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ID
21835
Beschrijving
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
Trefwoorden
Versies (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
Geüploaded op
3 mei 2017
DOI
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Licentie
Creative Commons BY-NC 3.0
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German Hodgkin Study Group Study HD16/HD17/HD18 Chemotherapy regimen G6C
Deutsche Hodgkin Studiengruppe: G6C Chemotherapiebogen
- StudyEvent: ODM
Similar models
Deutsche Hodgkin Studiengruppe: G6C Chemotherapiebogen
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Stamp of participating institution
Item
Stempel des einsendenden Instituts
text
C2347449 (UMLS CUI [1])
Phone number of participating institution
Item
Telefonnummer des einsendenden Instituts (bitte mit Durchwahl)
integer
C2347449 (UMLS CUI [1,1])
C1515258 (UMLS CUI [1,2])
C1515258 (UMLS CUI [1,2])
Address of responsible study center
Item
Adresse der verantwortlichen Studienzentrale
text
C2825181 (UMLS CUI [1,1])
C1442065 (UMLS CUI [1,2])
C1442065 (UMLS CUI [1,2])
Patient Name
Item
Patientenname
text
C1299487 (UMLS CUI [1])
Patient birth name
Item
Geburtsname
text
C1549652 (UMLS CUI [1])
Birth Date
Item
Geburtsdatum
date
C0421451 (UMLS CUI [1])
Patient address
Item
Adresse des Patienten
text
C0421449 (UMLS CUI [1])
CL Item
HD16 (1)
CL Item
HD17 (2)
CL Item
HD18 (3)
CRF Indentificator
Item
Bogen ID
integer
C1516308 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Case ID
Item
Case ID
integer
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Pre-cycle with dexamethasone
Item
Vorphase mit Dexamethason
boolean
C0011777 (UMLS CUI [1,1])
C1880049 (UMLS CUI [1,2])
C1880049 (UMLS CUI [1,2])
Cycle Number
Item
Kurs-Nr.
integer
C2045829 (UMLS CUI [1])
Treatment start date
Item
Erster Therapietag
date
C3173309 (UMLS CUI [1])
Treatment End date
Item
Letzter Therapietag
date
C1531784 (UMLS CUI [1])
Rituximab total dose per cycle
Item
Rituximab Gesamtdosis in mg/Zyklus
integer
C0393022 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
Rituximab cycle number
Item
Rituximab Zyklus Nr.
integer
C1302181 (UMLS CUI [1,1])
C0393022 (UMLS CUI [1,2])
C0393022 (UMLS CUI [1,2])
Cyclophosphamide total dose per cycle
Item
Cyclophosphamid Gesamtdosis in mg/Zyklus (Zyklus angeben)
integer
C0010583 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
Cyclophosphamide cycle number
Item
Cyclophosphamid Zyklus Nr.
integer
C1302181 (UMLS CUI [1,1])
C0010583 (UMLS CUI [1,2])
C0010583 (UMLS CUI [1,2])
Adriamycin total dose per cycle
Item
Adriamycin Gesamtdosis in mg/Zyklus (Zyklus angeben)
integer
C0085752 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
Adriamycin cycle number
Item
Adriamycin Zyklus Nr.
integer
C1302181 (UMLS CUI [1,1])
C0085752 (UMLS CUI [1,2])
C0085752 (UMLS CUI [1,2])
Etoposide/Etopophos. total dose per cycle
Item
Etoposid/Etopophos. Gesamtdosis in mg/Zyklus
integer
C0904036 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
Etoposide/Etopophos cycle number
Item
Etoposid/EtopophosZyklus Nr.
integer
C1302181 (UMLS CUI [1,1])
C0904036 (UMLS CUI [1,2])
C0904036 (UMLS CUI [1,2])
Procarbazine total dose per cycle
Item
Procarbazin Gesamtdosis in mg/Zyklus
integer
C0033223 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
Procarbazine cycle number
Item
Procarbazin Zyklus Nr.
integer
C1302181 (UMLS CUI [1,1])
C0033223 (UMLS CUI [1,2])
C0033223 (UMLS CUI [1,2])
Prednisone total dose per cycle
Item
Prednison Gesamtdosis in mg/Zyklus
integer
C0032952 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
Prednisone cycle number
Item
Prednison Zyklus Nr.
integer
C1302181 (UMLS CUI [1,1])
C0032952 (UMLS CUI [1,2])
C0032952 (UMLS CUI [1,2])
Vincristine total dose per cycle
Item
Vincristin Gesamtdosis in mg/Zyklus
integer
C0042679 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
Vincristine cycle number
Item
Vincristin Zyklus Nr.
integer
C1302181 (UMLS CUI [1,1])
C0042679 (UMLS CUI [1,2])
C0042679 (UMLS CUI [1,2])
Bleomycine total dose per cycle
Item
Bleomycin Gesamtdosis in mg/Zyklus
integer
C1589326 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
C2986497 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
Bleomycine cycle number
Item
Bleomycin Zyklus Nr.
