Combination Chemotherapy With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Interventions
- Biological: filgrastimDrug: CHOP regimenBiological: rituximabRadiation: radiation therapy
- Registration Number
- NCT00052936
- 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. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without rituximab in treating aggressive non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying how well giving cyclophosphamide, doxorubicin, vincristine, and prednisone together with or without rituximab works in treating older patients who have aggressive non-Hodgkin's lymphoma. (This trial is no longer randomized as of 6/2005).
- Detailed Description
OBJECTIVES:
Primary
* Compare the efficacy of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with vs without rituximab in elderly patients with aggressive non-Hodgkin's lymphoma.
* Compare the efficacy of 6 vs 8 courses of CHOP chemotherapy in patients treated with these regimens.
* Compare the rate of complete remission, rate of primary progression, tumor control, disease-free survival, overall survival, and relapse after radiotherapy in patients treated with these regimens.
* Compare the safety and side effects of these regimens in these patients.
Secondary
* Compare short-term and long-term side effects of these regimens in these patients.
* Compare quality of life of patients treated with these regimens.
* Compare the cost of these regimens in these patients.
* Determine relapse in patients treated with these regimens who received involved-field radiotherapy.
OUTLINE: This is a randomized (randomized part of study completed as of 6/2005), open-label, multicenter study. Patients are stratified according to participating center, value for serum lactic dehydrogenase (no greater than upper limit of normal \[ULN\] vs greater than ULN), bulky disease present (no vs yes), stage (I or II vs III or IV), general ECOG status of patient (0 or 1 vs 2), and age (61 to 70 vs 71-80). Patients are randomized to 1 of 4 treatment arms. Patients with CD20-negative lymphoma are randomized to arms I or II only.
* Prephase treatment:Patients receive vincristine IV on day -6 and prednisone on day -6 to day 0 before initiating CHOP chemotherapy.
* Arm I (closed to accrual as of 7/25/2005): Patients receive standard CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Patients also receive filgrastim (G-CSF) subcutaneously once daily on days 6-12 of each CHOP course. Treatment repeats every 2 weeks for 6 courses.
* Arm II (closed to accrual as of 7/25/2005): Patients receive standard CHOP chemotherapy and G-CSF as in arm I for a total of 8 courses.
* Arm III: Patients receive standard CHOP chemotherapy and G-CSF as in arm I. Patients also receive rituximab IV before CHOP every 2 weeks for a total of 8 courses.
* Arm IV (closed to accrual as of 7/25/2005): Patients receive standard CHOP chemotherapy and G-CSF as in arm II. Patients also receive rituximab IV before CHOP every 2 weeks for a total of 8 courses.
In all arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Beginning 3-6 weeks after completion of the last chemotherapy course, after complete recovery of bone marrow, and after complete remision of mucositis, patients with sites of initial bulky disease or extranodal involvement undergo radiotherapy 5 times a week for 4 weeks.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 1580 patients will be accrued for this study within 5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1506
