Combination Chemotherapy Followed By Radiation Therapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma

NCT00053768 | Completed Phase 3

• 3 other identifiers: CDR0000269371DSHNHL-1999-2EU-20242
• Study Type: interventional
• Target: 392
• Locations: 2 countries
• Sites: 175

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.

Conditions

Lymphoma

Keywords

contiguous stage II grade 3 follicular lymphoma; noncontiguous stage II grade 3 follicular lymphoma; stage I grade 3 follicular lymphoma; stage III grade 3 follicular lymphoma; stage IV grade 3 follicular lymphoma; contiguous stage II adult diffuse mixed cell lymphoma; noncontiguous stage II adult diffuse mixed cell lymphoma; stage I adult diffuse mixed cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage IV adult diffuse mixed cell lymphoma; contiguous stage II adult diffuse large cell lymphoma; contiguous stage II adult Burkitt lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult Burkitt lymphoma; stage I adult diffuse large cell lymphoma; stage I adult Burkitt lymphoma; stage III adult diffuse large cell lymphoma; stage III adult Burkitt lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult Burkitt lymphoma; contiguous stage II adult immunoblastic large cell lymphoma; noncontiguous stage II adult immunoblastic large cell lymphoma; stage I adult immunoblastic large cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; contiguous stage II adult lymphoblastic lymphoma; noncontiguous stage II adult lymphoblastic lymphoma; stage I adult lymphoblastic lymphoma; stage III adult lymphoblastic lymphoma; stage IV adult lymphoblastic lymphoma; contiguous stage II mantle cell lymphoma; noncontiguous stage II mantle cell lymphoma; stage I mantle cell lymphoma; stage III mantle cell lymphoma; stage IV mantle cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Time to treatment failure (TTF) at first relapse

  Time to Treatment failure using the Kaplan\_Meier-Method

  3 years within study and periodically after study completion

Secondary Outcomes (4)

• Complete response rate at first relapse

  3 years within study and periodically after study completion

• Survival time

  3 years within study and periodically after study completion

• Tumor control

  thought the treatment

• Disease-free survival

  3 years within study and periodically after study completion

Study Arms (2)

CHOEP-21

ACTIVE COMPARATOR

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)

Biological: filgrastim; Drug: EPOCH regimen; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: prednisone; Drug: vincristine sulfate; Radiation: radiation therapy

high CHOEP-21

EXPERIMENTAL

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)

Biological: filgrastim; Drug: EPOCH regimen; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: prednisone; Drug: vincristine sulfate; Radiation: radiation therapy

Interventions

filgrastim BIOLOGICAL

CHOEP-21; high CHOEP-21

EPOCH regimen DRUG

CHOEP-21; high CHOEP-21

cyclophosphamide DRUG

CHOEP-21; high CHOEP-21

doxorubicin hydrochloride DRUG

CHOEP-21; high CHOEP-21

etoposide DRUG

CHOEP-21; high CHOEP-21

prednisone DRUG

CHOEP-21; high CHOEP-21

vincristine sulfate DRUG

CHOEP-21; high CHOEP-21

radiation therapy RADIATION

CHOEP-21; high CHOEP-21

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically confirmed aggressive non-Hodgkin's lymphoma * Previously untreated disease * Favorable prognosis * International Prognostic Index score of 0-1 * No more than 25% marrow involvement PATIENT CHARACTERISTICS: Age * 18 to 60 Performance status * ECOG 0-3 OR * Karnofsky 40-100% Life expectancy * Not specified Hematopoietic * Platelet count at least 100,000/mm\^3 * WBC at least 2,500/mm\^3 Hepatic * No active hepatitis infection Renal * Not specified Other * HIV negative * Not pregnant or nursing * No relevant accompanying disease * No other concurrent malignancy * No contraindications to any study medications * No prior noncompliance by patient PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy Surgery * Not specified Other * No other concurrent participation in another treatment study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• German High-Grade Non-Hodgkin's Lymphoma Study Group: lead

Study Sites (175)