integer
C1302181 (UMLS CUI [1,1])
C1589326 (UMLS CUI [1,2])
C1589326 (UMLS CUI [1,2])
GCSF
Item
G-CSF verabreicht
boolean
C0376562 (UMLS CUI [1])
GCSF number of days
Item
G-CSF Tage
integer
C0376562 (UMLS CUI [1,1])
C0556971 (UMLS CUI [1,2])
C0556971 (UMLS CUI [1,2])
Neupogen
Item
Neupogen
boolean
C0733468 (UMLS CUI [1])
Neulasta
Item
Neulasta
boolean
C1171279 (UMLS CUI [1])
Granocyte
Item
Granocyte
boolean
C0218640 (UMLS CUI [1])
Other GCSF
Item
Andere GCSF
boolean
C0079459 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Febrile Neutropenia
Item
Febrile Neutropenie
boolean
C0746883 (UMLS CUI [1])
Days of inpatient care because of febrile neutropenia
Item
Tage stationär wg. febriler Neutropenie
integer
C0019993 (UMLS CUI [1,1])
C0746883 (UMLS CUI [1,2])
C0746883 (UMLS CUI [1,2])
Leukopenia
Item
Leukos < 1000
boolean
C0023530 (UMLS CUI [1])
Days of Leukopenia
Item
Anzahl der Tage Leukos < 1000
integer
C0023530 (UMLS CUI [1,1])
C0556971 (UMLS CUI [1,2])
C0556971 (UMLS CUI [1,2])
Days with fever equal or higher 38°C
Item
Anzahl Tage mit Fieber größer oder gleich 38°C
integer
C1959900 (UMLS CUI [1,1])
C0556971 (UMLS CUI [1,2])
C0556971 (UMLS CUI [1,2])
Hemoglobin
Item
Hämoglobin
float
C0019046 (UMLS CUI [1])
Hemoglobin
Item
Hämoglobin
float
C0019046 (UMLS CUI [1])
WBC
Item
Leukozyten
float
C0023508 (UMLS CUI [1])
Platelets
Item
Thrombozyten
integer
C0005821 (UMLS CUI [1])
CTC Grade 3/4
Item
Systemische Therapie Nebenwirkungen CTC Grad 3/4
boolean
C1706735 (UMLS CUI [1])
Cycle number
Item
Kurs Nummer
integer
C2045829 (UMLS CUI [1])
CL Item
CTC3 (1)
CL Item
CTC4 (2)
CL Item
CTC3 (1)
CL Item
CTC4 (2)
CL Item
CTC3 (1)
CL Item
CTC4 (2)
CL Item
CTC3 (1)
CL Item
CTC4 (2)
CL Item
CTC3 (1)
CL Item
CTC4 (2)
CL Item
CTC3 (1)
CL Item
CTC4 (2)
CL Item
CTC3 (1)
CL Item
CTC4 (2)
CL Item
CTC3 (1)
CL Item
CTC4 (2)
CL Item
CTC3 (1)
CL Item
CTC4 (2)
CL Item
CTC3 (1)
CL Item
CTC4 (2)
CL Item
CTC3 (1)
CL Item
CTC4 (2)
CL Item
CTC3 (1)
CL Item
CTC4 (2)
CL Item
CTC3 (1)
CL Item
CTC4 (2)
CL Item
CTC3 (1)
CL Item
CTC4 (2)
Treatment changes during one of two cycles
Item
Gab es jeweils in einem der beiden Kurse eine Anderung?
boolean
C3665894 (UMLS CUI [1])
Dose reduction
Item
Dosisreduktion
boolean
C1707814 (UMLS CUI [1])
Therapy delay
Item
Therapieverzögerung
boolean
C1299700 (UMLS CUI [1])
Discontinuation
Item
Abbruch
boolean
C0457454 (UMLS CUI [1])
If discontinued, reason
Item
Falls ja, Begründung
text
C0566251 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,2])
Progressive Disease
Item
Progreß unter Therapie
boolean
C1335499 (UMLS CUI [1])
Toxicity
Item
Toxizität
boolean
C0013221 (UMLS CUI [1])
Patient wish
Item
Patientenwunsch
boolean
C0747309 (UMLS CUI [1])
Other condition than Hodgkin lymphoma
Item
HL unabhängige Erkrankung
boolean
C2707304 (UMLS CUI [1,1])
C0019829 (UMLS CUI [1,2])
C0019829 (UMLS CUI [1,2])
If other condition, please specify
Item
Wenn ja, welche?
text
C2707304 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
Comments
Item
Bemerkungen
text
C0947611 (UMLS CUI [1])
Date of completion
Item
Datum
date
C0011008 (UMLS CUI [1])
Signature
Item
Unterschrift
text
C1519316 (UMLS CUI [1])