Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours

Part of paid clinical trials in New York, New York.

Sponsor
University of Sydney
Study ID
NCT02582697
Phase
PHASE3
Status
Recruiting
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Conditions

  • Germ Cell Tumor

Eligibility Criteria

Sex
ALL
Age
11 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Bleomycin (active name: Bleomycin Sulfate) — DRUG
    Standard Arm: Bleomycin 30,000 international units IV weekly for 3 doses (eg. days 1, 8 and 15 or days 2, 9 and 16 of a 21-day cycle) for 4 cycles. Accelerated Arm: Bleomycin 30,000 international units IV weekly for 2 doses (eg. days 1 and 8 or days 2 and 9 of a 14-day cycle) for 4 cycles. Followed by Bleomycin 30,000 international units IV weekly for 4 doses.
  • Etoposide — DRUG
    Standard Arm: Etoposide 100 mg/m2 IV on days 1, 2, 3, 4, 5 of a 21-day cycle for 4 cycles. Accelerated Arm: 100 mg/m2 IV on days 1, 2, 3, 4, 5 of a 14-day cycle for 4 cycles.
  • Cisplatin — DRUG
    Standard Arm: Cisplatin 20 mg/m2 IV on days 1, 2, 3, 4, 5 of a 21-day cycle for 4 cycles. Accelerated Arm: Cisplatin 20 mg/m2 IV on days 1, 2, 3, 4, 5 of a 14-day cycle for 4 cycles.
  • Pegylated G-CSF (Pegfilgrastim) — DRUG
    Standard Arm: 6 mg SCI on day 6 of a 21-day cycle for 4 cycles. Accelerated Arm: 6 mg SCI on day 6 of a 14-day cycle for 4 cycles.
  • Filgrastim — DRUG
    Standard Arm: 10 mcg/kg/day on day6, until post-nadir absolute neutrophil count ≥ 1.0 x 10\^9/L, of a 21-day cycle for 4 cycles. Accelerated Arm: 10 mcg/kg/day on day 6, until post-nadir absolute neutrophil count ≥ 1.0 x 10\^9/L, of a 14-day cycle for 4 cycles.

Study Details

The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic germ cell tumours.

Key Dates

Start date
Feb 28, 2014
Status verified
Jun 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Arm - Standard BEP
    Participants 16 years or older will receive 4 cycles of Standard BEP as follows: * Bleomycin 30,000 IU IV weekly for 3 doses * Etoposide 100 mg/m2 IV on day 1 - 5 * Cisplatin 20 mg/m2 IV on day 1 - 5 * Pegylated G-CSF 6 mg SCI on day 6 Patients \< 16 years old and weighs ≥ 45 kg will receive: * Bleomycin \*15,000 - 30,000 IU IV weekly for 3 doses * Etoposide 100 mg/m2 IV on day 1 - 5 * Cisplatin 20 mg/m2 IV on day 1 - 5 * Pegylated G-CSF 6 mg SCI on day 6 Patients \<16 years old and weighs \< 45 kg will receive: * Bleomycin \*15,000 - 30,000 IU IV weekly for 3 doses * Etoposide 100 mg/m2 IV on day 1 - 5 * Cisplatin 20 mg/m2 IV on day 1 - 5 * Filgrastim 10mcg/kg/day on day 6, until post-nadir Absolute Neutrophil Count ≥1 x10\^9/ L * The dose of bleomycin is decided by the treating physician and based on the patient's Body Surface Area. Each cycle is 3 weeks (21 days). The planned total duration of treatment is 12 weeks.
  • Experimental: Experimental Arm - Accelerated BEP
    Participants 16years or older will receive 4 cycles of Accelerated BEP as follows: * Bleomycin 30,000 IU IV wkly for 2 doses * Etoposide 100 mg/m2 IV on day 1 - 5 * Cisplatin 20 mg/m2 IV on day 1- 5 * Pegylated G-CSF 6 mg SCI on day 6 Patients \<16years and weighs ≥45 kg will receive: * Bleomycin \*15,000 - 30,000 IU IV wkly for 2 doses * Etoposide 100 mg/m2 IV on day 1 - 5 * Cisplatin 20 mg/m2 IV on day 1 - 5 * Pegylated G-CSF 6 mg SCI on day 6 Patients \<16years and weighs \<45 kg will receive: * Bleomycin \*15,000 - 30,000 IU IV wkly for 2 doses * Etoposide 100 mg/m2 IV on day 1 - 5 * Cisplatin 20 mg/m2 IV on day 1 - 5 * Filgrastim 10mcg/kg/day on day 6, until ANC ≥1 x10\^9/ L Each cycle is 2 weeks (14days) Following 4xBEP cycles, patients will receive additional bleomycin as follows: \- Bleomycin \*15,000 - 30,000 IU IV wkly for 4 doses \* The dose of bleomycin is decided by the treating physician and based on the patient's BSA. The planned total duration is 12 weeks.

Primary Outcome Measure

Progression-free survival (disease progression or death) [ Time Frame: From randomisation up to disease progression or date of death whichever come first, assessed up to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CentreNew YorkNew York10065
Victoria Martorana
[email protected]
Darren Feldman (PRINCIPAL_INVESTIGATOR)

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By research site
Memorial Sloan Kettering Cancer Centre· New York, NY

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