Haematologisch Onkologische Praxis

Aachen, 52070, Germany

Location

Klinikum St. Marien

Amberg, D-92224, Germany

Location

Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie

Ansbach, D-91522, Germany

Location

Specialist Practice for Oncology

Aschaffenburg, 63739, Germany

Location

II. Medizinische Klinik

Aschaffenburg, D-63739, Germany

Location

Haematologische Praxis

Augsburg, 86150, Germany

Location

Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg

Augsburg, 86150, Germany

Location

Klinikum Augsburg

Augsburg, D-86156, Germany

Location

Kreiskrankenhaus Aurich

Aurich, D-26603, Germany

Location

Kreiskrankenhaus

Bad Hersfeld, D-36251, Germany

Location

Humaine - Clinic

Bad Saarow, D-15526, Germany

Location

Krankenhaus Hohe Warte Mediziniche Klinik

Bayreuth, D-95445, Germany

Location

Onkolog - Haematolog Schwerpunktpraxis

Berlin, 13357, Germany

Location

Charite - Campus Charite Mitte

Berlin, D-13125, Germany

Location

Hospital Complex Bernburg

Bernburg, D-06406, Germany

Location

Krankenhaus Bietigheim

Bietigheim, D-74319, Germany

Location

Saint Agnes Hospital

Bocholt, D-46397, Germany

Location

Saint Josef Hospital

Bochum, D-44791, Germany

Location

Knappschaft Krankenhaus

Bochum, D-44892, Germany

Location

Medizinische Poliklinik

Bonn, D-53111, Germany

Location

Rheinische Friedrich-Wilhelms-Universitat

Bonn, D-53113, Germany

Location

DIAKO Ev. Diakonie Krankenhaus gGmbH

Bremen, D-28239, Germany

Location

Medizinische Klinik Am Lukas - Krankenhaus

Bünde, D-32257, Germany

Location

General Hospital

Celle, D-29223, Germany

Location

Hospital Kuchwald Chemnitz

Chemnitz, D-09113, Germany

Location

Praxis Fuer Haematologie Internistische Onkologie

Cologne, D-50677, Germany

Location

Medizinische Universitaetsklinik I at the University of Cologne

Cologne, D-50924, Germany

Location

Unknown Facility

Cologne-Kalk, D-51105, Germany

Location

Carl - Thiem - Klinkum Cottbus

Cottbus, D-03048, Germany

Location

Klinikum Darmstadt

Darmstadt, D-64283, Germany

Location

Saint Johannes Hospital Dortmund

Dortmund, D-44137, Germany

Location

Universitatsklinikum Carl Gustav Carus

Dresden, D-01307, Germany

Location

St. Johannes Hospital - Medical Klinik II

Duisburg, D-47166, Germany

Location

Franz Hospital Dulmen

Dülmen, D-48249, Germany

Location

Florence-Nightingale-Krankenhause, Deaconess Kaiserswerth

Düsseldorf, D-40489, Germany

Location

Hans - Susemihl - Krankenhaus

Emden, D-26721, Germany

Location

Klinikum Erfurt

Erfurt, 99089, Germany

Location

St. Antonius Hospital

Eschweiler, 52249, Germany

Location

Universitaetsklinikum Essen

Essen, D-45147, Germany

Location

Evangelisches Krankenhaus Essen-Werden

Essen, D-45239, Germany

Location

Krankenhaus Nordwest

Frankfurt, 60488, Germany

Location

Klinikum Frankfurt (Oder) GmbH

Frankfurt (Oder), 15236, Germany

Location

Evang. Deaconess Hospital Freiburg

Freiburg im Breisgau, D-79110, Germany

Location

Municipal Hospital Complex

Fulda, 36043, Germany

Location

Robert - Koch Hospital

Gehrden, 30989, Germany

Location

Centre for Internal Medicine Gießen

Giessen, D-35392, Germany

Location

Universitaetsklinikum Göttingen

Göttingen, D-37075, Germany

Location

Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

Greifswald, D-17489, Germany

Location

Staedtisches Klinikum Guetersloh

Gütersloh, 33332, Germany

Location

St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH

Hagen, 58095, Germany

Location

Allgemeines Krankenhaus Hagen

Hagen, D-58095, Germany

Location

Krankenhaus St. Elisabeth und St. Barbara

Halle, 06110, Germany

Location

Krankenhaus Martha-Maria Halle-Doelau gGmbH

Halle, 06120, Germany

Location

Universitaetsklinikum Halle

Halle, D-06097, Germany

Location

Unknown Facility

Hamburg, 20095, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, D-20251, Germany

