A Phase 3 interventional study of bleomycin sulfate and cisplatin in Extragonadal Germ Cell Tumor, Teratoma and Testicular Germ Cell Tumor, sponsored by UNICANCER. Completed at 24 sites in 3 countries. Open to participants aged 16 Years to 120 Years. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by UNICANCER · Phase 3, Interventional, and Treatment
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.
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 263 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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DISEASE CHARACTERISTICS:
Diagnosis of non-seminomatous germ cell tumors (NSGCT) as evidenced by 1 of the following criteria:
Poor prognosis disease, meeting 1 of the following criteria:
One of the following lab values:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP).
Biological: bleomycin sulfate · Drug: cisplatin · Drug: etoposide
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
At least one course administered
At least one course administered
At least one course administered
Given in a dose-dense sequential fashion
Given in a dose-dense sequential fashion
Given in a dose-dense sequential fashion
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.
Time frame: 3 years from randomization
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.
Time frame: 3 years from randomization
| Milestone | Arm I | Arm II |
|---|---|---|
| Started | 98 | 105 |
| Completed | 91 | 91 |
| Not completed | 7 | 14 |
| Withdrew: Death | 3 | 2 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Treatment interruption | 4 | 10 |
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.
| percentage of participants | Arm I | Arm II |
|---|---|---|
| Progression-free Survival Rate After 1 Course of Treatment | 48 (38 to 59) | 59 (49 to 68) |
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.
| percentage of participants | Arm I | Arm II |
|---|---|---|
| Overall Survival | 65 (55 to 75) | 73 (64 to 81) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I | 61/98 (62.2%) | 37/98 (37.8%) | 98/98 (100%) |
| Arm II | 66/105 (62.9%) | 58/105 (55.2%) | 105/105 (100%) |
| Event | Arm I | Arm II |
|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 26/98 | 17/105 |
| Febrile neutropeniaBlood and lymphatic system disorders | 5/98 | 9/105 |
| AnemiaBlood and lymphatic system disorders | 5/98 | 7/105 |
| ThrombopeniaBlood and lymphatic system disorders | 1/98 | 7/105 |
| InfectionInfections and infestations | 1/98 | 6/105 |
| SeizureNervous system disorders | 2/98 | 6/105 |
| Febrile aplasiaBlood and lymphatic system disorders | 1/98 | 5/105 |
| FeverGeneral disorders | 3/98 | 5/105 |
| SepsisInfections and infestations | 2/98 | 5/105 |
| NeuropathyNervous system disorders | 0/98 | 5/105 |
| Event | Arm I | Arm II |
|---|---|---|
| HemoglobinBlood and lymphatic system disorders | 98/98 | 105/105 |
| NauseaGastrointestinal disorders | 72/98 | 91/105 |
| AstheniaGeneral disorders | 76/98 | 90/105 |
| PlateletsBlood and lymphatic system disorders | 72/98 | 88/105 |
| GranulocytesBlood and lymphatic system disorders | 79/98 | 84/105 |
| NeuropathyNervous system disorders | 21/98 | 82/105 |
| DiarrheaGastrointestinal disorders | 20/98 | 52/105 |
| Auditory disorderEar and labyrinth disorders | 28/98 | 52/105 |
| Liver function test increasedHepatobiliary disorders | 43/98 | 36/105 |
| MucositisGastrointestinal disorders | 18/98 | 45/105 |
| Age, Continuous(Years) | Arm I | Arm II | Total |
|---|---|---|---|
| Median | 27 (17 to 65) | 30 (16 to 51) | 30 (16 to 65) |
| Sex: Female, Male(Participants) | Arm I | Arm II | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 98 | 105 | 203 |
| Region of Enrollment(participants) | Arm I | Arm II | Total |
|---|---|---|---|
| United States | 10 | 9 | 19 |
| Slovakia | 9 | 9 | 18 |
| France | 79 | 87 | 166 |
Plan to share: No — Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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