Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours
NCT ID: NCT02582697
Last Updated: 2025-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
500 participants
INTERVENTIONAL
2014-02-28
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Bleomycin (active name: Bleomycin Sulfate)
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
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
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)
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
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.
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.
Bleomycin (active name: Bleomycin Sulfate)
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
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
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)
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
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.
Interventions
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Bleomycin (active name: Bleomycin Sulfate)
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
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
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)
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma); or Exceptionally raised tumour markers (AFP ≥ 1000ng/mL and/or HCG ≥ 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumour burden, and a need to start therapy urgently
3. Primary arising in testis, ovary, retro-peritoneum, or mediastinum
4. Metastatic disease or non-testicular primary
5. Intermediate or poor prognosis as defined by IGCCC classification3 (modified with different LDH criteria for intermediate risk non-seminoma, and inclusion of ovarian primaries). (See protocol for more information).
6. Adequate bone marrow function with ANC ≥1.0 x 10\^9/L, Platelet count ≥100 x 10\^9/L
7. Adequate liver function where bilirubin must be ≤1.5 x ULN, except participants with Gilbert's Syndrome where bilirubin must be ≤2.0 x ULN; ALT and AST must be ≤2.5 x ULN, except if the elevations are due to hepatic metastases, in which case ALT and AST must be ≤ 5 x ULN
8. Adequate renal function with estimated creatinine clearance of ≥60 ml/min according to the Cockcroft-Gault formula, unless calculated to be \< 60 ml/min or borderline in which case GFR should be formally measured, eg. with EDTA scan
9. ECOG Performance Status of 0, 1, 2, or 3
10. Study treatment both planned and able to start within 14 days of randomisation.
11. Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments
12. Able to provide signed, written informed consent
Exclusion Criteria
Additionally participants who need to start therapy urgently prior to completing study-specific baseline investigations may commence study chemotherapy prior to registration and randomisation. Such patients must be discussed with the coordinating centre prior to registration, and must be registered within 10 days of commencing study chemotherapy.
3. Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin
4. Significant co-morbid respiratory disease that contraindicates the use of bleomycin
5. Peripheral neuropathy ≥ grade 2 or clinically significant sensorineural hearing loss or tinnitus
6. Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety
7. Inadequate contraception. Men must use 2 effective methods of contraception, including use of a condom, during chemotherapy and for a year after completing chemotherapy.
8. Known allergy or hypersensitivity to any of the study drugs
9. Presence of any psychological, familial, sociological or geographical condition that in the opinion of the investigator would hamper compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse
11 Years
50 Years
ALL
No
Sponsors
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Australian and New Zealand Urogenital and Prostate Cancer Trials Group
OTHER
Cambridge University Hospitals NHS Foundation Trust
OTHER
Cancer Trials Ireland
NETWORK
Children's Oncology Group
NETWORK
Dana-Farber Cancer Institute
OTHER
University of Southern California
OTHER
University of Sydney
OTHER
Responsible Party
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Principal Investigators
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Peter Grimison
Role: STUDY_CHAIR
Chris O'Brien Lifehouse
Locations
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Memorial Sloan Kettering Cancer Centre
New York, New York, United States
Calvary Mater Newcastle
Newcastle, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Prince of Wales Hospital
Sydney, New South Wales, Australia
Chris O'Brien Lifehouse
Sydney, New South Wales, Australia
Macquarie Cancer Clinical Trials
Sydney, New South Wales, Australia
Concord Repatriation General Hospital
Sydney, New South Wales, Australia
Westmead Hospital
Sydney, New South Wales, Australia
Nepean Hospital
Sydney, New South Wales, Australia
Tweed Hospital
Tweed Heads, New South Wales, Australia
SAN Clinical Trials Unit
Wahroonga, New South Wales, Australia
Royal Brisbane & Women's Hospital
Brisbane, Queensland, Australia
Queensland Children's Hospital
South Brisbane, Queensland, Australia
Princess Alexandra
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Sunshine Hospital
St Albans, Victoria, Australia
Border Medical Oncology
Wodonga, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Starship Children's Hospital
Grafton, Auckland, New Zealand
Auckland Hospital
Grafton, Auckland, New Zealand
Palmerston North Hospital
Roslyn, Palmerston North, New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Dunedin Hospital
Dunedin, , New Zealand
Countries
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Central Contacts
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Facility Contacts
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References
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Lawrence NJ, Chan H, Toner G, Stockler MR, Martin A, Yip S, Wong N, Yeung A, Mazhar D, Pashankar F, Frazier L, McDermott R, Walker R, Tan H, Davis ID, Grimison P; ANZUP. Protocol for the P3BEP trial (ANZUP 1302): an international randomised phase 3 trial of accelerated versus standard BEP chemotherapy for adult and paediatric male and female patients with intermediate and poor-risk metastatic germ cell tumours. BMC Cancer. 2018 Aug 29;18(1):854. doi: 10.1186/s12885-018-4745-3.
Other Identifiers
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ACTRN12613000496718
Identifier Type: REGISTRY
Identifier Source: secondary_id
ANZUP1302
Identifier Type: -
Identifier Source: org_study_id
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