Clinical trial · Interventional
Combination Chemotherapy in Treating Male Patients With Germ Cell Tumors
Randomized Phase II Trial of Intensive Induction Chemotherapy (CBOP/BEP) and Standard BEP Chemotherapy in Poor Prognosis Male Germ Cell Tumors
- 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, such as cisplatin, vincristine, bleomycin, carboplatin, and etoposide phosphate, 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. It is not yet known which combination chemotherapy regimen is more effective in treating germ cell tumors. PURPOSE: This randomized phase II trial is studying two different combination chemotherapy regimens to compare how well they work in treating male patients with germ cell tumors.
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 |
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| etoposide phosphate | Drug | Etoposide | ALIAS |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rates to treatment
Secondary outcomes (3)
- measure
- Overall survival
- measure
- Progression-free survival
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Nonseminoma germ cell tumor of any extracranial primary site diagnosed by 1 of the following methods: * Histologic confirmation * Alpha-fetoprotein (AFP) \> 1,000 ng/mL or human chorionic gonadotropin (hCG) \> 5,000 IU/L with appropriate clinical picture in a man \< 45 years of age * Poor prognosis features as defined by ≥ 1 of the following: * AFP \> 10,000 ng/mL * hCG \> 50,000 IU/L * Lactic dehydrogenase \> 10 times normal * Nonpulmonary visceral metastases * Mediastinal primary site PATIENT CHARACTERISTICS: * Male * WHO performance status 0-3 * Glomerular filtration rate \> 50 mL/min * Less than 50 mL/min eligible if due to obstructive neuropathy that can be relieved by stenting or nephrostomy * No comorbid condition that would prevent treatment * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * No prior chemotherapy except low-dose chemotherapy to stabilize disease before study therapy
References
Publications (1)
- RESULTHuddart RA, Gabe R, Cafferty FH, Pollock P, White JD, Shamash J, Cullen MH, Stenning SP; TE23 Trial Management Group and Collaborators; National Cancer Research Institute Testis Cancer Clinical Studies Group. A randomised phase 2 trial of intensive induction chemotherapy (CBOP/BEP) and standard BEP in poor-prognosis germ cell tumours (MRC TE23, CRUK 05/014, ISRCTN 53643604). Eur Urol. 2015 Mar;67(3):534-43. doi: 10.1016/j.eururo.2014.06.034. Epub 2014 Jul 4. PMID 25001888