Clinical trial · Interventional
Combination Chemotherapy in Treating Men With Germ Cell Cancer
Randomized Phase II/III Study of Taxol/Paclitaxel-BEP Versus BEP in Patients With Intermediate Prognosis Germ Cell Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy may be more effective for germ cell cancer. PURPOSE: This randomized phase II/III trial is studying two different regimens of combination chemotherapy and comparing how well they work in treating men with germ cell cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extragonadal Germ Cell Tumor | Extragonadal Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Teratoma | Teratoma | ONTOLOGY_EXACT | 0.90 |
| Testicular Germ Cell Tumor | Testicular Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bleomycin sulfate | Biological | Bleomycin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Failure-free survival as measured by Logrank
Secondary outcomes (5)
- measure
- Response to treatment as measured by normalized markers without residual viable cancer after CT scan or surgery
- measure
- Overall survival as measured by Logrank at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter
- measure
- Disease-free survival as measured by Logrank at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter
- measure
- Toxicity as measured by NCI-CTC v2.0 at end of each course, at 6 weeks after completion of study treatment, every 6 months up to year 5, and then annually thereafter
- measure
- Quality of life as measured by Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline, during treatment, and at years 1 and 2
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 16 Years
- Maximum age
- 50 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically proven germ cell cancer
* Seminoma
* Non-seminoma
* Combined
* Intermediate prognosis
* Non-seminoma:
* Testis/retroperitoneal primary
* No non-pulmonary visceral metastases
* Meets 1 of the following criteria:
* Alpha-fetoprotein (AFP) 1,000- 10,000 IU/L
* Human chorionic gonadotropin (hCG) 5,000-50,000 IU/L
* Lactic dehydrogenase (LDH) 1.5 times-10 times upper limit of normal (ULN)
* Seminoma:
* Any primary site
* Any LDH and HCG
* AFP normal
* Non-pulmonary visceral metastases present
PATIENT CHARACTERISTICS:
Age:
* 16 to 50
Sex:
* Male
Performance status:
* WHO 0-2
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.25 times ULN
* AST no greater than 2 times ULN
Renal:
* Creatinine clearance at least 40 mL/min (unless due to obstructive uropathy which can be relieved by nephrostomy)
Other:
* No pre-existing neuropathy
* No other malignancy except basal cell skin cancer
* No other serious illness or medical conditions incompatible with the protocol
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specifiedReferences
Publications (0)
Data not yet available