Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors
NCT ID: NCT00104676
Last Updated: 2025-02-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
263 participants
INTERVENTIONAL
2003-11-26
2023-02-08
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I
Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP).
bleomycin sulfate
At least one course administered
cisplatin
At least one course administered
etoposide
At least one course administered
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.
bleomycin sulfate
At least one course administered
cisplatin
At least one course administered
etoposide
At least one course administered
ifosfamide
Given in a dose-dense sequential fashion
oxaliplatin
Given in a dose-dense sequential fashion
paclitaxel
Given in a dose-dense sequential fashion
Interventions
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bleomycin sulfate
At least one course administered
cisplatin
At least one course administered
etoposide
At least one course administered
ifosfamide
Given in a dose-dense sequential fashion
oxaliplatin
Given in a dose-dense sequential fashion
paclitaxel
Given in a dose-dense sequential fashion
Eligibility Criteria
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Inclusion Criteria
* 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
16 Years
120 Years
ALL
No
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Karim Fizazi, MD, PhD
Role: STUDY_CHAIR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Centre Paul Papin
Angers, , France
Institut Bergonie
Bordeaux, , France
C.H.U. de Brest
Brest, , France
Centre Regional Francois Baclesse
Caen, , France
CHU de Grenoble - Hopital de la Tronche
Grenoble, , France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, , France
Hopital Notre-Dame de Bon Secours
Metz, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
Centre Antoine Lacassagne
Nice, , France
Hopital Europeen Georges Pompidou
Paris, , France
Hopital Tenon
Paris, , France
Institut Jean Godinot
Reims, , France
Centre Eugene Marquis
Rennes, , France
Centre Hospitalier de Rodez
Rodez, , France
Centre Henri Becquerel
Rouen, , France
CRLCC Nantes - Atlantique
Saint-Herblain, , France
Institut Claudius Regaud
Toulouse, , France
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
National Cancer Institute - Bratislava
Bratislava, , Slovakia
Countries
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References
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Fizazi K, Le Teuff G, Flechon A, Pagliaro L, Mardiak J, Geoffrois L, Laguerre B, Chevreau C, Delva R, Rolland F, Theodore C, Roubaud G, Gravis G, Eymard JC, Cancel M, Juzyna B, Reckova M, Naoun N, Logothetis C, Culine S. Personalized Chemotherapy on the Basis of Tumor Marker Decline in Poor-Prognosis Germ-Cell Tumors: Updated Analysis of the GETUG-13 Phase III Trial. J Clin Oncol. 2024 Oct;42(28):3270-3276. doi: 10.1200/JCO.23.01960. Epub 2024 Aug 21.
Fizazi K, Pagliaro L, Laplanche A, Flechon 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.
Other Identifiers
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FRE-FNCLCC-GETUG-13/0206
Identifier Type: OTHER
Identifier Source: secondary_id
2005-001072-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GETUG 13
Identifier Type: -
Identifier Source: org_study_id
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