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description S8 filgrastim 8x CHOP-14 R8 prednisone 8x CHOP-14 + 8x Rituximab S8 radiation therapy 8x CHOP-14 S6 CHOP regimen 6x CHOP-14 S6 prednisone 6x CHOP-14 R6 cyclophosphamide 6x CHOP-14 + 8x Rituximab R6 vincristine sulfate 6x CHOP-14 + 8x Rituximab R6 radiation therapy 6x CHOP-14 + 8x Rituximab S8 CHOP regimen 8x CHOP-14 S8 cyclophosphamide 8x CHOP-14 R8 filgrastim 8x CHOP-14 + 8x Rituximab R8 CHOP regimen 8x CHOP-14 + 8x Rituximab R8 vincristine sulfate 8x CHOP-14 + 8x Rituximab S6 vincristine sulfate 6x CHOP-14 R6 filgrastim 6x CHOP-14 + 8x Rituximab R8 radiation therapy 8x CHOP-14 + 8x Rituximab S6 filgrastim 6x CHOP-14 R6 CHOP regimen 6x CHOP-14 + 8x Rituximab S6 radiation therapy 6x CHOP-14 R6 rituximab 6x CHOP-14 + 8x Rituximab R6 prednisone 6x CHOP-14 + 8x Rituximab S8 prednisone 8x CHOP-14 S8 vincristine sulfate 8x CHOP-14 R8 rituximab 8x CHOP-14 + 8x Rituximab R8 cyclophosphamide 8x CHOP-14 + 8x Rituximab R8 doxorubicin hydrochloride 8x CHOP-14 + 8x Rituximab S6 doxorubicin hydrochloride 6x CHOP-14 S6 cyclophosphamide 6x CHOP-14 R6 doxorubicin hydrochloride 6x CHOP-14 + 8x Rituximab S8 doxorubicin hydrochloride 8x CHOP-14
- Primary Outcome Measures
Name Time Method Time to treatment failure at 3 years within the study and then periodically after study completion 3 years within the study and then periodically after study completion
- Secondary Outcome Measures
Name Time Method Complete response rate at 3 years within the study and then periodically after study completion 3 years within the study and then periodically after Progression rate 3 years within the study and then periodically after Survival 3 years within the study and then periodically after Tumor control 3 years within the study and then periodically after Disease-free survival 3 years within the study and then periodically after
Trial Locations
- Locations (163)
Onkologische Schwerpunktpraxis
🇩🇪Hildesheim, Germany
Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
🇩🇪Ansbach, Germany
General Hospital
🇩🇪Celle, Germany
Humaine - Clinic
🇩🇪Bad Saarow, Germany
Medizinische Universitaetsklinik I at the University of Cologne
🇩🇪Cologne, Germany
Carl - Thiem - Klinkum Cottbus
🇩🇪Cottbus, Germany
Municipal Hospital Complex
🇩🇪Villingen-Schwenningen, Germany
Robert - Koch Hospital
🇩🇪Gehrden, Germany
St. Johannes Hospital - Medical Klinik II
🇩🇪Duisburg, Germany
Hans - Susemihl - Krankenhaus
🇩🇪Emden, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Klinikum Frankfurt (Oder) GmbH
🇩🇪Frankfurt/Oder, Germany
Krankenhaus Nordwest
🇩🇪Frankfurt, Germany
Evang. Deaconess Hospital Freiburg
🇩🇪Freiburg, Germany
Medizinische Universitaetsklinik und Poliklinik
🇩🇪Heidelberg, Germany
Privatklinik Dr. R. Schindlbeck GmbH & Co. KG
🇩🇪Herrsching am Ammersee, Germany
Evang. Hospital
🇩🇪Holzminden, Germany
Gemeinschaftspraxis Innere Medizin
🇩🇪Jena, Germany
Staedtisches Klinikum Karlsruhe gGmbH
🇩🇪Karlsruhe, Germany
Praxis fuer Haematologie und Onkologie
🇩🇪Koblenz, Germany
St. Bonifatius Hospital Lingen
🇩🇪Lingen, Germany
Staedtisches Klinikum Magdeburg - Altstadt
🇩🇪Magdeburg, Germany
St. Marien Hospital - Muelheim an der Ruhr
🇩🇪Mulheim/Ruhr, Germany
Klinikum Ernst Von Bergmann
🇩🇪Potsdam, Germany
Deaconess Hospital
🇩🇪Schwabisch Hall, Germany
Evang. Jung-Stilling Hospital
🇩🇪Siegen, Germany
Diakonie Klinikum Stuttgart
🇩🇪Stuttgart, Germany
Klinik und Poliklinik fuer Strahlentherapie - Universitaetsklinikum Rostock
🇩🇪Rostock, Germany
Caritasklinik St. Theresia
