Combination Chemotherapy Followed By Radiation Therapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Interventions
- Biological: filgrastimDrug: EPOCH regimenRadiation: radiation therapy
- Registration Number
- NCT00053768
- Lead Sponsor
- German High-Grade Non-Hodgkin's Lymphoma Study Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug and giving the drugs in different ways may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known which combination chemotherapy regimen followed by radiation therapy is more effective in treating aggressive non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens followed by radiation therapy to compare how well they work in treating patients with aggressive non-Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES:
* Compare the efficacy of standard-dose vs high-dose cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone followed by radiotherapy, in terms of time to treatment failure, in patients with aggressive non-Hodgkin's lymphoma.
* Compare the acute and long-term toxic effects of these regimens in these patients.
* Compare the complete response rate, survival and tumor control, and disease-free survival in patients treated with these regimens.
* Analyze the time to relapse after radiotherapy in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to LDH levels (no greater than upper limit of normal \[ULN\] vs greater than ULN), initial bulky disease (yes vs no), stage (I or II vs II or IV), ECOG performance status (0 or 1 vs 2 or 3), and participating center. Patients are randomized to 1 of 2 treatment arms as follows:
* Arm I (Standard dose): Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; etoposide IV on days 1-3; and oral prednisone on days 1-5 (CHOEP) in standard doses.
* Arm II (Escalated dose): Patients receive high-dose CHOEP as in arm I. Patients also receive filgrastim (G-CSF) subcutaneously on days 6-12.
In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of CHOEP chemotherapy, patients with initial bulky disease or extranodal involvement undergo radiotherapy 5 days a week for 4 weeks.
Patients who undergo radiotherapy are followed at 2 months after radiotherapy. All patients (including those who undergo radiotherapy) are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 389 patients were accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 392
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description high CHOEP-21 vincristine sulfate High-CHOEP-21-Schema: Cyclophosphamid (1400 mg/m2 i.v. d1), Doxorubicin (32,5 mg/m2 i.v. d1+2), Vincristin (2 mg i.v. d1), Etoposid (175 mg/m² i.v. d1-3), Prednison (100 mg p.o. d1-5) CHOEP-21 EPOCH regimen CHOEP-21-Schema: Cyclophosphamid (750 mg/m2 i.v. d1), Doxorubicin (50 mg/m2 i.v. d1), Vincristin (2 mg i.v. d1), Etoposid (100 mg/m² i.v. d1-3), Prednison (100 mg p.o. d1-5) CHOEP-21 filgrastim CHOEP-21-Schema: Cyclophosphamid (750 mg/m2 i.v. d1), Doxorubicin (50 mg/m2 i.v. d1), Vincristin (2 mg i.v. d1), Etoposid (100 mg/m² i.v. d1-3), Prednison (100 mg p.o. d1-5) high CHOEP-21 EPOCH regimen High-CHOEP-21-Schema: Cyclophosphamid (1400 mg/m2 i.v. d1), Doxorubicin (32,5 mg/m2 i.v. d1+2), Vincristin (2 mg i.v. d1), Etoposid (175 mg/m² i.v. d1-3), Prednison (100 mg p.o. d1-5) high CHOEP-21 radiation therapy High-CHOEP-21-Schema: Cyclophosphamid (1400 mg/m2 i.v. d1), Doxorubicin (32,5 mg/m2 i.v. d1+2), Vincristin (2 mg i.v. d1), Etoposid (175 mg/m² i.v. d1-3), Prednison (100 mg p.o. d1-5) CHOEP-21 vincristine sulfate CHOEP-21-Schema: Cyclophosphamid (750 mg/m2 i.v. d1), Doxorubicin (50 mg/m2 i.v. d1), Vincristin (2 mg i.v. d1), Etoposid (100 mg/m² i.v. d1-3), Prednison (100 mg p.o. d1-5) CHOEP-21 radiation therapy CHOEP-21-Schema: Cyclophosphamid (750 mg/m2 i.v. d1), Doxorubicin (50 mg/m2 i.v. d1), Vincristin (2 mg i.v. d1), Etoposid (100 mg/m² i.v. d1-3), Prednison (100 mg p.o. d1-5) high CHOEP-21 filgrastim High-CHOEP-21-Schema: Cyclophosphamid (1400 mg/m2 i.v. d1), Doxorubicin (32,5 mg/m2 i.v. d1+2), Vincristin (2 mg i.v. d1), Etoposid (175 mg/m² i.v. d1-3), Prednison (100 mg p.o. d1-5) CHOEP-21 doxorubicin hydrochloride CHOEP-21-Schema: Cyclophosphamid (750 mg/m2 i.v. d1), Doxorubicin (50 mg/m2 i.v. d1), Vincristin (2 mg i.v. d1), Etoposid (100 mg/m² i.v. d1-3), Prednison (100 mg p.o. d1-5) CHOEP-21 cyclophosphamide CHOEP-21-Schema: Cyclophosphamid (750 mg/m2 i.v. d1), Doxorubicin (50 mg/m2 i.v. d1), Vincristin (2 mg i.v. d1), Etoposid (100 mg/m² i.v. d1-3), Prednison (100 mg p.o. d1-5) CHOEP-21 etoposide CHOEP-21-Schema: Cyclophosphamid (750 mg/m2 i.v. d1), Doxorubicin (50 mg/m2 i.v. d1), Vincristin (2 mg i.v. d1), Etoposid (100 mg/m² i.v. d1-3), Prednison (100 mg p.o. d1-5) CHOEP-21 prednisone CHOEP-21-Schema: Cyclophosphamid (750 mg/m2 i.v. d1), Doxorubicin (50 mg/m2 i.v. d1), Vincristin (2 mg i.v. d1), Etoposid (100 mg/m² i.v. d1-3), Prednison (100 mg p.o. d1-5) high CHOEP-21 cyclophosphamide High-CHOEP-21-Schema: Cyclophosphamid (1400 mg/m2 i.v. d1), Doxorubicin (32,5 mg/m2 i.v. d1+2), Vincristin (2 mg i.v. d1), Etoposid (175 mg/m² i.v. d1-3), Prednison (100 mg p.o. d1-5) high CHOEP-21 doxorubicin hydrochloride High-CHOEP-21-Schema: Cyclophosphamid (1400 mg/m2 i.v. d1), Doxorubicin (32,5 mg/m2 i.v. d1+2), Vincristin (2 mg i.v. d1), Etoposid (175 mg/m² i.v. d1-3), Prednison (100 mg p.o. d1-5) high CHOEP-21 prednisone High-CHOEP-21-Schema: Cyclophosphamid (1400 mg/m2 i.v. d1), Doxorubicin (32,5 mg/m2 i.v. d1+2), Vincristin (2 mg i.v. d1), Etoposid (175 mg/m² i.v. d1-3), Prednison (100 mg p.o. d1-5) high CHOEP-21 etoposide High-CHOEP-21-Schema: Cyclophosphamid (1400 mg/m2 i.v. d1), Doxorubicin (32,5 mg/m2 i.v. d1+2), Vincristin (2 mg i.v. d1), Etoposid (175 mg/m² i.v. d1-3), Prednison (100 mg p.o. d1-5)
- Primary Outcome Measures
Name Time Method Time to treatment failure (TTF) at first relapse 3 years within study and periodically after study completion Time to Treatment failure using the Kaplan_Meier-Method
- Secondary Outcome Measures
Name Time Method Tumor control thought the treatment Calcution of treatment Duration using the Kaplan-Meier method
