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

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Primary Purpose

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

bleomycin sulfate

cisplatin

etoposide

ifosfamide

oxaliplatin

paclitaxel

About this trial

This is an interventional treatment trial for Extragonadal Germ Cell Tumor focused on measuring 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

Eligibility Criteria

16 Years - 120 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

M. D. Anderson Cancer Center at University of Texas
Centre Paul Papin
Institut Bergonie
C.H.U. de Brest
Centre Regional Francois Baclesse
CHU de Grenoble - Hopital de la Tronche
Centre Oscar Lambret
Centre Leon Berard
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Hopital Notre-Dame de Bon Secours
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Centre Antoine Lacassagne
Hopital Europeen Georges Pompidou
Hopital Tenon
Institut Jean Godinot
Centre Eugene Marquis
Centre Hospitalier de Rodez
Centre Henri Becquerel
CRLCC Nantes - Atlantique
Institut Claudius Regaud
Centre Hospitalier Universitaire Bretonneau de Tours
Centre Alexis Vautrin
Institut Gustave Roussy
National Cancer Institute - Bratislava

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I

Arm II

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00104676

First Posted

March 3, 2005

Last Updated

August 31, 2023

Sponsor

UNICANCER

1. Study Identification

Unique Protocol Identification Number

NCT00104676

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 26, 2003 (Actual)

Primary Completion Date

March 29, 2012 (Actual)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UNICANCER

4. Oversight

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

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

263 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm II

Arm Type

Experimental

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

bleomycin sulfate

Intervention Description

At least one course administered

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Description

At least one course administered

Intervention Type

Drug

Intervention Name(s)

etoposide

Intervention Description

At least one course administered

Intervention Type

Drug

Intervention Name(s)

ifosfamide

Intervention Description

Given in a dose-dense sequential fashion

Intervention Type

Drug

Intervention Name(s)

oxaliplatin

Intervention Description

Given in a dose-dense sequential fashion

Intervention Type

Drug

Intervention Name(s)

paclitaxel

Intervention Description

Given in a dose-dense sequential fashion

Primary Outcome Measure Information:

Title

Progression-free Survival Rate After 1 Course of Treatment

Description

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.

Time Frame

3 years from randomization

Secondary Outcome Measure Information:

Title

Overall Survival

Description

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.

Time Frame

3 years from randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karim Fizazi, MD, PhD

Organizational Affiliation

Gustave Roussy, Cancer Campus, Grand Paris

Official's Role

Study Chair

Facility Information:

Facility Name

M. D. Anderson Cancer Center at University of Texas

City

Houston

State/Province

Texas

ZIP/Postal Code

77030-4009

Country

United States

Facility Name

Centre Paul Papin

City

Angers

ZIP/Postal Code

49100

Country

France

Facility Name

Institut Bergonie

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

C.H.U. de Brest

City

Brest

ZIP/Postal Code

29609

Country

France

Facility Name

Centre Regional Francois Baclesse

City

Caen

ZIP/Postal Code

14076

Country

France

Facility Name

CHU de Grenoble - Hopital de la Tronche

City

Grenoble

ZIP/Postal Code

38043

Country

France

Facility Name

Centre Oscar Lambret

City

Lille

ZIP/Postal Code

59020

Country

France

Facility Name

Centre Leon Berard

City

Lyon

ZIP/Postal Code

69008

Country

France

Facility Name

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

City

Marseille

ZIP/Postal Code

13273

Country

France

Facility Name

Hopital Notre-Dame de Bon Secours

City

Metz

ZIP/Postal Code

57038

Country

France

Facility Name

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

City

Montpellier

ZIP/Postal Code

34298

Country

France

Facility Name

Centre Antoine Lacassagne

City

Nice

ZIP/Postal Code

06189

Country

France

Facility Name

Hopital Europeen Georges Pompidou

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Hopital Tenon

City

Paris

ZIP/Postal Code

75970

Country

France

Facility Name

Institut Jean Godinot

City

Reims

ZIP/Postal Code

51056

Country

France

Facility Name

Centre Eugene Marquis

City

Rennes

ZIP/Postal Code

35042

Country

France

Facility Name

Centre Hospitalier de Rodez

City

Rodez

ZIP/Postal Code

12027

Country

France

Facility Name

Centre Henri Becquerel

City

Rouen

ZIP/Postal Code

76038

Country

France

Facility Name

CRLCC Nantes - Atlantique

City

Saint-Herblain

ZIP/Postal Code

44805

Country

France

Facility Name

Institut Claudius Regaud

City

Toulouse

ZIP/Postal Code

31052

Country

France

Facility Name

Centre Hospitalier Universitaire Bretonneau de Tours

City

Tours

ZIP/Postal Code

37044

Country

France

Facility Name

Centre Alexis Vautrin

City

Vandoeuvre-les-Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

Institut Gustave Roussy

City

Villejuif

ZIP/Postal Code

F-94805

Country

France

Facility Name

National Cancer Institute - Bratislava

City

Bratislava

ZIP/Postal Code

833 10

Country

Slovakia

12. IPD Sharing Statement

Plan to Share IPD

No

IPD Sharing 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.

Citations:

PubMed Identifier

25456363

Citation

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.

Results Reference

derived

Extragonadal Germ Cell Tumor, Teratoma, Testicular Germ Cell Tumor

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial