Combination Chemotherapy in Treating Men With Germ Cell Cancer
- Conditions
- Extragonadal Germ Cell TumorTeratomaTesticular Germ Cell Tumor
- Registration Number
- NCT00003643
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy may be more effective for germ cell cancer.
PURPOSE: This randomized phase II/III trial is studying two different regimens of combination chemotherapy and comparing how well they work in treating men with germ cell cancer.
- Detailed Description
OBJECTIVES:
Phase II
* Compare the complete response rates in men with intermediate prognosis germ cell cancer treated with bleomycin, cisplatin, and etoposide (BEP) vs bleomycin, cisplatin, etoposide, and paclitaxel (T-BEP).
* Define the toxicity profile of T-BEP in these patients.
Phase III
* Compare the disease-free survival of patients treated with these regimens.
* Compare the complete response rates and overall survival of patients treated with these regimens.
* Compare symptoms and aspects of quality of life at baseline and after treatment in patients treated with these regimens.
* Compare the acute and intermediate (1-2 years) side effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to histology (seminoma vs non-seminoma) and hospital. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive cisplatin IV and etoposide IV on days 1-5 and bleomycin IV on days 1, 8, and 15.
* Arm II: Patients receive cisplatin, etoposide, and bleomycin as in arm I and paclitaxel IV over 3 hours on day 1. Patients also receive filgrastim (G-CSF) subcutaneously on days 6-15.
In both arms, treatment repeats every 3 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed before treatment randomization and at 1 and 2 years after randomization.
Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 84-164 patients (42-82 per treatment arm) will be accrued for the phase II study. A total of 498 patients (249 per treatment arm) will be accrued for the phase III study. Accrual will be completed within 4 years.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 498
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Failure-free survival as measured by Logrank
- Secondary Outcome Measures
Name Time Method Response to treatment as measured by normalized markers without residual viable cancer after CT scan or surgery Overall survival as measured by Logrank at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter Disease-free survival as measured by Logrank at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter Toxicity as measured by NCI-CTC v2.0 at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter Quality of life as measured by Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline, during treatment, and at years 1 and 2
Trial Locations
- Locations (69)
Klinikum der Stadt Mannheim
🇩🇪Mannheim, Germany
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Aarhus Universitetshospital - Aarhus Sygehus
🇩🇰Aarhus, Denmark
Centre Regional Francois Baclesse
🇫🇷Caen, France
Ospedale di Circolo e Fondazione Macchi
🇮🇹Varese, Italy
Klinikum der Universitaet Regensburg
🇩🇪Regensburg, Germany
University Medical Center Hamburg - Eppendorf
🇩🇪Hamburg, Germany
Hospital de la Santa Cruz i Sant Pau
🇪🇸Barcelona, Spain
Vall d'Hebron University Hospital
🇪🇸Barcelona, Spain
Universitaetsklinikum Halle
🇩🇪Halle, Germany
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
🇩🇪Berlin, Germany
Klinikum der Stadt Ludwigshafen am Rhein
🇩🇪Ludwigshafen am Rhein, Germany
Institut Gustave Roussy
🇫🇷Villejuif, France
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
🇩🇪Greifswald, Germany
Institut Claudius Regaud
🇫🇷Toulouse, France
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Allgemeines Krankenhaus Hagen
🇩🇪Hagen, Germany
Universitaetsklinikum Bonn
🇩🇪Bonn, Germany
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Klinikum Kassel
🇩🇪Kassel, Germany
Hospital Universitario San Carlos
🇪🇸Madrid, Spain
Universitair Medisch Centrum St. Radboud - Nijmegen
🇳🇱Nijmegen, Netherlands
Hospital Clinico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Institut Catala D'Oncologia
🇪🇸Barcelona, Spain
Christie Hospital
🇬🇧Manchester, England, United Kingdom
Rigshospitalet - Copenhagen University Hospital
🇩🇰Copenhagen, Denmark
Universitaetsklinikum Giessen und Marburg GmbH - Marburg
🇩🇪Marburg, Germany
Klinikum Nuernberg - Klinikum Nord
🇩🇪Nuremberg, Germany
Southwest German Cancer Center at Eberhard-Karls-University
🇩🇪Tuebingen, Germany
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, Spain
Hospital Universitario La Fe
🇪🇸Valencia, Spain
Hospital Sant Joan de Reus
🇪🇸Reus, Spain
St. Johannes Hospital - Medical Klinik II
🇩🇪Duisburg, Germany
Universitaetsklinikum des Saarlandes
🇩🇪Homburg, Germany
Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
🇩🇪Muenster, Germany
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
🇩🇪Magdeburg, Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
🇩🇪Munich, Germany
Klinikum Schwerin
🇩🇪Schwerin, Germany
Assaf Harofeh Medical Center
🇮🇱Zerifin, Israel
National Institute of Oncology
ðŸ‡ðŸ‡ºBudapest, Hungary
Jeroen Bosch Ziekenhuis
🇳🇱's-Hertogenbosch, Netherlands
Daniel Den Hoed Cancer Center at Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
National Cancer Institute - Bratislava
🇸🇰Bratislava, Slovakia
Hospital Universidad Virgen Del Rocio
🇪🇸Sevilla, Spain
University College Hospital - London
🇬🇧London, England, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Royal South Hants Hospital
🇬🇧Southampton, England, United Kingdom
Norwegian Radium Hospital
🇳🇴Oslo, Norway
University Medical Center Rotterdam at Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
🇵🇱Warsaw, Poland
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Rosemere Cancer Centre at Royal Preston Hospital
🇬🇧Preston, England, United Kingdom
Berkshire Cancer Centre at Royal Berkshire Hospital
🇬🇧Reading, England, United Kingdom
Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
🇦🇹Vienna, Austria
Academisch Medisch Centrum at University of Amsterdam
🇳🇱Amsterdam, Netherlands
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Institut Jules Bordet
🇧🇪Brussels, Belgium
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital
🇬🇧Cheltenham, England, United Kingdom
Western Infirmary
🇬🇧Glasgow, Scotland, United Kingdom
Gartnavel General Hospital
🇬🇧Glasgow, Scotland, United Kingdom
Southend University Hospital NHS Foundation Trust
🇬🇧Westcliff-On-Sea, England, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, United Kingdom
Velindre Cancer Center at Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands