- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02582697
Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours (P3BEP)
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
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: P3BEP Trial Coordinator
- Phone Number: 5000 +6195625000
- Email: p3bep@ctc.usyd.edu.au
Study Contact Backup
- Name: P3BEP Project Manager
- Phone Number: 5000 +6195625000
- Email: p3bep@ctc.usyd.edu.au
Study Locations
-
-
New South Wales
-
Newcastle, New South Wales, Australia, 2298
- Recruiting
- Calvary Mater Newcastle
-
Principal Investigator:
- Girish Mallesara
-
Contact:
- Louise Plowman
- Email: Louise.Plowman@calvarymater.org.au
-
Contact:
- Girish Mallesara
- Email: girish.mallesara@calvarymater.org.au
-
St Leonards, New South Wales, Australia, 2065
- Recruiting
- Royal North Shore Hospital
-
Contact:
- Susan Kirby-Lewis
- Email: Susan.KirbyLewis@health.nsw.gov.au
-
Contact:
- Alexander Guminski
- Email: aguminski@nsccahs.health.nsw.gov.au
-
Principal Investigator:
- Alexander Guminski
-
Sydney, New South Wales, Australia, 2031
- Recruiting
- Prince of Wales Hospital
-
Contact:
- Daisy Buchanan
- Email: Daisy.buchanan@sesiahs.health.nsw.gov.au
-
Contact:
- Julie Howard
- Email: Julie.howard@sesiahs.health.nsw.gov.au
-
Principal Investigator:
- Elizabeth Hovey
-
Sydney, New South Wales, Australia, 2050
- Recruiting
- Chris O'Brien Lifehouse
-
Contact:
- Melissa Quaggiott
- Email: melissa.mcmahon@lh.org.au
-
Contact:
- Peter Grimison
- Email: peter.grimison@lh.org.au
-
Principal Investigator:
- Peter Grimison
-
Sydney, New South Wales, Australia, 2139
- Recruiting
- Concord Repatriation General Hospital
-
Principal Investigator:
- Martin Stockler
-
Contact:
- Kathy Hall
- Email: Kathy.Hall@sswahs.nsw.gov.au
-
Contact:
- Martin Stockler
- Email: martin.stockler@sydney.edu.au
-
Sydney, New South Wales, Australia, 2109
- Recruiting
- Macquarie Cancer Clinical Trials
-
Contact:
- Louise Francisco
- Email: louise.francisco@mq.edu.au
-
Contact:
- Radhika Butala
- Email: radhika.butala@mq.edu.au
-
Sydney, New South Wales, Australia, 2145
- Withdrawn
- Westmead Hospital
-
Sydney, New South Wales, Australia, 2751
- Recruiting
- Nepean Hospital
-
Contact:
- Jeremy Jones
- Email: jeremy.jones@swahs.health.nsw.gov.au
-
Contact:
- Amanda Stevanovic
- Email: amanda.stevanovic@swahs.health.nsw.gov.au
-
Principal Investigator:
- Amanda Stevanovic
-
Tweed Heads, New South Wales, Australia, 2485
- Recruiting
- Tweed Hospital
-
Contact:
- Charmayne Chorlton
- Email: Charmayne.Chorlton@ncahs.health.nsw.gov.au
-
Contact:
- Ratnesh Srivastav
- Email: Ratnesh Srivastav <ratnesh.srivastav@health.nsw.gov.au>
-
Principal Investigator:
- Ratnesh Srivastav
-
Wahroonga, New South Wales, Australia, 2076
- Recruiting
- SAN Clinical Trials Unit
-
Principal Investigator:
- Gavin Marx
-
Contact:
- James McQuilan
- Email: James.McQuillan@sah.org.au
-
Contact:
- Gavin Marx
- Email: gmarx@nhog.com.au
-
-
Queensland
-
Brisbane, Queensland, Australia, 4029
- Recruiting
- Royal Brisbane & Women's Hospital
-
Contact:
- Natasha Roberts
- Email: natasha.roberts@health.qld.gov.au
-
Contact:
- David Wyld
- Email: david.wyld@health.qld.gov.au
-
Principal Investigator:
- David Wyld
-
South Brisbane, Queensland, Australia, 4101
- Recruiting
- Queensland CHILDREN'S HOSPITAL
-
Contact:
- Rick Walker
- Email: 'Rick.Walker@health.qld.gov.au'
-
Principal Investigator:
- Rick Walker
-
Woolloongabba, Queensland, Australia, 4102
- Recruiting
- Princess Alexandra
-
Contact:
- Paul Baxter
- Email: Paul.Baxter@health.qld.gov.au
-
Contact:
- Euan Walpole
- Email: Euan.Walpole@health.qld.gov.au
-
Principal Investigator:
- Euan Walpole
-
-
South Australia
-
