Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-30974 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 may kill more cancer cells. Peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy and kill more cancer cells. It is not yet known whether chemotherapy and peripheral stem cell transplant is more effective than chemotherapy alone.
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.
OBJECTIVES:
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bleomycin sulfate | Biological | |||
| filgrastim | Biological | |||
| cisplatin | Drug | |||
| etoposide | Drug | |||
| ifosfamide | Drug | |||
| bone marrow ablation with stem cell support | Procedure | |||
| peripheral blood stem cell transplantation | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Failure-free survival as measured by Logrank at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response as measured by negative tumor markers and no residual masses or viable cancer cells at the end of CT scan or debulking surgery | ||
| Overall survival as measured by Logrank at 2 years |
Not provided
DISEASE CHARACTERISTICS:
Histologically proven germ cell cancer
Poor prognosis (nonseminoma):
Testis/retroperitoneal primary AND
One of the following poor tumor markers
Nonpulmonary visceral metastases (i.e., liver, bone, or brain) OR
Mediastinal primary
PATIENT CHARACTERISTICS:
Age:
Sex:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gedske Daugaard, MD, DMSc | Rigshospitalet, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital | Vienna (Wien) | A-1100 | Austria | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21059637 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Quality of life as measured by Quality of Life Questionnaire-Core 30 (QLQ-C30) v3.0 at baseline, at month 6, and at year 2 |
| Toxicity as measured by NCI-CTC v2.0 after each course, every 6 months up to year 5, and yearly |
| Institut Jules Bordet |
| Brussels (Bruxelles) |
| 1000 |
| Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | B-2650 | Belgium |
| U.Z. Gasthuisberg | Leuven | B-3000 | Belgium |
| Aarhus University Hospital - Aarhus Sygehus - Norrebrogade | Aarhus | DK-8000 | Denmark |
| Rigshospitalet - Copenhagen University Hospital | Copenhagen | 2100 | Denmark |
| Universitaetsklinikum Bonn | Bonn | D-53105 | Germany |
| Staedtisches Klinikum Dessau | Dessau | D-06822 | Germany |
| St. Johannes Hospital - Medical Klinik II | Duisburg | D-47166 | Germany |
| Universitaetsklinikum Essen | Essen | D-45122 | Germany |
| Staedtische Kliniken Frankfurt am Main - Hoechst | Frankfurt | D-65929 | Germany |
| Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet | Greifswald | D-17487 | Germany |
| Universitaetsklinikum Halle | Halle | DOH-06112 | Germany |
| Universitaetsklinikum Hamburg-Eppendorf | Hamburg | D-20246 | Germany |
| Universitaetsklinikum des Saarlandes | Homburg | D-66421 | Germany |
| Knappschaft Krankenhaus | Langendreer | D-44892 | Germany |
| Johannes Gutenberg University | Mainz | D-55101 | Germany |
| Klinikum Rechts Der Isar - Technische Universitaet Muenchen | Munich (Muenchen) | D-81675 | Germany |
| Klinikum Nuernberg - Klinikum Nord | Nuremberg | D-90419 | Germany |
| Klinikum der Universitaet Regensburg | Regensburg | D-93053 | Germany |
| Ospedale di Circolo e Fondazione Macchi | Varese | 21100 | Italy |
| Leiden University Medical Center | Leiden | 2300 CA | Netherlands |
| Academisch Ziekenhuis Maastricht | Maastricht | 6202 AZ | Netherlands |
| Universitair Medisch Centrum St. Radboud - Nijmegen | Nijmegen | NL-6500 HB | Netherlands |
| University Medical Center Rotterdam at Erasmus Medical Center | Rotterdam | 3000 CA | Netherlands |
| Norwegian Radium Hospital | Oslo | N-0310 | Norway |
| Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | Warsaw | 02 781 | Poland |
| National Cancer Institute - Bratislava | Bratislava | 833 10 | Slovakia |
| Hospital de la Santa Cruz i Sant Pau | Barcelona | 08025 | Spain |
| Institut Catala D'Oncologia | Barcelona | 08907 | Spain |
| Hospital Donostia | Donostia / San Sebastian | 20014 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Universitario LA FE | Valencia | 46009 | Spain |
| Hospital Clinico Universitario Lozano Blesa | Zaragoza | 50009 | Spain |
| Inselspital Bern | Bern | CH-3010 | Switzerland |
| Leeds Cancer Centre at St. James's University Hospital | Leeds | England | LS9 7TF | United Kingdom |
| Velindre Cancer Center at Velindre Hospital | Cardiff | Wales | CF4 7XL | United Kingdom |
| ID | Term |
|---|---|
| D008479 | Mediastinal Neoplasms |
| D009362 | Neoplasm Metastasis |
| C563236 | Testicular Germ Cell Tumor |
| D013736 | Testicular Neoplasms |
| C562472 | Teratoma, Testicular |
| D018240 | Endodermal Sinus Tumor |
| D013724 | Teratoma |
| D018239 | Seminoma |
| D018236 | Carcinoma, Embryonal |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008477 | Mediastinal Diseases |
| D013896 | Thoracic Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004701 | Endocrine Gland Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
| D008649 | Mesonephroma |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D018237 | Germinoma |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001761 | Bleomycin |
| D000069585 | Filgrastim |
| D002945 | Cisplatin |
| D005047 | Etoposide |
| D007069 | Ifosfamide |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided