Combination Chemotherapy With or Without Peripheral Stem Cell Transplant in Treating Men With Previously Untreated Germ Cell Cancer

NCT00003941 | Completed Phase 3

• 1 other identifier: EORTC-30974
• Study Type: interventional
• Target: 222
• Locations: 12 countries
• Sites: 37

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 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.

Conditions

Mediastinal Cancer; Metastatic Cancer; Testicular Germ Cell Tumor

Keywords

stage III malignant testicular germ cell tumor; mediastinal cancer; testicular embryonal carcinoma; testicular choriocarcinoma; testicular teratoma; testicular yolk sac tumor; testicular embryonal carcinoma and teratoma; testicular embryonal carcinoma and teratoma with seminoma; testicular embryonal carcinoma and yolk sac tumor; testicular embryonal carcinoma and yolk sac tumor with seminoma; testicular embryonal carcinoma and seminoma; testicular yolk sac tumor and teratoma; testicular yolk sac tumor and teratoma with seminoma; testicular choriocarcinoma and yolk sac tumor; testicular choriocarcinoma and embryonal carcinoma; testicular choriocarcinoma and teratoma; testicular choriocarcinoma and seminoma; tumors metastatic to brain; liver metastases; bone metastases

Outcome Measures

Primary Outcomes (1)

• Failure-free survival as measured by Logrank at 1 year

Secondary Outcomes (4)

• 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

• 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

Interventions

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

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * 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

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

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (37)

Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital

Vienna (Wien), A-1100, Austria

Location

Institut Jules Bordet

Brussels (Bruxelles), 1000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Aarhus University Hospital - Aarhus Sygehus - Norrebrogade

Aarhus, DK-8000, Denmark

Location

Rigshospitalet - Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Universitaetsklinikum Bonn

Bonn, D-53105, Germany

Location

Staedtisches Klinikum Dessau

Dessau, D-06822, Germany

Location

St. Johannes Hospital - Medical Klinik II

Duisburg, D-47166, Germany

Location

Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

Staedtische Kliniken Frankfurt am Main - Hoechst

Frankfurt, D-65929, Germany

Location

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

Greifswald, D-17487, Germany

Location

Universitaetsklinikum Halle

Halle, DOH-06112, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, D-20246, Germany

Location

Universitaetsklinikum des Saarlandes

Homburg, D-66421, Germany

Location

Knappschaft Krankenhaus

Langendreer, D-44892, Germany

Location

Johannes Gutenberg University

Mainz, D-55101, Germany

Location

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich (Muenchen), D-81675, Germany

Location

Klinikum Nuernberg - Klinikum Nord

Nuremberg, D-90419, Germany

Location

Klinikum der Universitaet Regensburg

Regensburg, D-93053, Germany

Location

Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

University Medical Center Rotterdam at Erasmus Medical Center

Rotterdam, 3000 CA, Netherlands

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, 02 781, Poland

Location

National Cancer Institute - Bratislava

Bratislava, 833 10, Slovakia

Location

Hospital de la Santa Cruz i Sant Pau

Barcelona, 08025, Spain

Location

Institut Catala D'Oncologia

Barcelona, 08907, Spain

Location

Hospital Donostia

Donostia / San Sebastian, 20014, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Universitario LA FE

Valencia, 46009, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Inselspital Bern

Bern, CH-3010, Switzerland

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF4 7XL, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 21059637 RESULT

MeSH Terms

Conditions

Mediastinal Neoplasms; Neoplasm Metastasis; Testicular Germ Cell Tumor; Testicular Neoplasms; Teratoma, Testicular; Endodermal Sinus Tumor; Teratoma; Seminoma; Carcinoma, Embryonal; Brain Neoplasms

Interventions

Bleomycin; Filgrastim; Cisplatin; Etoposide; Ifosfamide; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Mediastinal Diseases; Thoracic Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Mesonephroma; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Germinoma; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Proteins; Biological Factors; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Gedske Daugaard, MD, DMSc

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: April 1, 1999
• Primary Completion: June 1, 2007
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

BE (3); SL (1); GB (2); IT (1); NO (1); ES (6); DE (14); AU (1); PL (1); DK (2); NL (4); CH (1)