{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"P3BEP","nct_id":"NCT02582697","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=p3bep-nct02582697. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"P3BEP","arms":[{"description":"Participants 16 years or older will receive 4 cycles of Standard BEP as follows:\n\n* Bleomycin 30,000 IU IV weekly for 3 doses\n* Etoposide 100 mg/m2 IV on day 1 - 5\n* Cisplatin 20 mg/m2 IV on day 1 - 5\n* Pegylated G-CSF 6 mg SCI on day 6\n\nPatients \\< 16 years old and weighs ≥ 45 kg will receive:\n\n* Bleomycin \\*15,000 - 30,000 IU IV weekly for 3 doses\n* Etoposide 100 mg/m2 IV on day 1 - 5\n* Cisplatin 20 mg/m2 IV on day 1 - 5\n* Pegylated G-CSF 6 mg SCI on day 6\n\nPatients \\<16 years old and weighs \\< 45 kg will receive:\n\n* Bleomycin \\*15,000 - 30,000 IU IV weekly for 3 doses\n* Etoposide 100 mg/m2 IV on day 1 - 5\n* Cisplatin 20 mg/m2 IV on day 1 - 5\n* Filgrastim 10mcg/kg/day on day 6, until post-nadir Absolute Neutrophil Count ≥1 x10\\^9/ L\n\n  * The dose of bleomycin is decided by the treating physician and based on the patient's Body Surface Area.\n\nEach cycle is 3 weeks (21 days).\n\nThe planned total duration of treatment is 12 weeks.","label":"Standard Arm - Standard BEP","type":"ACTIVE_COMPARATOR"},{"description":"Participants 16years or older will receive 4 cycles of Accelerated BEP as follows:\n\n* Bleomycin 30,000 IU IV wkly for 2 doses\n* Etoposide 100 mg/m2 IV on day 1 - 5\n* Cisplatin 20 mg/m2 IV on day 1- 5\n* Pegylated G-CSF 6 mg SCI on day 6\n\nPatients \\<16years and weighs ≥45 kg will receive:\n\n* Bleomycin \\*15,000 - 30,000 IU IV wkly for 2 doses\n* Etoposide 100 mg/m2 IV on day 1 - 5\n* Cisplatin 20 mg/m2 IV on day 1 - 5\n* Pegylated G-CSF 6 mg SCI on day 6\n\nPatients \\<16years and weighs \\<45 kg will receive:\n\n* Bleomycin \\*15,000 - 30,000 IU IV wkly for 2 doses\n* Etoposide 100 mg/m2 IV on day 1 - 5\n* Cisplatin 20 mg/m2 IV on day 1 - 5\n* Filgrastim 10mcg/kg/day on day 6, until ANC ≥1 x10\\^9/ L\n\nEach cycle is 2 weeks (14days)\n\nFollowing 4xBEP cycles, patients will receive additional bleomycin as follows:\n\n\\- Bleomycin \\*15,000 - 30,000 IU IV wkly for 4 doses\n\n\\* The dose of bleomycin is decided by the treating physician and based on the patient's BSA.\n\nThe planned total duration is 12 weeks.","label":"Experimental Arm - Accelerated BEP","type":"EXPERIMENTAL"}],"collaborators":["Australian and New Zealand Urogenital and Prostate Cancer Trials Group","Cambridge University Hospitals NHS Foundation Trust","Cancer Trials Ireland","Children's Oncology Group","Dana-Farber Cancer Institute","University of Southern California"],"completion_date":{"date":"2029-12-31","type":"ESTIMATED"},"conditions":["Germ Cell Tumor"],"enrollment":{"count":500,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Bleomycin (active name: Bleomycin Sulfate)","otherNames":["Blenamax (Aspen)","DBL Bleomycin Sulphate (Willow Pharmaceuticals Pty Limited)","Bleo Powder for injection (Hospira)"],"type":"DRUG"},{"name":"Etoposide","otherNames":["DBL Etoposide Injection (Hospira)","Etopophos (Bristol-Myers Squibb)","Etoposide (Pfizer)","Etoposide Ebewe (Sandoz)"],"type":"DRUG"},{"name":"Cisplatin","otherNames":["Cisplatin Ebewe (Sandoz)","Cisplatin injection (Pfizer)","DBL Cisplatin Injection (Hospira)"],"type":"DRUG"},{"name":"Pegylated G-CSF (Pegfilgrastim)","otherNames":["Neulasta Syringe with Automatic Needle Guard (Amgen)"],"type":"DRUG"},{"name":"Filgrastim","otherNames":["Neupogen (Amgen)","Nivestim (Hospira)","Tevagrastim (Teva Pharma Australia Pty Ltd)","Zarzio (Sandoz)"],"type":"DRUG"}],"last_update":"2026-09-01","lead_sponsor":"University of Sydney","official_title":"Phase 3 Accelerated BEP: A Randomised Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours","overall_status":"RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2029-12-31","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Progression-free survival (disease progression or death)","timeFrame":"From randomisation up to disease progression or date of death whichever come first, assessed up to 5 years"}],"references":[{"citation":"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.","pmid":"30157803","type":"DERIVED"}],"start_date":{"date":"2014-02","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours","url":"https://clinicaltrials.gov/study/NCT02582697"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/p3bep-nct02582697"}