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

NCT00104676 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: GETUG 13FRE-FNCLCC-GETUG-13/02062005-001072-13
• Study Type: interventional
• Target: 263
• Locations: 3 countries
• Sites: 24

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.

Conditions

Extragonadal Germ Cell Tumor; Teratoma; Testicular Germ Cell Tumor

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall Survival

  3 years from randomization

Study Arms (2)

Arm I

ACTIVE COMPARATOR

Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP).

Biological: bleomycin sulfate; Drug: cisplatin; Drug: etoposide

Arm II

EXPERIMENTAL

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; Drug: cisplatin; Drug: etoposide; Drug: ifosfamide; Drug: oxaliplatin; Drug: paclitaxel

Interventions

bleomycin sulfate BIOLOGICAL

At least one course administered

Arm I; Arm II

cisplatin DRUG

At least one course administered

Arm I; Arm II

etoposide DRUG

At least one course administered

Arm I; Arm II

ifosfamide DRUG

Given in a dose-dense sequential fashion

Arm II

oxaliplatin DRUG

Given in a dose-dense sequential fashion

Arm II

paclitaxel DRUG

Given in a dose-dense sequential fashion

Arm II

Eligibility Criteria

• Age: 16 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (24)

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Centre Paul Papin

Angers, 49100, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

C.H.U. de Brest

Brest, 29609, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

CHU de Grenoble - Hopital de la Tronche

Grenoble, 38043, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

Hopital Notre-Dame de Bon Secours

Metz, 57038, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Hopital Tenon

Paris, 75970, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Centre Hospitalier de Rodez

Rodez, 12027, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

CRLCC Nantes - Atlantique

Saint-Herblain, 44805, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Centre Hospitalier Universitaire Bretonneau de Tours

Tours, 37044, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

National Cancer Institute - Bratislava

Bratislava, 833 10, Slovakia

Location

Related Publications (2)

• 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.

  PMID: 39167741 DERIVED

• 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.

  PMID: 25456363 DERIVED

MeSH Terms

Conditions

Teratoma; Testicular Germ Cell Tumor; Testicular Neoplasms; Carcinoma, Embryonal; Endodermal Sinus Tumor

Interventions

Bleomycin; Cisplatin; Etoposide; Ifosfamide; Oxaliplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Mesonephroma

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Results Point of Contact

• Title: Deputy Director R&D
• Organization: Unicancer

b-juzyna@unicancer.fr

(+33)1 44 23 04 19

Study Officials

• Karim Fizazi, MD, PhD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase 3 trial with direct individual benefit, randomized, open-label, multicenter, parallel groups

Study Record Dates

• First Submitted: March 3, 2005
• First Posted: March 4, 2005
• Study Start: November 26, 2003
• Primary Completion: March 29, 2012
• Study Completion: February 8, 2023
• Last Updated: February 6, 2025
• Results First Posted: June 7, 2021

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); FR (22); SL (1)