Complete response rate at first relapse 3 years within study and periodically after study completion Number of complete remission (CR) and unconfirmed complete Remission (CRu)
Survival time 3 years within study and periodically after study completion Time till death (whatever cause)
Disease-free survival 3 years within study and periodically after study completion Time of disease-free survivial
Trial Locations
- Locations (165)
Regional Hospital Traunstein
🇩🇪Traunstein, Germany
Hospital Tutzing
🇩🇪Tutzing, Germany
Krankenhaus Der Barmherzigen Brueder
🇩🇪Trier, Germany
St. Marienhospital - Vechta
🇩🇪Vechta, Germany
Klinikum Stuttgart - Buergerhospital
🇩🇪Stuttgart, Germany
St. Elisabeth Hospital Thuine
🇩🇪Thuine, Germany
Hospital Bad Cannstatt
🇩🇪Stuttgart, Germany
Robert-Bosch-Krankenhaus
🇩🇪Stuttgart, Germany
Municipal Hospital Complex Zwickau
🇩🇪Zwickau, Germany
Hospital Wetzler
🇩🇪Wetzlar, Germany
Ev. Hospital Unna
🇩🇪Unna, Germany
Klinikum Der Stadt Villingen - Schwenningen
🇩🇪Villingen-Schwenningen, Germany
Saint Josef Hospital
🇩🇪Bochum, Germany
Medizinische Poliklinik
🇩🇪Bonn, Germany
Klinikum Augsburg
🇩🇪Augsburg, Germany
Rheinische Friedrich-Wilhelms-Universitat
🇩🇪Bonn, Germany
Haematologisch Onkologische Praxis
🇩🇪Aachen, Germany
Kreiskrankenhaus
🇩🇪Bad Hersfeld, Germany
Robert - Koch Hospital
🇩🇪Gehrden, Germany
General Hospital
🇩🇪Celle, Germany
Charite - Campus Charite Mitte
🇩🇪Berlin, Germany
Hans - Susemihl - Krankenhaus
🇩🇪Emden, Germany
II. Medizinische Klinik
🇩🇪Aschaffenburg, Germany
DIAKO Ev. Diakonie Krankenhaus gGmbH
🇩🇪Bremen, Germany
Franz Hospital Dulmen
🇩🇪Dulmen, Germany
Specialist Practice for Oncology
🇩🇪Aschaffenburg, Germany
Knappschaft Krankenhaus
🇩🇪Bochum, Germany
Saint Johannes Hospital Dortmund
🇩🇪Dortmund, Germany
Humaine - Clinic
🇩🇪Bad Saarow, Germany
Hospital Complex Bernburg
🇩🇪Bernburg, Germany
Klinikum St. Marien
🇩🇪Amberg, Germany
Haematologische Praxis
🇩🇪Augsburg, Germany
Klinikum Darmstadt
🇩🇪Darmstadt, Germany
St. Johannes Hospital - Medical Klinik II
🇩🇪Duisburg, Germany
Onkolog - Haematolog Schwerpunktpraxis
🇩🇪Berlin, Germany
Universitatsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Staedtisches Klinikum Guetersloh
🇩🇪Gutersloh, Germany
Hospital Kuchwald Chemnitz
🇩🇪Chemnitz, Germany
Allgemeines Krankenhaus Altona
🇩🇪Hamburg, Germany
Thoraxklinik Heidelberg
🇩🇪Heidelberg, Germany
Krankenhaus Siloah - Medizinische Klinik II
🇩🇪Hannover, Germany
Regional Hospital Am Plattenwald - Bad Friedrichhall
🇩🇪Heilbronn, Germany
Staedtisches Klinikum Karlsruhe gGmbH
🇩🇪Karlsruhe, Germany
Leonardis Clinic
🇩🇪Kornwestheim, Germany
Red Cross Hospital Kassel
🇩🇪Kassel, Germany
Klinikum der Stadt Ludwigshafen am Rhein
🇩🇪Ludwigshafen, Germany
Klinik fuer Onkologie - Katharinenhospital Stuttgart
🇩🇪Stuttgart, Germany
Johannes Gutenberg University
🇩🇪Mainz, Germany
Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
🇩🇪Ansbach, Germany
Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg
🇩🇪Augsburg, Germany
Kreiskrankenhaus Aurich
🇩🇪Aurich, Germany
Krankenhaus Hohe Warte Mediziniche Klinik
