RecruitingPhase 3ACTRN12613000496718

Phase 3 Accelerated BEP Trial: A randomised phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumours

In patients with intermediate and poor-risk metastatic germ cell tumours is an accelerated BEP chemotherapy regimen as good as, or better than, the standard BEP chemotherapy regimen for response rate.

Sponsor

University of Sydney

Enrollment

500 participants

Start Date

Apr 3, 2014

Study Type

Interventional

Conditions

Intermediate and poor-risk metastatic germ cell tumours (GCTs)

Summary

The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males and females with intermediate and poor-risk metastatic germ cell tumours. Who is it for? Male and female participants aged 11 years to 45 years old and you have been diagnosed with metastatic germ cell tumour/s in the testes, ovary, retro-peritoneum or mediastineum and considering first-line chemotherapy. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive the current gold standard treatment for germ cell tumours, which is a chemotherapy combination called BEP (bleomycin, etoposide and cisplatin) administered on a 3 weekly cycle. BEP is given with a drug called pegfilgrastim which encourages white blood cell production and prevents blood cell complications of chemotherapy. Participants in the other group will receive the same dose of BEP but on a 2 weekly schedule. This is called 'accelerated BEP'. Participants will be regularly assessed for treatment response, side effects and quality of life for a period of up to 2 years. This will enable us to determine whether giving the dose of BEP on a 2 weekly schedule is more effective than a 3 weekly schedule. We will also be able to track whether the shorter schedule causes more, the same, or less side effects.

Eligibility

Sex: Both males and femalesMin Age: 11 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two schedules of a powerful chemotherapy combination called BEP (bleomycin, etoposide, and cisplatin) for people with intermediate or poor-risk metastatic germ cell tumours — cancers that can arise in the testicles, ovaries, or other areas. The standard schedule gives BEP every 3 weeks. The trial is testing whether giving the same doses every 2 weeks ("accelerated BEP") works better. Participants are randomly assigned to one of the two schedules and followed for up to 2 years to track response, side effects, and quality of life. You may be eligible if: - You are between 11 and 45 years old - You have been diagnosed with a metastatic germ cell tumour (testicular, ovarian, retroperitoneal, or mediastinal) - Your cancer is classified as intermediate or poor risk - You have not yet started chemotherapy (or are in very early pre-protocol treatment) - Your blood counts, liver function, and kidney function are adequate - You have an ECOG performance status of 0–3 (able to care for yourself) You may NOT be eligible if: - You have a history of a prior cancer other than skin cancer or germ cell tumour - You have previously received chemotherapy or radiotherapy (with limited exceptions) - You have serious heart or lung disease that prevents IV fluid or bleomycin use - You have significant nerve problems, hearing loss, or severe infection - You have a known allergy to any of the study drugs Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients 16 years or older and randomised to Arm B - Accelerated BEP (Experimental) will receive 4 x 14 day cycles of; Bleomycin 30000 IU IV weekly; Etoposide 100mg/m^2 IV days 1,2,3,4,5; Cisplatin

Patients 16 years or older and randomised to Arm B - Accelerated BEP (Experimental) will receive 4 x 14 day cycles of; Bleomycin 30000 IU IV weekly; Etoposide 100mg/m^2 IV days 1,2,3,4,5; Cisplatin 20mg/m^2 IV days 1,2,3,4,5 and Pegylated G-CSF 6mg SCI on day 6 followed by: 4 doses of Bleomycin 30000IU IV at weekly intervals. Patients less than 16 years old and weighs 45 kgs or more and are randomised to Arm B - Accelerated BEP (Experimental) will receive; Bleomycin 15,000 - 30000 IU IV weekly; Etoposide 100mg/m^2 IV days 1,2,3,4,5; Cisplatin 20mg/m^2 IV days 1,2,3,4,5 and Pegylated G-CSF 6mg SCI on day 6 followed by: 4 doses of Bleomycin 15,000-30000IU IV at weekly intervals. Patients aged less than 16 years and weigh less than 45 kg on day 1 of the treatment cycle and are randomised to Arm B - Accelerated BEP (Experimental) will receive Bleomycin 15,000 - 30000 IU IV weekly; Etoposide 100mg/m^2 IV days 1,2,3,4,5; Cisplatin 20mg/m^2 IV days 1,2,3,4,5 and Filgrastim 10mcg/kg/day until post-nadir absolute neutrophil count is equal to or greater than 1 x 10^9/ L - dose starting day 6 followed by: 4 doses of Bleomycin 15,000-30000IU IV at weekly intervals. For patients less than 16 years old, the exact dose of bleomycin is decided by the treating physician and based on the patients body surface area (BSA) value.