Location

Asklepios Klinik Nord Heidberg

Hamburg, D-22413, Germany

Location

Allgemeines Krankenhaus Altona

Hamburg, D-22763, Germany

Location

Haematologisch-Onkologische Praxis Altona

Hamburg, D-22767, Germany

Location

Evangelische Krankenhaus Hamm

Hamm, D-59063, Germany

Location

Unknown Facility

Hanover, 30159, Germany

Location

Krankenhaus Siloah - Medizinische Klinik II

Hanover, 30449, Germany

Location

Henriettenstiftung Krankenhaus

Hanover, 30559, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Oncology Specialists Clinic

Harrislee, D-24955, Germany

Location

Medizinische Universitaetsklinik und Poliklinik

Heidelberg, 69115, Germany

Location

Thoraxklinik Heidelberg

Heidelberg, D-69126, Germany

Location

Regional Hospital Heidenheim

Heidenheim, 89522, Germany

Location

Regional Hospital Am Plattenwald - Bad Friedrichhall

Heilbronn, D-74172, Germany

Location

Klinikum Herford

Herford, 32049, Germany

Location

Marienhospital at Ruhr University Bochum

Herne, 44625, Germany

Location

Privatklinik Dr. R. Schindlbeck GmbH & Co. KG

Herrsching am Ammersee, D-82211, Germany

Location

Onkologische Schwerpunktpraxis

Hildesheim, 31134, Germany

Location

Evang. Hospital

Holzminden, D-37603, Germany

Location

Medical University Hospital Homburg

Homburg, 66421, Germany

Location

Universitaetsklinikum des Saarlandes

Homburg, D-66424, Germany

Location

Hospital Complex Hoyerswerda

Hoyerswerda, D-02977, Germany

Location

Gemeinschaftspraxis Innere Medizin

Jena, D-07743, Germany

Location

Klinikum der Friedrich-Schiller Universitaet Jena

Jena, D-07747, Germany

Location

Municipal Hospital Complex of the University

Kaiserslautern, D-67655, Germany

Location

Staedtisches Klinikum Karlsruhe gGmbH

Karlsruhe, D-76133, Germany

Location

Red Cross Hospital Kassel

Kassel, D-34121, Germany

Location

Staedtisches Krankenhaus Kiel

Kiel, D-23116, Germany

Location

Praxis fuer Haematologie und Onkologie

Koblenz, D-56068, Germany

Location

Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH

Koblenz, D-56068, Germany

Location

Kliniken der Stadt Koeln gGmbH - Krankenhaus Merheim

Koln-Merheim, D-51109, Germany

Location

Leonardis Clinic

Kornwestheim, D-70806, Germany

Location

Klinikum Krefeld GmbH

Krefeld, D-47805, Germany

Location

Frankenwald Klinik

Kronach, D-96317, Germany

Location

Caritas - Krakenhaus Lebach

Lebach, D-66822, Germany

Location

Medizinische Klinik und Poliklinik III - Universitaetsklinikum Leipzig

Leipzig, D-04103, Germany

Location

University Leipzig Clinic of Internal Medicine

Leipzig, D-04103, Germany

Location

Unknown Facility

Leipzig, D-04103, Germany

Location

Staedtisches Klinikum "St. Georg" Leipzig

Leipzig, D-04129, Germany

Location

Klinikum Lippe - Lemgo

Lemgo, D-32657, Germany

Location

St. Vincenz Hospital Limburg

Limburg, D-65549, Germany

Location

St. Bonifatius Hospital Lingen

Lingen, D-49808, Germany

Location

Dreifaltigkeits Hospital

Lippstadt, D-59555, Germany

Location

Klinikum Ludwigsburg

Ludwigsburg, D-71460, Germany

Location

Klinikum der Stadt Ludwigshafen am Rhein

Ludwigshafen, D-67063, Germany

Location

St. Marien Hospital Ludwighafen

Ludwigshafen, D-67067, Germany

Location

Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

Lübeck, D-23538, Germany

Location

Staedtisches Klinikum Magdeburg - Altstadt

Magdeburg, D-39104, Germany

Location

Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

Magdeburg, D-39120, Germany

Location

Johannes Gutenberg University

Mainz, D-55131, Germany

Location

German CML Study Group

Manheim, D-68305, Germany

Location

Unknown Facility

Marburg, D-35037, Germany

Location

Philipps-Universitaet Marburg Klinikum

Marburg, D-35043, Germany

Location

Regional Hospital Mayen

Mayen, D-56727, Germany

Location

Klinikum Minden

Minden, D-32423, Germany

Location

Unknown Facility

Minden, D-32427, Germany

Location

Ev. Hospital Bethesda

Monchenglabach, D-41061, Germany

Location

Unknown Facility

Monchenglasbach/Rheydt, D-41239, Germany

Location

Hospital Maria-Hilf II

Mönchengladbach, D-41063, Germany

Location

Krankenhaus Muenchen Schwabing

Munich, D-80804, Germany

Location

Klinikum der Universitaet Muenchen - Grosshadern Campus

Munich, D-81377, Germany

Location

Evangelisches Krankenhaus - Mülheim

Mülheim, D-45466, Germany

Location

St. Marien Hospital - Muelheim an der Ruhr

Mülheim, D-45468, Germany

Location

Kreiskrankenhaus Muenchberg

Münchberg, D-95213, Germany

Location

Munich Oncologic Practice at Elisenhof

München, D-80335, Germany

Location

Klinikum der Universitaet Muenchen - Innenstadt Campus

München, D-80336, Germany

Location

Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster

Münster, D-48129, Germany

Location

Regional Hospital Neumarkt

Neumarkt, D-92318, Germany

Location

Staedtisches Klinikum Neunkirchen gGmbH

Neunkirchen, D-66538, Germany

Location

Lukaskrankenhaus Neuss

Neuss, D-41464, Germany

Location

Klinikum Nuernberg - Klinikum Nord

Nuremberg, D-90340, Germany

Location

Klinikum Offenburg

Offenburg, D-77654, Germany

Location

Hematologische Praxis

Oldenburg, D-26121, Germany

Location

Ev. Hospital Oldenburg

Oldenburg, D-26122, Germany

Location

Klinikum Oldenburg

Oldenburg, D-26133, Germany

Location

Paracelsus - Klinik Osnabrück

Osnabrück, D-49076, Germany

Location

Municipal Hospital Complex

Pforzheim, D-49 7231 9690, Germany

Location

Klinikum Ernst Von Bergmann

Potsdam, D-14467, Germany

Location

Kreiskrankenhaus Radebeul

Radebeul, D-01445, Germany

Location

Krankenhaus St. Elisabeth - Ravensburg

Ravensburg, D-88212, Germany

Location

Klinikum der Universitaet Regensburg

Regensburg, D-93042, Germany

Location

Hematologische Onkologische Praxis

Regensburg, D-93047, Germany

Location

Krankenhaus Barmherzige Brueder Regensburg

Regensburg, D-93049, Germany

Location

Jakobi Krankenhaus

Rheine, D-48431, Germany

Location

Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock

Rostock, D-18057, Germany

Location

Klinik und Poliklinik fuer Strahlentherapie - Universitaetsklinikum Rostock

Rostock, D-18057, Germany

Location

Unknown Facility

Rostock, D-18257, Germany

Location

Caritasklinik St. Theresia

Saarbrücken, D-66113, Germany

Location

Schwerpunktpraxis fuer Haematologie und Onkologie

Saarbrücken, D-66113, Germany

Location

St. Elizabeth-Klinik Saarlouis

Saarlouis, D-66713, Germany

Location

Martin - Luther Hospital

Schleswig, D-24837, Germany

Location

Deaconess Hospital

Schwäbisch Hall, D-74523, Germany

Location

Leopoldina - Krankenhaus

Schweinfurt, D-97422, Germany

Location

Evang. Jung-Stilling Hospital

Siegen, D-57074, Germany

Location

St. Lukas - Clinic Solingen

Solingen, D-42697, Germany

Location

Klinik fuer Onkologie - Katharinenhospital Stuttgart

Stuttgart, D-70174, Germany

Location