🇩🇪Bayreuth, Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
🇩🇪Greifswald, Germany
Evangelische Krankenhaus Hamm
🇩🇪Hamm, Germany
Oncology Specialists Clinic
🇩🇪Harrislee, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Onkologische Schwerpunktpraxis
🇩🇪Hildesheim, Germany
Evang. Hospital
🇩🇪Holzminden, Germany
Hospital Complex Hoyerswerda
🇩🇪Hoyerswerda, Germany
Gemeinschaftspraxis Innere Medizin
🇩🇪Jena, Germany
Medizinische Klinik und Poliklinik III - Universitaetsklinikum Leipzig
🇩🇪Leipzig, Germany
Klinikum Ludwigsburg
🇩🇪Ludwigsburg, Germany
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
🇩🇪Magdeburg, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
🇩🇪Luebeck, Germany
Klinikum Minden
🇩🇪Minden, Germany
Klinikum der Universitaet Muenchen - Innenstadt Campus
🇩🇪Munchen, Germany
Munich Oncologic Practice at Elisenhof
🇩🇪Munchen, Germany
Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
🇩🇪Munster, Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
🇩🇪Munich, Germany
Krankenhaus Muenchen Schwabing
🇩🇪Munich, Germany
Evangelisches Krankenhaus - Mülheim
🇩🇪Mülheim, Germany
Lukaskrankenhaus Neuss
🇩🇪Neuss, Germany
Regional Hospital Neumarkt
🇩🇪Neumarkt, Germany
Staedtisches Klinikum Neunkirchen gGmbH
🇩🇪Neunkirchen, Germany
Klinikum Nuernberg - Klinikum Nord
🇩🇪Nurnberg, Germany
Klinikum Offenburg
🇩🇪Offenburg, Germany
Hematologische Praxis
🇩🇪Oldenburg, Germany
Krankenhaus St. Elisabeth - Ravensburg
🇩🇪Ravensburg, Germany
Hematologische Onkologische Praxis
🇩🇪Regensburg, Germany
Ev. Hospital Oldenburg
🇩🇪Oldenburg, Germany
Klinikum Oldenburg
🇩🇪Oldenburg, Germany
Paracelsus - Klinik Osnabrück
🇩🇪Osnabrück, Germany
Klinikum Ernst Von Bergmann
🇩🇪Potsdam, Germany
Klinikum der Universitaet Regensburg
🇩🇪Regensburg, Germany
Krankenhaus Barmherzige Brueder Regensburg
🇩🇪Regensburg, Germany
Jakobi Krankenhaus
🇩🇪Rheine, Germany
Klinik und Poliklinik fuer Strahlentherapie - Universitaetsklinikum Rostock
🇩🇪Rostock, Germany
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
🇩🇪Rostock, Germany
Caritasklinik St. Theresia
🇩🇪Saarbrucken, Germany
St. Elizabeth-Klinik Saarlouis
🇩🇪Saarlouis, Germany
Martin - Luther Hospital
🇩🇪Schleswig, Germany
Evang. Jung-Stilling Hospital
🇩🇪Siegen, Germany
Deaconess Hospital
🇩🇪Schwabisch Hall, Germany
Leopoldina - Krankenhaus
🇩🇪Schweinfurt, Germany
St. Lukas - Clinic Solingen
🇩🇪Solingen, Germany
Deutsche Klinik fuer Diagnostik
🇩🇪Wiesbaden, Germany
Dr. Horst-Schmidt-Kliniken
🇩🇪Wiesbaden, Germany
Ev. Hospital Witten-Herdecke
🇩🇪Witten, Germany
Kliniken St. Antonius
🇩🇪Wuppertal, Germany
UniversitaetsSpital Zuerich
🇨🇭Zurich, Switzerland
City Hospital Triemli
🇨🇭Zurich, Switzerland
Krankenhaus Bietigheim
🇩🇪Bietigheim, Germany
Saint Agnes Hospital
🇩🇪Bocholt, Germany
Florence-Nightingale-Krankenhause, Deaconess Kaiserswerth
🇩🇪Duesseldorf, Germany
Medizinische Klinik Am Lukas - Krankenhaus
🇩🇪Bunde, Germany
Carl - Thiem - Klinkum Cottbus
🇩🇪Cottbus, Germany
Klinikum Erfurt
🇩🇪Erfurt, Germany
St. Antonius Hospital
🇩🇪Eschweiler, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Evangelisches Krankenhaus Essen-Werden
