Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors

Last updated: January 22, 2025
Sponsor: UNICANCER
Overall Status: Completed

Phase

3

Condition

Germ Cell Tumors

Urologic Cancer

Testicular Cancer

Treatment

cisplatin

bleomycin sulfate

paclitaxel

Clinical Study ID

NCT00104676
GETUG 13
2005-001072-13
FRE-FNCLCC-GETUG-13/0206
  • Ages 16-120
  • All Genders

Study Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III non-seminomatous germ cell tumors.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS:

  • Diagnosis of non-seminomatous germ cell tumors (NSGCT) as evidenced by 1 of the following criteria:

  • Histologically confirmed NSGCT

  • Clinical evidence of disease AND high serum human chorionic gonadotropin (HCG) or alpha-fetoprotein (AFP) levels

  • Clinical stage II-III disease (disseminated disease)

  • Testicular, retroperitoneal, or mediastinal primary site

  • Poor prognosis disease, meeting 1 of the following criteria:

  • Mediastinal primary site

  • Non-pulmonary visceral metastases

  • One of the following lab values:

  • HCG > 50,000 UI/L

  • AFP > 10,000 ng/mL

  • Lactate dehydrogenase > 10 times upper limit of normal (ULN)

PATIENT CHARACTERISTICS:

Age

  • Over 16

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Absolute granulocyte count ≥ 1,500/mm^3

  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times ULN

Renal

  • Creatinine clearance > 60 mL/min

Other

  • No other prior malignancy except basal cell skin cancer

  • No HIV positivity

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Study Design

Total Participants: 263
Treatment Group(s): 6
Primary Treatment: cisplatin
Phase: 3
Study Start date:
November 26, 2003
Estimated Completion Date:
February 08, 2023

Study Description

OBJECTIVES:

  • Compare progression-free survival rates of patients with poor prognosis stage II or III non-seminomatous germ cell tumors with an unfavorable decrease of tumor markers after treatment with 1 course of bleomycin, etoposide, and cisplatin followed by subsequent treatment with 3 additional courses of bleomycin, etoposide, and cisplatin OR dose-dense sequential combination chemotherapy.

  • Compare overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study.

Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients with a favorable decrease of tumor markers after 1 course of BEP receive 3 additional courses of BEP. Patients with an unfavorable decrease of tumor markers after 1 course of BEP are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive 3 additional courses of BEP.

  • Arm II: Patients receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide.

PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study.

Connect with a study center

  • Centre Paul Papin

    Angers, 49100
    France

    Site Not Available

  • Institut Bergonie

    Bordeaux, 33076
    France

    Site Not Available

  • C.H.U. de Brest

    Brest, 29609
    France

    Site Not Available

  • Centre Regional Francois Baclesse

    Caen, 14076
    France

    Site Not Available

  • CHU de Grenoble - Hopital de la Tronche

    Grenoble, 38043
    France

    Site Not Available

  • Centre Oscar Lambret

    Lille, 59020
    France

    Site Not Available

  • Centre Leon Berard

    Lyon, 69008
    France

    Site Not Available

  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

    Marseille, 13273
    France

    Site Not Available

  • Hopital Notre-Dame de Bon Secours

    Metz, 57038
    France

    Site Not Available

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298
    France

    Site Not Available

  • CRLCC Nantes - Atlantique

    Nantes-Saint Herblain, 44805
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice, 06189
    France

    Site Not Available

  • Hopital Europeen Georges Pompidou

    Paris, 75015
    France

    Site Not Available

  • Hopital Tenon

    Paris, 75970
    France

    Site Not Available

  • Institut Jean Godinot

    Reims, 51056
    France

    Site Not Available

  • Centre Eugene Marquis

    Rennes, 35042
    France

    Site Not Available

  • Centre Hospitalier de Rodez

    Rodez, 12027
    France

    Site Not Available

  • Centre Henri Becquerel

    Rouen, 76038
    France

    Site Not Available

  • CRLCC Nantes - Atlantique

    Saint-Herblain, 44805
    France

    Site Not Available

  • Institut Claudius Regaud

    Toulouse, 31052
    France

    Site Not Available

  • Centre Hospitalier Universitaire Bretonneau de Tours

    Tours, 37044
    France

    Site Not Available

  • Centre Alexis Vautrin

    Vandoeuvre-les-Nancy, 54511
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif, F-94805
    France

    Site Not Available

  • National Cancer Institute - Bratislava

    Bratislava, 833 10
    Slovakia

    Site Not Available

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas 77030-4009
    United States

    Site Not Available

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