Adelaide, South Australia, Australia, 5000
- Recruiting
- Royal Adelaide Hospital
-
Contact:
- Hazel Bourke
- Email: hazel.bourke@health.sa.gov.au
-
Contact:
- Thean Hsiang Tan
- Email: hsiang.tan@health.sa.gov.au
-
Principal Investigator:
- Thean Tan
-
Bedford Park, South Australia, Australia, 5042
- Active, not recruiting
- Flinders Medical Centre
-
-
Tasmania
-
Hobart, Tasmania, Australia, 7000
- Recruiting
- Royal Hobart Hospital
-
Principal Investigator:
- Rebecca Tay
-
Contact:
- Lesley Oliver
- Email: lesley.oliver@dhhs.tas.gov.au
-
Contact:
- Rebecca Tay
- Email: rebecca.tay@ths.tas.gov.au
-
-
Victoria
-
Box Hill, Victoria, Australia, 3128
- Recruiting
- Box Hill Hospital
-
Contact:
- Ian Davis
- Email: Ian.Davis@monash.edu
-
Contact:
- Lauren Mitchell
- Email: lauren.mitchell@monash.edu
-
East Melbourne, Victoria, Australia, 3002
- Recruiting
- Peter MacCallum Cancer Centre
-
Principal Investigator:
- Ben Tran
-
Contact:
- Jennifer Petersen
- Email: jennifer.petersen@petermac.org
-
Contact:
- Ben Tran
- Email: ben.tran@petermac.org
-
Heidelberg, Victoria, Australia, 3084
- Recruiting
- Austin Health
-
Contact:
- Jaren Caine
- Email: Jaren.Caine@austin.org.au
-
Contact:
- Andrew Weickhardt
- Email: Andrew.Weickhardt@ludwig.edu.au
-
St Albans, Victoria, Australia, 3021
- Withdrawn
- Sunshine Hospital
-
Wodonga, Victoria, Australia, 3690
- Recruiting
- Border Medical Oncology
-
Principal Investigator:
- Craig Underhill
-
Contact:
- Craig Underhill
- Email: cunderhill@bordermedonc.com.au
-
Contact:
- Lauren Callow
- Email: lcallow@bordermedonc.com.au
-
-
Western Australia
-
Murdoch, Western Australia, Australia, 6847
- Recruiting
- Fiona Stanley Hospital
-
Contact:
- Jaye Harding
- Email: jaye.harding@health.wa.gov.au
-
Contact:
- Simon Troon
- Email: simon.troon@health.wa.gov.au
-
Principal Investigator:
- Simon Troon
-
-
-
-
-
Christchurch, New Zealand, 8011
- Recruiting
- Christchurch Hospital
-
Contact:
- Elizabeth Thompson
- Email: liz.thompson@cdhb.health.nz
-
Contact:
- Mark Jeffrey
- Email: Mark.jeffery@cdhb.health.nz
-
Principal Investigator:
- Mark Jeffrey
-
Dunedin, New Zealand, 9054
- Withdrawn
- Dunedin Hospital
-
-
Auckland
-
Grafton, Auckland, New Zealand, 1023
- Recruiting
- Starship Children's Hospital
-
Contact:
- Mark Winstanley
- Email: 'mwinstanley@adhb.govt.nz'
-
Principal Investigator:
- Mark Winstanley
-
Grafton, Auckland, New Zealand, 1142
- Recruiting
- Auckland Hospital
-
Contact:
- Andrew Conley
- Email: andrewcon@adhb.govt.nz
-
Contact:
- Fritha Hanning
- Email: FrithaH@adhb.govt.nz
-
Principal Investigator:
- Fritha Hanning
-
-
Palmerston North
-
Roslyn, Palmerston North, New Zealand, 4442
- Recruiting
- Palmerston North Hospital
-
Contact:
- Sarah Holwell
- Email: Sarah.Holwell@midcentraldhb.govt.nz
-
Contact:
- Gary Forgeson
- Email: Garry.Forgeson@midcentraldhb.govt.nz
-
Principal Investigator:
- Gary Forgeson
-
-
-
-
New York
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Centre
-
Contact:
- Victoria Martorana
- Email: martorav@mskcc.org
-
Principal Investigator:
- Darren Feldman
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 11 years and ≤ 45 years on the date of randomisation
- 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
- Primary arising in testis, ovary, retro-peritoneum, or mediastinum
- Metastatic disease or non-testicular primary
- 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).
- Adequate bone marrow function with ANC ≥1.0 x 10^9/L, Platelet count ≥100 x 10^9/L
- 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
- 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
- ECOG Performance Status of 0, 1, 2, or 3
- Study treatment both planned and able to start within 14 days of randomisation.
- Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments
- Able to provide signed, written informed consent
Exclusion Criteria:
- Other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5 years previously with no evidence of recurrence)
Previous chemotherapy or radiotherapy, except if patient has pure seminoma relapsing after adjuvant radiotherapy or adjuvant chemotherapy with 1-2 doses of single agent carboplatin or if patient has non-seminoma and poor prognosis by IGCCC criteria in the rare case where low-dose induction chemotherapy is given prior to registration because patient is not fit enough to receive protocol chemotherapy (eg. organ failure, vena cava obstruction, overwhelming burden of disease). In these instances acceptable regimens include cisplatin 20 mg/m^2 days 1-2 and etoposide 100 mg/m^2 days 1-2; carboplatin AUC 3 days 1-2 and etoposide 100 mg/m^2 days 1-2; or baby-BOP. Patients must meet all other inclusion and exclusion criteria at the time of registration.
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.
- Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin
- Significant co-morbid respiratory disease that contraindicates the use of bleomycin
- Peripheral neuropathy ≥ grade 2 or clinically significant sensorineural hearing loss or tinnitus
- Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety
- Inadequate contraception. Men must use 2 effective methods of contraception, including use of a condom, during chemotherapy and for a year after completing chemotherapy.
- Known allergy or hypersensitivity to any of the study drugs
- 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
The above inclusion and exclusion criteria will apply to stage 1 (n=150) and stage 2 (n=500 including stage 1) of the study. All sites will participate in both stages of the study with the exception of the Children's Oncology Group who will be participate in stage 1 only.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard Arm - Standard BEP
Participants 16 years or older will receive 4 cycles of Standard BEP as follows:
Patients < 16 years old and weighs ≥ 45 kg will receive:
Patients <16 years old and weighs < 45 kg will receive:
Each cycle is 3 weeks (21 days). The planned total duration of treatment is 12 weeks. |
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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
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 Names:
|
Experimental: Experimental Arm - Accelerated BEP
Participants 16years or older will receive 4 cycles of Accelerated BEP as follows:
Patients <16years and weighs ≥45 kg will receive:
Patients <16years and weighs <45 kg will receive:
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. |
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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
PFS is measured from the date of randomisation until the criteria for disease progression are met (as defined in the protocol) or death.
Participants who are not observed to progress nor die will be censored at the date of last follow-up
|
From randomisation up to disease progression or date of death whichever come first, assessed up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initial response assessment
Time Frame: At end of chemotherapy treatment, treatment planned for 12 weeks
|
The assessment of response of germ cell tumours is measured by the change in size of measurable tumour masses in combination with changes in serum tumour markers after chemotherapy treatment.
|
At end of chemotherapy treatment, treatment planned for 12 weeks
|
Final response assessment
Time Frame: At 6 months
|
The assessment of response of germ cell tumours is measured by changes in serum tumour markers and imaging at 6 months from randomisation, or after any post-chemotherapy surgical resection or other intervention, whichever occurs last.
|
At 6 months
|
Adverse events (worst grade according to NCI CTCAE v4.03)
Time Frame: From start of chemotherapy until 30 days after last dose, an average of 4 months
|
The intensity of adverse events will be assessed using the NCI Common Terminology Criteria for Adverse Events version 4 (NCI CTCAE v4.03)
|
From start of chemotherapy until 30 days after last dose, an average of 4 months
|
Health-related quality of life
Time Frame: From date of randomisation until date of 18 month follow-up
|
HR-QoL measures will include the EORTC core quality of life questionnaire (QLQ-C30), a 30-item cancer-specific questionnaire that is well-validated and available in many languages.
|
From date of randomisation until date of 18 month follow-up
|
Health-related quality of life for testicular cancer
Time Frame: From date of randomisation until date of 18 month follow-up
|
EORTC quality of life module for testicular cancer (QLQ-TC26), a disease-specific measure with 26 items about physical symptoms, sexual functioning and emotional issues.
|
From date of randomisation until date of 18 month follow-up
|
Treatment preference
Time Frame: From date of randomisation until date of 18 month follow-up
|
A trial-specific preferences question will be used to determine if participants think they would prefer to be treated with accelerated BEP or standard BEP, assuming that they were equally effective.
|
From date of randomisation until date of 18 month follow-up
|
Delivered dose-intensity of chemotherapy (relative to standard BEP)
Time Frame: From start date of chemotherapy treatment until date of end of chemotherapy, an average of 12 weeks
|
Delivered dose-intensity of cisplatin, etoposide and bleomycin will be assessed.
|
From start date of chemotherapy treatment until date of end of chemotherapy, an average of 12 weeks
|
Overall survival
Time Frame: From randomisation up to disease progression or date of death whichever come first, assessed up to 5 years
|
Overall survival is measured from the date of randomisation until death from any cause, or the date of last known follow-up alive.
|
From randomisation up to disease progression or date of death whichever come first, assessed up to 5 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exploratory biomarker investigations
Time Frame: Baseline
|
Associations between biomarkers with survival will be assessed in the future.
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Peter Grimison, Chris O'Brien Lifehouse
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Germ Cell and Embryonal
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Etoposide
- Etoposide phosphate
- Cisplatin
- Bleomycin
Other Study ID Numbers
- ANZUP1302
- ACTRN12613000496718 (Registry Identifier: Australian New Zealand Clinical Trials Registry)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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