🇩🇪Saarbrucken, Germany
Ev. Hospital Unna
🇩🇪Unna, Germany
Ev. Hospital Witten-Herdecke
🇩🇪Witten, Germany
University Wurzburg
🇩🇪Wurzburg, Germany
City Hospital Triemli
🇨ðŸ‡Zurich, Switzerland
Dr. Horst-Schmidt-Kliniken
🇩🇪Wiesbaden, Germany
UniversitaetsSpital Zuerich
🇨ðŸ‡Zurich, Switzerland
Haematologisch Onkologische Praxis
🇩🇪Aachen, Germany
II. Medizinische Klinik
🇩🇪Aschaffenburg, Germany
Specialist Practice for Oncology
🇩🇪Aschaffenburg, Germany
Haematologische Praxis
🇩🇪Augsburg, Germany
Klinikum Augsburg
🇩🇪Augsburg, Germany
Regional Hospital Bad Hersfeld
🇩🇪Bad Hersfeld, Germany
Krankenhaus Hohe Warte Mediziniche Klinik
🇩🇪Bayreuth, Germany
Saint Agnes Hospital
🇩🇪Bocholt, Germany
Krankenhaus Bietigheim
🇩🇪Bietigheim, Germany
Haematologisch-Onkologische Schwerpunktpraxis
🇩🇪Berlin, Germany
Hospital Complex Bernburg
🇩🇪Bernburg, Germany
Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
🇩🇪Berlin, Germany
Medizinische Poliklinik
🇩🇪Bonn, Germany
Rheinische Friedrich-Wilhelms-Universitat
🇩🇪Bonn, Germany
Saint Josef Hospital
🇩🇪Bochum, Germany
DIAKO Ev. Diakonie Krankenhaus gGmbH
🇩🇪Bremen, Germany
Medizinische Klinik Am Lukas - Krankenhaus
🇩🇪Bunde, Germany
Lung Clinic Cologne-Merheim
🇩🇪Cologne-Merheim, Germany
Hospital Kuchwald Chemnitz
🇩🇪Chemnitz, Germany
Praxis Fuer Haematologie Internistische Onkologie
🇩🇪Cologne, Germany
Klinikum Darmstadt
🇩🇪Darmstadt, Germany
Saint Johannes Hospital Dortmund
🇩🇪Dortmund, Germany
Universitatsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Florence-Nightingale-Krankenhause, Deaconess Kaiserswerth
🇩🇪Dusseldorf, Germany
Franz Hospital Dulmen
🇩🇪Dulmen, Germany
St. Antonius Hospital
🇩🇪Eschweiler, Germany
Centre for Internal Medicine Gieben
🇩🇪Gießen, Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
🇩🇪Greifswald, Germany
Staedtisches Klinikum Guetersloh
🇩🇪Gutersloh, Germany
Universitaetsklinikum Goettingen
🇩🇪Göttingen, Germany
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
🇩🇪Hagen, Germany
Allgemeines Krankenhaus Hagen
🇩🇪Hagen, Germany
Krankenhaus St. Elisabeth und St. Barbara
🇩🇪Halle/Saale, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH
🇩🇪Halle, Germany
Universitaetsklinikum Halle
🇩🇪Halle, Germany
University Medical Center Hamburg - Eppendorf
🇩🇪Hamburg, Germany
Asklepios Klinik Nord Heidberg
🇩🇪Hamburg, Germany
Allgemeines Krankenhaus Altona
🇩🇪Hamburg, Germany
Haematologisch-Onkologische Praxis Altona
🇩🇪Hamburg, Germany
Henriettenstiftung Krankenhaus
🇩🇪Hannover, Germany
Evangelische Krankenhaus Hamm
🇩🇪Hamm, Germany
Krankenhaus Siloah - Medizinische Klinik II
🇩🇪Hannover, Germany
Oncology Specialists Clinic
🇩🇪Harrislee, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Klinikum der Friedrich-Schiller Universitaet Jena
🇩🇪Jena, Germany
Red Cross Hospital Kassel
🇩🇪Kassel, Germany
University Leipzig Clinic of Internal Medicine
🇩🇪Leipzig, Germany
Klinikum "St. Georg" Leipzig
🇩🇪Leipzig, Germany
Dreifaltigkeits Hospital
🇩🇪Lippstadt, Germany
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
🇩🇪Magdeburg, Germany
Regional Hospital Mayen
🇩🇪Mayen, Germany
Kreiskrankenhaus Muenchberg
🇩🇪Munchberg, Germany
Klinikum der Universitaet Muenchen - Innenstadt Campus
🇩🇪Munich, Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
🇩🇪Munich, Germany
Munich Oncologic Practice at Elisenhof
🇩🇪Munich, Germany
Paracelsus - Klinik Osnabrueck
🇩🇪Osnabrück, Germany
Ev. Hospital Oldenburg
🇩🇪Oldenburg, Germany
Schwerpunktpraxis fuer Haematologie und Onkologie
🇩🇪Saarbruecken, Germany
St. Elizabeth-Klinik Saarlouis
🇩🇪Saarlouis, Germany