🇩🇪Essen, Germany
Klinikum Frankfurt (Oder) GmbH
🇩🇪Frankfurt/Oder, Germany
Evang. Deaconess Hospital Freiburg
🇩🇪Freiburg, Germany
Krankenhaus Nordwest
🇩🇪Frankfurt, Germany
Municipal Hospital Complex
🇩🇪Pforzheim, Germany
Universitaetsklinikum Göttingen
🇩🇪Göttingen, Germany
Centre for Internal Medicine Gießen
🇩🇪Gießen, Germany
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
🇩🇪Hagen, Germany
Klinikum Herford
🇩🇪Herford, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH
🇩🇪Halle, Germany
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Allgemeines Krankenhaus Hagen
🇩🇪Hagen, Germany
Krankenhaus St. Elisabeth und St. Barbara
🇩🇪Halle/Saale, Germany
Henriettenstiftung Krankenhaus
🇩🇪Hannover, Germany
Haematologisch-Onkologische Praxis Altona
🇩🇪Hamburg, Germany
Universitaetsklinikum Halle
🇩🇪Halle, Germany
Kliniken der Stadt Koeln gGmbH - Krankenhaus Merheim
🇩🇪Koln-Merheim, Germany
Praxis Fuer Haematologie Internistische Onkologie
🇩🇪Koln, Germany
Medizinische Universitaetsklinik I at the University of Cologne
🇩🇪Koln, Germany
St. Vincenz Hospital Limburg
🇩🇪Limburg, Germany
Klinikum Lippe - Lemgo
🇩🇪Lemgo, Germany
Frankenwald Klinik
🇩🇪Kronach, Germany
Asklepios Klinik Nord Heidberg
🇩🇪Hamburg, Germany
Regional Hospital Heidenheim
🇩🇪Heidenheim, Germany
Marienhospital at Ruhr University Bochum
🇩🇪Herne, Germany
Privatklinik Dr. R. Schindlbeck GmbH & Co. KG
🇩🇪Herrsching Am Ammersee, Germany
Klinikum der Friedrich-Schiller Universitaet Jena
🇩🇪Jena, Germany
Municipal Hospital Complex of the University
🇩🇪Kaiserslautern, Germany
Staedtisches Krankenhaus Kiel
🇩🇪Kiel, Germany
Praxis fuer Haematologie und Onkologie
🇩🇪Koblenz, Germany
Klinikum Krefeld GmbH
🇩🇪Krefeld, Germany
Caritas - Krakenhaus Lebach
🇩🇪Lebach, Germany
University Leipzig Clinic of Internal Medicine
🇩🇪Leipzig, Germany
Medizinische Universitaetsklinik und Poliklinik
🇩🇪Heidelberg, Germany
Krankenanstalt Mutterhaus der Borromaerinnen
🇩🇪Trier, Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Medical University Hospital Homburg
🇩🇪Homburg, Germany
Universitaetsklinikum des Saarlandes
🇩🇪Homburg, Germany
German CML Study Group
🇩🇪Manheim, Germany
Staedtisches Klinikum Magdeburg - Altstadt
🇩🇪Magdeburg, Germany
St. Marien Hospital Ludwighafen
🇩🇪Ludwigshafen, Germany
Philipps-Universitaet Marburg Klinikum
🇩🇪Marburg, Germany
Regional Hospital Mayen
🇩🇪Mayen, Germany
Ev. Hospital Bethesda
🇩🇪Monchenglabach, Germany
Hospital Maria-Hilf II
🇩🇪Monchengladbach, Germany
St. Marien Hospital - Muelheim an der Ruhr
🇩🇪Mulheim/Ruhr, Germany
Kreiskrankenhaus Muenchberg
🇩🇪Munchberg, Germany
Schwerpunktpraxis fuer Haematologie und Onkologie
🇩🇪Saarbrucken, Germany
Diakonie Klinikum Stuttgart
🇩🇪Stuttgart, Germany
Regional Hospital Waldbrol
🇩🇪Waldbrol, Germany
University Wurzburg
🇩🇪Wuerzburg, Germany
Dreifaltigkeits Hospital
🇩🇪Lippstadt, Germany
Staedtisches Klinikum "St. Georg" Leipzig
🇩🇪Leipzig, Germany
Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH
🇩🇪Koblenz, Germany
St. Bonifatius Hospital Lingen
🇩🇪Lingen, Germany
Kreiskrankenhaus Radebeul
🇩🇪Radebeul, Germany