment changes during one of two cycles
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3665894
Beschreibung
Dose reduction
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1707814
Beschreibung
>14 Tage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1299700
Beschreibung
bei Abbruch bitte Abbruchbogen ausfüllen
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0457454
Beschreibung
If discontinued, reason
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C0457454
Beschreibung
Progressive Disease
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1335499
Beschreibung
Toxicity
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013221
Beschreibung
Patient wish
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0747309
Beschreibung
Other condition than Hodgkin lymphoma
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2707304
- UMLS CUI [1,2]
- C0332300
- UMLS CUI [1,3]
- C0019829
Beschreibung
If other condition, please specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2707304
- UMLS CUI [1,2]
- C1521902
Beschreibung
Comments
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Date of completion
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Beschreibung
Signature
Datentyp
text
Alias
- UMLS CUI [1]
- C1519316
Ähnliche Modelle
Deutsche Hodgkin Studiengruppe: G6C Chemotherapiebogen
- StudyEvent: ODM
C1515258 (UMLS CUI [1,2])
C1442065 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C1880049 (UMLS CUI [1,2])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
C0556971 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,2])
C0746883 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
C0332152 (UMLS CUI-2)
C3173309 (UMLS CUI-3)
C1883256 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,2])
C0332300 (UMLS CUI [1,2])
C0019829 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,2])