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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Extragonadal Germ Cell Tumor Teratoma Testicular Germ Cell Tumor Biological: bleomycin sulfate Drug: cisplatin Drug: etoposide Drug: ifosfamide Drug: oxaliplatin Drug: paclitaxel Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
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
Official Title: A Risk-Adapted Strategy of the Use of Dose-Dense Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors
Actual Study Start Date : November 26, 2003
Actual Primary Completion Date : March 29, 2012
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00104676


Locations
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Sponsors and Collaborators
UNICANCER
Investigators
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Study Chair: Karim Fizazi, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT00104676    
Other Study ID Numbers: CDR0000416124
FRE-FNCLCC-GETUG-13/0206 ( Other Identifier: UNICANCER )
2005-001072-13 ( EudraCT Number )
First Posted: March 4, 2005    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
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.

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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
Keywords provided by UNICANCER:
stage II malignant testicular germ cell tumor
stage III malignant testicular germ cell tumor
testicular choriocarcinoma and embryonal carcinoma
testicular choriocarcinoma and teratoma
testicular choriocarcinoma and yolk sac tumor
testicular choriocarcinoma
testicular embryonal carcinoma and teratoma
testicular embryonal carcinoma and yolk sac tumor
 testicular embryonal carcinoma
testicular yolk sac tumor and teratoma
testicular yolk sac tumor
stage II extragonadal non-seminomatous germ cell tumor
stage III extragonadal non-seminomatous germ cell tumor
testicular immature teratoma
testicular mature teratoma
adult teratoma
Additional relevant MeSH terms:
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Neoplasms
Neoplasms, Germ Cell and Embryonal
Teratoma
Testicular Neoplasms
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Paclitaxel
Etoposide
Cisplatin
 Oxaliplatin
Ifosfamide
Bleomycin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Alkylating
Alkylating Agents
Antibiotics, Antineoplastic