Combination Chemotherapy With or Without Peripheral Stem Cell Transplant in Treating Men With Previously Untreated Germ Cell Cancer
NCT ID: NCT00003941
Last Updated: 2012-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
222 participants
INTERVENTIONAL
1999-04-30
Brief Summary
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PURPOSE: This randomized phase III trial is studying how well combination chemotherapy works when given with peripheral stem cell transplant and how it compares with combination chemotherapy alone in treating men with previously untreated germ cell cancer.
Detailed Description
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* Compare the efficacy of standard cisplatin, etoposide, and ifosfamide (VIP) followed by sequential high-dose VIP and stem cell rescue versus bleomycin, etoposide, and cisplatin (BEP) in men with previously untreated poor-prognosis germ cell cancer.
* Compare the acute and late toxicities of these treatment regimens in this patient population.
* Compare these regimens in terms of failure-free survival, response rate, and overall survival in these patients.
* Evaluate the quality of life in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, primary mediastinal germ cell tumor (yes vs no), and nonpulmonary visceral metastases (liver vs bone vs brain). Patients are randomized to one of two treatment arms.
* Arm I: Patients receive etoposide IV over 1 hour followed by cisplatin IV over 1 hour on days 1-5 and bleomycin IV over 30 minutes on days 2, 8, and 15. Treatment repeats every 3 weeks for 4 courses.
* Arm II: Patients receive 1 course of standard dose chemotherapy consisting of etoposide IV over 1 hour followed by cisplatin IV over 1 hour and ifosfamide IV over 1 hour on days 1-5. Peripheral blood stem cells (PBSC) are harvested around day 12-15. Patients also receive daily filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until PBSC collection is complete.
After day 21, patients receive high-dose chemotherapy consisting of etoposide IV over 1 hour followed by cisplatin IV over 1 hour, and ifosfamide IV over 1 hour on days -6 through -2. PBSCs are infused on day 0. Patients receive daily G-CSF subcutaneously beginning on day 1 and continuing through day 19 or until blood counts have recovered. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed before chemotherapy, at 6 months, and at 2 years after treatment.
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 annually thereafter.
PROJECTED ACCRUAL: A total of 222 patients (111 per treatment arm) will be accrued for this study within 2 years.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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bleomycin sulfate
filgrastim
cisplatin
etoposide
ifosfamide
bone marrow ablation with stem cell support
peripheral blood stem cell transplantation
Eligibility Criteria
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Inclusion Criteria
* Histologically proven germ cell cancer
* Nonseminoma OR
* Combined seminoma and nonseminoma
* Poor prognosis (nonseminoma):
* Testis/retroperitoneal primary AND
* One of the following poor tumor markers
* AFP greater than 10,000 iu/L
* HCG greater than 50,000 iu/L
* LDH greater than 10 times upper limit of normal OR
* Nonpulmonary visceral metastases (i.e., liver, bone, or brain) OR
* Mediastinal primary
PATIENT CHARACTERISTICS:
Age:
* 16 to 50
Sex:
* Male
Performance status:
* WHO 0-3
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.25 times upper limit of normal (ULN)
* AST no greater than 2 times ULN
Renal:
* Creatinine clearance at least 60 mL/min (unless due to obstructive uropathy correctable by nephrostomy)
Other:
* No other malignancy except basal cell skin cancer
* No neuropathy
* No other serious illness or medical condition
* No psychological, familial, sociological, or geographical condition that would prevent compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* Concurrent radiotherapy for brain metastases allowed
Surgery:
* Concurrent surgery for brain metastases allowed
16 Years
50 Years
MALE
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Gedske Daugaard, MD, DMSc
Role: STUDY_CHAIR
Rigshospitalet, Denmark
Locations
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Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
Vienna (Wien), , Austria
Institut Jules Bordet
Brussels (Bruxelles), , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Aarhus University Hospital - Aarhus Sygehus - Norrebrogade
Aarhus, , Denmark
Rigshospitalet - Copenhagen University Hospital
Copenhagen, , Denmark
Universitaetsklinikum Bonn
Bonn, , Germany
Staedtisches Klinikum Dessau
Dessau, , Germany
St. Johannes Hospital - Medical Klinik II
Duisburg, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Staedtische Kliniken Frankfurt am Main - Hoechst
Frankfurt, , Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, , Germany
Universitaetsklinikum Halle
Halle, , Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Universitaetsklinikum des Saarlandes
Homburg, , Germany
Knappschaft Krankenhaus
Langendreer, , Germany
Johannes Gutenberg University
Mainz, , Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich (Muenchen), , Germany
Klinikum Nuernberg - Klinikum Nord
Nuremberg, , Germany
Klinikum der Universitaet Regensburg
Regensburg, , Germany
Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Leiden University Medical Center
Leiden, , Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, , Netherlands
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, , Netherlands
University Medical Center Rotterdam at Erasmus Medical Center
Rotterdam, , Netherlands
Norwegian Radium Hospital
Oslo, , Norway
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, , Poland
National Cancer Institute - Bratislava
Bratislava, , Slovakia
Hospital de la Santa Cruz i Sant Pau
Barcelona, , Spain
Institut Catala D'Oncologia
Barcelona, , Spain
Hospital Donostia
Donostia / San Sebastian, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario LA FE
Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
Inselspital Bern
Bern, , Switzerland
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom
Countries
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References
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Daugaard G, Skoneczna I, Aass N, De Wit R, De Santis M, Dumez H, Marreaud S, Collette L, Lluch JRG, Bokemeyer C, Schmoll HJ. A randomized phase III study comparing standard dose BEP with sequential high-dose cisplatin, etoposide, and ifosfamide (VIP) plus stem-cell support in males with poor-prognosis germ-cell cancer. An intergroup study of EORTC, GTCSG, and Grupo Germinal (EORTC 30974). Ann Oncol. 2011 May;22(5):1054-1061. doi: 10.1093/annonc/mdq575. Epub 2010 Nov 8.
Other Identifiers
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EORTC-30974
Identifier Type: -
Identifier Source: secondary_id
EORTC-30974
Identifier Type: -
Identifier Source: org_study_id