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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00104676
Other study ID # GETUG 13
Secondary ID FRE-FNCLCC-GETUG
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date November 26, 2003
Est. completion date December 2024

Study information

Verified date February 2024
Source UNICANCER
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 263
Est. completion date December 2024
Est. primary completion date March 29, 2012
Accepts healthy volunteers No
Gender All
Age group 16 Years to 120 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Biological:
bleomycin sulfate
At least one course administered
Drug:
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

Locations

Country Name City State
France 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 Vandoeuvre-les-Nancy
France Institut Gustave Roussy Villejuif
Slovakia National Cancer Institute - Bratislava Bratislava
United States M. D. Anderson Cancer Center at University of Texas Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
UNICANCER

Countries where clinical trial is conducted

United States,  France,  Slovakia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free Survival Rate After 1 Course of Treatment 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 Overall Survival 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
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