Randomized phase III trial of 1 course BEP (Bleomycin, Etoposid, Cisplatin) versus 2 courses BEP adjuvant chemotherapy in patients with high-risk non-seminomatous germ cell tumors - AH 10/04

Randomized phase III trial of 1 course BEP (Bleomycin, Etoposid, Cisplatin) versus 2 courses BEP adjuvant chemotherapy in patients with high-risk non-seminomatous germ cell tumors - AH 10/04 - AH 10/04

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00003520

Enrollment

580

Registered

2012-04-27

Start date

2004-10-10

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

testicular tumor C62

Interventions

Group 1: 1 course BEP (Bleomycin, Etoposid, Cisplatin) Cisplatin (Cisplatin Medac): 20 mg/m2 intravenous (30 minutes), days 1-5 Etoposide (Vepesid®): 100 mg/m2 intravenous (60 minutes), days 1-5 Bl

Eligibility

Sex/Gender

Male

Age

16 Years to 59 Years

Inclusion criteria

Inclusion criteria: - Histologically proven non-seminomatous germ cell tumor of the testis - Hostologically proven vascular invasion of the primary tumor into testicular veins or lymphatics - Clinical stage I patients (exclusion of persisting marker elevation after ablation of the testicle. lymph node metastases by CT of the abdomen and chest) - WHO performance status 0, 1, or 2 - Creatinune clearance > 40 ml/min - WBC > 3.0 G/l and platelets > 100 G/l - No previous chemotherapy - Contralateral TIN is allowed if the contralateral testis will be treated by radiation after repeat positive biopsy after chemotherapy - Before patient registration and randomisation, informed consent must be given according to ICH/EU GCP, and national/local regulations

Exclusion criteria

Exclusion criteria: - All patients with seminoma - All patients with non-seminoma > clinical stage I - All patients with missing vascular invasion - Previous chemotherapy - Patients with secondary malignancy except contralateral TIN and contralateral germ cell tumor treated by ablation and subsequent surveillance of more than 3 years - Intersex - WHO PS 3 and 4 - Patients with renal function impairment (creatinine clearance 1.25 x N and / or ASAT > 2 x N) - Patients with impaired pulmonary funktion according to pulmonary function test - Patients with serious illness or medical conditions incompatible with the protocol

Design outcomes

Primary

Measure	Time frame
Evaluation of the relapse rate in both arms. (Time Frame: 2 years)	—

Secondary

Measure	Time frame
- To evaluate treatment related acute and long-term toxicity. (parameter: Toxicities according to NCI / CTC Grade 3 Grade 4, Hematology, Audiometry, Pulmonary Function, Creatinine Clearance) --> Measurement time points: Follow-up Visit 1 (6 weeks after chemotherapy), Follow-up Visit (every 3 month) - To evaluate overall and disease-free survival. (Time Frame: 5 years) - To document health economical data concerning cost of treatment (number, methods and duration of follow up investigations dependent on the number, time, and location of relapses).	—

Measure

Time frame

- To evaluate treatment related acute and long-term toxicity. (parameter: Toxicities according to NCI / CTC Grade 3 Grade 4, Hematology, Audiometry, Pulmonary Function, Creatinine Clearance) --> Measurement time points: Follow-up Visit 1 (6 weeks after chemotherapy), Follow-up Visit (every 3 month) - To evaluate overall and disease-free survival. (Time Frame: 5 years) - To document health economical data concerning cost of treatment (number, methods and duration of follow up investigations dependent on the number, time, and location of relapses).

—

Countries

Australia, Belgium, France, Germany, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, United Kingdom

Contacts

Public ContactPeter Albers

Universitätsklinikum Düsseldorf

sekrurol@uni-duesseldorf.de0211/811-81 10

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026