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

February 1, 2024 updated by: UNICANCER

A Risk-Adapted Strategy of the Use of Dose-Dense Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

263

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49100
        • Centre Paul Papin
      • Bordeaux, France, 33076
        • Institut Bergonié
      • Brest, France, 29609
        • C.H.U. de Brest
      • Caen, France, 14076
        • Centre Regional Francois Baclesse
      • Grenoble, France, 38043
        • CHU de Grenoble - Hopital de la Tronche
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lyon, France, 69008
        • Centre Leon Berard
      • Marseille, France, 13273
        • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
      • Metz, France, 57038
        • Hopital Notre-Dame de Bon Secours
      • Montpellier, France, 34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Paris, France, 75015
        • Hopital Europeen Georges Pompidou
      • Paris, France, 75970
        • Hopital Tenon
      • Reims, France, 51056
        • Institut Jean Godinot
      • Rennes, France, 35042
        • Centre Eugene Marquis
      • Rodez, France, 12027
        • Centre Hospitalier de Rodez
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Saint-Herblain, France, 44805
        • CRLCC Nantes - Atlantique
      • Toulouse, France, 31052
        • Institut Claudius Regaud
      • Tours, France, 37044
        • Centre Hospitalier Universitaire Bretonneau de Tours
      • Vandoeuvre-les-Nancy, France, 54511
        • Centre Alexis Vautrin
      • Villejuif, France, F-94805
        • Institut Gustave Roussy
  • Slovakia
      • Bratislava, Slovakia, 833 10
        • National Cancer Institute - Bratislava
  • United States
    • Texas
      • Houston, Texas, United States, 77030-4009
        • M. D. Anderson Cancer Center at University of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I
Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP).
Biological: bleomycin sulfate
At least one course administered
Drug: cisplatin
At least one course administered
Drug: etoposide
At least one course administered
Experimental: Arm II
Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide.
Biological: bleomycin sulfate
At least one course administered
Drug: cisplatin
At least one course administered
Drug: etoposide
At least one course administered
Drug: ifosfamide
Given in a dose-dense sequential fashion
Drug: oxaliplatin
Given in a dose-dense sequential fashion
Drug: paclitaxel
Given in a dose-dense sequential fashion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival Rate After 1 Course of Treatment
Time Frame: 3 years from randomization
Primary objective is to compare the progression-free survival of participants after 1 cycle of treatment, treated randomly by 3 additional cycles of BEP (Arm I) or by T-BEP-Oxaliplatin/cisplatin-ifosfamide-Bleomycin (Arm II). The median progression-free survival rate was defined as the median percentage of participants alive without disease progression after 1 course of treatment.
3 years from randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 3 years from randomization
To evaluated the overall survival in both groups in participants presenting fast and slow decrease in serum levels of tumor markers. The median overall survival was defined as the median percentage of participants alive after 1 course of treatment.
3 years from randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Investigators

  • Study Chair: Karim Fizazi, MD, PhD, Gustave Roussy, Cancer Campus, Grand Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2003

Primary Completion (Actual)

March 29, 2012

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 3, 2005

First Submitted That Met QC Criteria

March 3, 2005

First Posted (Estimated)

March 4, 2005

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GETUG 13
  • FRE-FNCLCC-GETUG-13/0206 (Other Identifier: UNICANCER)
  • 2005-001072-13 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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