Klinikum Stuttgart - Buergerhospital
🇩🇪Stuttgart, Germany
Krankenhaus Barmherzigen Brueder
🇩🇪Trier, Germany
Hospital Tutzing
🇩🇪Tutzing, Germany
Hospital Wetzler
🇩🇪Wetzlar, Germany
St. Marienhospital - Vechta
🇩🇪Vechta, Germany
Regional Hospital Waldbrol
🇩🇪Waldbrol, Germany
Evangelisches Krankenhaus Essen Werden
🇩🇪Werden, Germany
Kliniken St. Antonius
🇩🇪Wuppertal, Germany
Municipal Hospital Complex Zwickau
🇩🇪Zwickau, Germany
Kreiskrankenhaus Aurich
🇩🇪Aurich, Germany
Robert-Bosch-Krankenhaus
🇩🇪Stuttgart, Germany
St. Elisabeth Hospital Thuine
🇩🇪Thuine, Germany
Klinikum St. Marien
🇩🇪Amberg, Germany
Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg
🇩🇪Augsburg, Germany
Knappschaft Krankenhaus
🇩🇪Bochum, Germany
Thoraxklinik Heidelberg
🇩🇪Heidelberg, Germany
Regional Hospital Am Plattenwald - Bad Friedrichshall
🇩🇪Heilbronn, Germany
Klinikum Krefeld GmbH
🇩🇪Krefeld, Germany
Caritas - Krakenhaus Lebach
🇩🇪Lebach, Germany
Klinikum Lippe - Lemgo
🇩🇪Lemgo, Germany
St. Vincenz Hospital Limburg
🇩🇪Limburg, Germany
Municipal Complex of Ludwigshafen
🇩🇪Ludwigshafen, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
🇩🇪Luebeck, Germany
Klinikum Minden
🇩🇪Minden, Germany
Municipal Hospital Munich
🇩🇪Munich, Germany
Klinikum Herford
🇩🇪Herford, Germany
Marienhospital at Ruhr University Bochum
🇩🇪Herne, Germany
Hospital Complex Hoyerswerda
🇩🇪Hoyerswerda, Germany
Staedtisches Krankenhaus Kiel
🇩🇪Kiel, Germany
Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH
🇩🇪Koblenz, Germany
Leonardis Clinic
🇩🇪Kornwestheim, Germany
Frankenwald Klinik
🇩🇪Kronach, Germany
Klinikum Erfurt
🇩🇪Erfurt, Germany
Regional Hospital Heidenheim
🇩🇪Heidenheim, Germany
Medical University Hospital Homburg
🇩🇪Homburg, Germany
Municipal Hospital Complex of the University
🇩🇪Kaiserslautern, Germany
Klinikum Ludwigsburg
🇩🇪Ludwigsburg, Germany
St. Marien Hospital Ludwighafen
🇩🇪Ludwigshafen, Germany
Johannes Gutenberg University
🇩🇪Mainz, Germany
Ev. Hospital Bethesda
🇩🇪Monchengladbach, Germany
Krankenhaus Muenchen Schwabing
🇩🇪Munich, Germany
Regional Hospital Neumarkt
🇩🇪Neumarkt, Germany
Klinikum Offenburg
🇩🇪Offenburg, Germany
III Medizinische Klinik Mannheim
🇩🇪Mannheim, Germany
Hospital Maria-Hilf II
🇩🇪Monchengladbach, Germany
Lukaskrankenhaus Neuss
🇩🇪Neuss, Germany
Klinikum Oldenburg
🇩🇪Oldenburg, Germany
Kreiskrankenhaus Radebeul
🇩🇪Radebeul, Germany
Hematologische Onkologische Praxis
🇩🇪Regensburg, Germany
Krankenhaus Barmherzige Brueder Regensburg
🇩🇪Regensburg, Germany
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
🇩🇪Rostock, Germany
Leopoldina - Krankenhaus
🇩🇪Schweinfurt, Germany
Klinik fuer Onkologie - Katharinenhospital Stuttgart
🇩🇪Stuttgart, Germany
Hospital Bad Cannstatt
🇩🇪Stuttgart, Germany
Krankenanstalt Mutterhaus der Borromaerinnen
🇩🇪Trier, Germany
Universitaetsklinikum Giessen und Marburg GmbH - Marburg
🇩🇪Marburg, Germany
Evangelisches Krankenhaus - Mulheim
🇩🇪Mulheim/Ruhr, Germany
Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
🇩🇪Munster, Germany
Staedtisches Klinikum Neunkirchen gGmbH
🇩🇪Neunkirchen, Germany
Klinikum Nuernberg - Klinikum Nord
🇩🇪Nuremberg, Germany
Hematologische Praxis
🇩🇪Oldenburg, Germany
Krankenhaus St. Elisabeth - Ravensburg
🇩🇪Ravensburg, Germany
Jakobi Krankenhaus
🇩🇪Rheine, Germany
St. Lukas - Clinic Solingen
🇩🇪Solingen, Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Klinikum der Universitaet Regensburg
🇩🇪Regensburg, Germany
Martin - Luther Hospital
🇩🇪Schleswig, Germany
Regional Hospital Traunstein
🇩🇪Traunstein, Germany
Deutsche Klinik fuer Diagnostik
🇩🇪Wiesbaden, Germany