Diakonie Klinikum Stuttgart

Stuttgart, D-70176, Germany

Location

Klinikum Stuttgart - Buergerhospital

Stuttgart, D-70191, Germany

Location

Hospital Bad Cannstatt

Stuttgart, D-70374, Germany

Location

Robert-Bosch-Krankenhaus

Stuttgart, D-70376, Germany

Location

St. Elisabeth Hospital Thuine

Thuine, D-49832, Germany

Location

Regional Hospital Traunstein

Traunstein, D-83278, Germany

Location

Krankenanstalt Mutterhaus der Borromaerinnen

Trier, D-54290, Germany

Location

Unknown Facility

Trier, D-54290, Germany

Location

Krankenhaus Der Barmherzigen Brueder

Trier, D-54292, Germany

Location

Hospital Tutzing

Tutzing, D-82327, Germany

Location

Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

Ulm, D-89081, Germany

Location

Ev. Hospital Unna

Unna, D-59403, Germany

Location

St. Marienhospital - Vechta

Vechta, D-49377, Germany

Location

Klinikum Der Stadt Villingen - Schwenningen

Villingen-Schwenningen, D-78045, Germany

Location

Regional Hospital Waldbrol

Waldbröl, D-51545, Germany

Location

Hospital Wetzler

Wetzlar, D-35578, Germany

Location

Deutsche Klinik fuer Diagnostik

Wiesbaden, D-65191, Germany

Location

Dr. Horst-Schmidt-Kliniken

Wiesbaden, D-65199, Germany

Location

Ev. Hospital Witten-Herdecke

Witten, D-58455, Germany

Location

Kliniken St. Antonius

Wuppertal, D-42283, Germany

Location

University Wurzburg

Würzburg, D-97070, Germany

Location

Municipal Hospital Complex Zwickau

Zwickau, D-08060, Germany

Location

UniversitaetsSpital Zuerich

Zurich, CH-8091, Switzerland

Location

City Hospital Triemli

Zurich, D-8063, Switzerland

Location

Related Publications (2)

• Trumper L, Zwick C, Ziepert M, Hohloch K, Schmits R, Mohren M, Liersch R, Bentz M, Graeven U, Wruck U, Hoffmann M, Metzner B, Hasenclever D, Loeffler M, Pfreundschuh M; German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL). Dose-escalated CHOEP for the treatment of young patients with aggressive non-Hodgkin's lymphoma: I. A randomized dose escalation and feasibility study with bi- and tri-weekly regimens. Ann Oncol. 2008 Mar;19(3):538-44. doi: 10.1093/annonc/mdm497. Epub 2008 Jan 22.

  PMID: 18212092 BACKGROUND

• Pfreundschuh M, Zwick C, Zeynalova S, Duhrsen U, Pfluger KH, Vrieling T, Mesters R, Mergenthaler HG, Einsele H, Bentz M, Lengfelder E, Trumper L, Rube C, Schmitz N, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL). Dose-escalated CHOEP for the treatment of young patients with aggressive non-Hodgkin's lymphoma: II. Results of the randomized high-CHOEP trial of the German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL). Ann Oncol. 2008 Mar;19(3):545-52. doi: 10.1093/annonc/mdm514. Epub 2007 Dec 6.

  PMID: 18065407 RESULT

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse; Burkitt Lymphoma; Lymphoma, Large-Cell, Immunoblastic; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Mantle-Cell

Interventions

Filgrastim; EPOCH protocol; Cyclophosphamide; Doxorubicin; Etoposide; Prednisone; Vincristine; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Therapeutics

Study Officials

• Michael G.M. Pfreundschuh, MD

  Universitaetsklinikum des Saarlandes

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2003
• First Posted: February 6, 2003
• Study Start: April 1, 2002
• Primary Completion: December 5, 2006
• Study Completion: December 5, 2006
• Last Updated: May 18, 2021

Record last verified: 2021-05

Locations

CH (2); DE (173)