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

Testicular Germ Cell Tumor Clinical Trial

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Extragonadal Germ Cell Tumor
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Teratoma
• Testicular Germ Cell Tumor
• Testicular Neoplasms

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