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

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ClinicalTrials.gov Identifier: NCT00104676
Recruitment Status : Active, not recruiting
First Posted : March 4, 2005
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
UNICANCER

Tracking Information
First Submitted Date  ICMJE March 3, 2005
First Posted Date  ICMJE March 4, 2005
Last Update Posted Date April 27, 2020
Actual Study Start Date  ICMJE November 26, 2003
Actual Primary Completion Date March 29, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2020)
  • Progression-free survival rate after 1 course of treatment [ Time Frame: 13 years ]
    Primary objective is to compare the progression-free survival of patients after un cycle of treatment, treated randomly by 3 additional cycles of BEP or by T-BEP-Oxaliplatin/cisplatin-ifosfamide-Bleomycin
  • Overall survival [ Time Frame: 13 years ]
    To evaluated the response rate, overall survival and toxicity in both groups in patients presented fast and slow decrease in serum levels of tumor markers
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors
Official Title  ICMJE A Risk-Adapted Strategy of the Use of Dose-Dense Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors
Brief 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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Phase 3 trial with direct individual benefit, randomized, open-label, multicenter, parallel groups
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Extragonadal Germ Cell Tumor
  • Teratoma
  • Testicular Germ Cell Tumor
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Arm I
    Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP).
    Interventions:
    • Biological: bleomycin sulfate
    • Drug: cisplatin
    • Drug: etoposide
  • 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.
    Interventions:
    • Biological: bleomycin sulfate
    • Drug: cisplatin
    • Drug: etoposide
    • Drug: ifosfamide
    • Drug: oxaliplatin
    • Drug: paclitaxel
Publications * Fizazi K, Pagliaro L, Laplanche A, Fléchon A, Mardiak J, Geoffrois L, Kerbrat P, Chevreau C, Delva R, Rolland F, Theodore C, Roubaud G, Gravis G, Eymard JC, Malhaire JP, Linassier C, Habibian M, Martin AL, Journeau F, Reckova M, Logothetis C, Culine S. Personalised chemotherapy based on tumour marker decline in poor prognosis germ-cell tumours (GETUG 13): a phase 3, multicentre, randomised trial. Lancet Oncol. 2014 Dec;15(13):1442-1450. doi: 10.1016/S1470-2045(14)70490-5. Epub 2014 Nov 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 7, 2009)
260
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE August 2022
Actual Primary Completion Date March 29, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 120 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Slovakia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00104676
Other Study ID Numbers  ICMJE CDR0000416124
FRE-FNCLCC-GETUG-13/0206 ( Other Identifier: UNICANCER )
2005-001072-13 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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.
Responsible Party UNICANCER
Study Sponsor  ICMJE UNICANCER
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Karim Fizazi, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris
PRS Account UNICANCER
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP