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Mediastinal CancerPhase 3NCT00003941

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

A Phase 3 study testing bleomycin sulfate, filgrastim and cisplatin in people with Mediastinal Cancer and Metastatic Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 37 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 50 years, men only
What is being tested?
bleomycin sulfate, filgrastim and cisplatin
Type of treatment
Surgery or procedure
How many people
222 participants
Where
37 sitesin 12 countries
Study dates
Apr 1999to Jun 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 50 years
  • Men only
  • No healthy volunteers
  • Child, Adult

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

Trial locations and contacts

37 sites in 12 countries.

37 sites in 12 countries

Germany14 sites

  • Universitaetsklinikum Bonn

    Bonn, D-53105

  • Staedtisches Klinikum Dessau

    Dessau, D-06822

  • St. Johannes Hospital - Medical Klinik II

    Duisburg, D-47166

  • Universitaetsklinikum Essen

    Essen, D-45122

  • Staedtische Kliniken Frankfurt am Main - Hoechst

    Frankfurt, D-65929

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

    Greifswald, D-17487

  • Universitaetsklinikum Halle

    Halle, DOH-06112

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, D-20246

  • Universitaetsklinikum des Saarlandes

    Homburg, D-66421

  • Knappschaft Krankenhaus

    Langendreer, D-44892

  • Johannes Gutenberg University

    Mainz, D-55101

  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen

    Munich (Muenchen), D-81675

  • Klinikum Nuernberg - Klinikum Nord

    Nuremberg, D-90419

  • Klinikum der Universitaet Regensburg

    Regensburg, D-93053

Other trials in Germany

Spain6 sites

  • Hospital de la Santa Cruz i Sant Pau

    Barcelona, 08025

  • Institut Catala D'Oncologia

    Barcelona, 08907

  • Hospital Donostia

    Donostia / San Sebastian, 20014

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitario LA FE

    Valencia, 46009

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Netherlands4 sites

  • Leiden University Medical Center

    Leiden, 2300 CA

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6202 AZ

  • Universitair Medisch Centrum St. Radboud - Nijmegen

    Nijmegen, NL-6500 HB

  • University Medical Center Rotterdam at Erasmus Medical Center

    Rotterdam, 3000 CA

Other trials in Netherlands

Belgium3 sites

  • Institut Jules Bordet

    Brussels (Bruxelles), 1000

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • U.Z. Gasthuisberg

    Leuven, B-3000

Other trials in Belgium

Denmark2 sites

  • Aarhus University Hospital - Aarhus Sygehus - Norrebrogade

    Aarhus, DK-8000

  • Rigshospitalet - Copenhagen University Hospital

    Copenhagen, 2100

Other trials in Denmark

United Kingdom2 sites

  • Velindre Cancer Center at Velindre Hospital

    Cardiff, Wales, CF4 7XL

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England, LS9 7TF

Other trials in United Kingdom

Austria1 site

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

    Vienna (Wien), A-1100

Other trials in Austria

Italy1 site

  • Ospedale di Circolo e Fondazione Macchi

    Varese, 21100

Other trials in Italy

Norway1 site

  • Norwegian Radium Hospital

    Oslo, N-0310

Other trials in Norway

Poland1 site

  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

    Warsaw, 02 781

Other trials in Poland

Slovakia1 site

  • National Cancer Institute - Bratislava

    Bratislava, 833 10

Other trials in Slovakia

Switzerland1 site

  • Inselspital Bern

    Bern, CH-3010

Other trials in Switzerland

About this study

Official title: A Randomized Phase III Study of Sequential High-Dose Cisplatinum/Etoposide/Ifosfamide Plus Stem Cell Support Versus BEP in Patients With Poor Prognosis Germ Cell Cancer

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.

Read the detailed description

OBJECTIVES:

  • 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.

Being tested
bleomycin sulfate, filgrastim, cisplatin, etoposide, ifosfamide
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
Medical subject headings
Mediastinal Neoplasms, Neoplasm Metastasis, Testicular Germ Cell Tumor, Testicular Neoplasms, Teratoma, Testicular, Endodermal Sinus Tumor, Teratoma, Seminoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

  1. 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

  2. Overall survival as measured by Logrank at 2 years

  3. 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

  4. Toxicity as measured by NCI-CTC v2.0 after each course, every 6 months up to year 5, and yearly

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startApr 1999
  3. Primary completionJun 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
222 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003941
Sponsor's protocol ID
EORTC-30974
Other IDs
EORTC-30974
Status last verified
Sep 2012
First submitted
1 Nov 1999
Last updated
24 Sep 2012
Results posted
No

Publications

  • 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.

    PubMed 21059637

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bleomycin sulfate, filgrastim and cisplatin in people with Mediastinal Cancer and Metastatic Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 37 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Germany, Spain, Netherlands, Belgium, Denmark and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Failure-free survival as measured by Logrank at 1 year. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003941, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2012.

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