Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours (P3BEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02582697

Recruitment Status : Recruiting

First Posted : October 21, 2015

Last Update Posted : November 29, 2021

See Contacts and Locations

View this study on Beta.ClinicalTrials.gov

Sponsor:

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

Information provided by (Responsible Party):

University of Sydney

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Germ Cell Tumor	Drug: Bleomycin (active name: Bleomycin Sulfate) Drug: Etoposide Drug: Cisplatin Drug: Pegylated G-CSF (Pegfilgrastim) Drug: Filgrastim	Phase 3

Detailed Description:

Bleomycin, Etoposide, Cisplatin (BEP) administered 3-weekly x 4 remains standard 1st line chemotherapy for intermediate- and poor-risk metastatic germ cell tumours (GCTs). Cure rates are over 90% for good-risk disease, 85% with intermediate-risk, and about 70% for poor-risk disease. Previous strategies to improve first-line chemotherapy have failed to improve cure rates and were more toxic than BEP. New strategies are needed for patients with intermediate and poor-risk disease. BEP is accelerated by cycling Cisplatin and etoposide 2-weekly instead of 3-weekly. The Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) is conducting a trial comparing accelerated BEP with standard BEP. The aim of this study is to determine if accelerated BEP is superior to standard BEP as first-line chemotherapy for intermediate and poor risk metastatic GCTs.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	500 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Actual Study Start Date :	February 2014
Estimated Primary Completion Date :	February 2022
Estimated Study Completion Date :	July 2023

Arms and Interventions

Arm	Intervention/treatment
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.	Drug: 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. Other Names: Blenamax (Aspen) DBL Bleomycin Sulphate (Willow Pharmaceuticals Pty Limited) Bleo Powder for injection (Hospira) Drug: 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. Other Names: DBL Etoposide Injection (Hospira) Etopophos (Bristol-Myers Squibb) Etoposide (Pfizer) Etoposide Ebewe (Sandoz) Drug: 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. Other Names: Cisplatin Ebewe (Sandoz) Cisplatin injection (Pfizer) DBL Cisplatin Injection (Hospira) Drug: 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. Other Name: Neulasta Syringe with Automatic Needle Guard (Amgen) Drug: 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 Names: Neupogen (Amgen) Nivestim (Hospira) Tevagrastim (Teva Pharma Australia Pty Ltd) Zarzio (Sandoz)
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.	Drug: 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. Other Names: Blenamax (Aspen) DBL Bleomycin Sulphate (Willow Pharmaceuticals Pty Limited) Bleo Powder for injection (Hospira) Drug: 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. Other Names: DBL Etoposide Injection (Hospira) Etopophos (Bristol-Myers Squibb) Etoposide (Pfizer) Etoposide Ebewe (Sandoz) Drug: 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. Other Names: Cisplatin Ebewe (Sandoz) Cisplatin injection (Pfizer) DBL Cisplatin Injection (Hospira) Drug: 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. Other Name: Neulasta Syringe with Automatic Needle Guard (Amgen) Drug: 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 Names: Neupogen (Amgen) Nivestim (Hospira) Tevagrastim (Teva Pharma Australia Pty Ltd) Zarzio (Sandoz)

Arm

Intervention/treatment

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.

Drug: 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.

Other Names:

Blenamax (Aspen)
DBL Bleomycin Sulphate (Willow Pharmaceuticals Pty Limited)
Bleo Powder for injection (Hospira)

Drug: 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.

Other Names:

DBL Etoposide Injection (Hospira)
Etopophos (Bristol-Myers Squibb)
Etoposide (Pfizer)
Etoposide Ebewe (Sandoz)

Drug: 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.

Other Names:

Cisplatin Ebewe (Sandoz)
Cisplatin injection (Pfizer)
DBL Cisplatin Injection (Hospira)

Drug: 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.

Other Name: Neulasta Syringe with Automatic Needle Guard (Amgen)

Drug: 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 Names:

Neupogen (Amgen)
Nivestim (Hospira)
Tevagrastim (Teva Pharma Australia Pty Ltd)
Zarzio (Sandoz)

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.

Drug: 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.

Other Names:

Blenamax (Aspen)
DBL Bleomycin Sulphate (Willow Pharmaceuticals Pty Limited)
Bleo Powder for injection (Hospira)

Drug: 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.

Other Names:

DBL Etoposide Injection (Hospira)
Etopophos (Bristol-Myers Squibb)
Etoposide (Pfizer)
Etoposide Ebewe (Sandoz)

Drug: 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.

Other Names:

Cisplatin Ebewe (Sandoz)
Cisplatin injection (Pfizer)
DBL Cisplatin Injection (Hospira)

Drug: 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.

Other Name: Neulasta Syringe with Automatic Needle Guard (Amgen)

Drug: 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 Names:

Neupogen (Amgen)
Nivestim (Hospira)
Tevagrastim (Teva Pharma Australia Pty Ltd)
Zarzio (Sandoz)

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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.
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.
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)
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.
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.
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.
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.
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.

Other Outcome Measures:

Exploratory biomarker investigations [ Time Frame: Baseline ]
Associations between biomarkers with survival will be assessed in the future.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	11 Years to 45 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02582697

Contacts

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Contact: P3BEP Trial Coordinator	+6195625000 ext 5000	p3bep@ctc.usyd.edu.au
Contact: P3BEP Project Manager	+6195625000 ext 5000	p3bep@ctc.usyd.edu.au

Locations

Show 28 study locations

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United States, New York
Memorial Sloan Kettering Cancer Centre	Recruiting
New York, New York, United States, 10065
Contact: Victoria Martorana martorav@mskcc.org
Principal Investigator: Darren Feldman
Australia, New South Wales
Calvary Mater Newcastle	Recruiting
Newcastle, New South Wales, Australia, 2298
Contact: Louise Plowman Louise.Plowman@calvarymater.org.au
Contact: Girish Mallesara girish.mallesara@calvarymater.org.au
Principal Investigator: Girish Mallesara
Royal North Shore Hospital	Recruiting
St Leonards, New South Wales, Australia, 2065
Contact: Susan Kirby-Lewis Susan.KirbyLewis@health.nsw.gov.au
Contact: Alexander Guminski aguminski@nsccahs.health.nsw.gov.au
Principal Investigator: Alexander Guminski
Prince of Wales Hospital	Recruiting
Sydney, New South Wales, Australia, 2031
Contact: Daisy Buchanan Daisy.buchanan@sesiahs.health.nsw.gov.au
Contact: Julie Howard Julie.howard@sesiahs.health.nsw.gov.au
Principal Investigator: Elizabeth Hovey
Chris O'Brien Lifehouse	Recruiting
Sydney, New South Wales, Australia, 2050
Contact: Melissa Quaggiott melissa.mcmahon@lh.org.au
Contact: Peter Grimison peter.grimison@lh.org.au
Principal Investigator: Peter Grimison
Macquarie Cancer Clinical Trials	Recruiting
Sydney, New South Wales, Australia, 2109
Contact: Louise Francisco louise.francisco@mq.edu.au
Contact: Radhika Butala radhika.butala@mq.edu.au
Principal Investigator: Howard Gurney
Concord Repatriation General Hospital	Recruiting
Sydney, New South Wales, Australia, 2139
Contact: Kathy Hall Kathy.Hall@sswahs.nsw.gov.au
Contact: Martin Stockler martin.stockler@sydney.edu.au
Principal Investigator: Martin Stockler
Westmead Hospital	Withdrawn
Sydney, New South Wales, Australia, 2145
Nepean Hospital	Recruiting
Sydney, New South Wales, Australia, 2751
Contact: Jeremy Jones jeremy.jones@swahs.health.nsw.gov.au
Contact: Amanda Stevanovic amanda.stevanovic@swahs.health.nsw.gov.au
Principal Investigator: Amanda Stevanovic
Tweed Hospital	Recruiting
Tweed Heads, New South Wales, Australia, 2485
Contact: Charmayne Chorlton Charmayne.Chorlton@ncahs.health.nsw.gov.au
Contact: Ratnesh Srivastav Ratnesh Srivastav <ratnesh.srivastav@health.nsw.gov.au>
Principal Investigator: Ratnesh Srivastav
SAN Clinical Trials Unit	Recruiting
Wahroonga, New South Wales, Australia, 2076
Contact: James McQuilan James.McQuillan@sah.org.au
Contact: Gavin Marx gmarx@nhog.com.au
Principal Investigator: Gavin Marx
Australia, Queensland
Royal Brisbane & Women's Hospital	Recruiting
Brisbane, Queensland, Australia, 4029
Contact: Natasha Roberts natasha.roberts@health.qld.gov.au
Contact: David Wyld david.wyld@health.qld.gov.au
Principal Investigator: David Wyld
Queensland Children's Hospital	Recruiting
South Brisbane, Queensland, Australia, 4101
Contact: Rick Walker 'Rick.Walker@health.qld.gov.au'
Principal Investigator: Rick Walker
Princess Alexandra	Recruiting
Woolloongabba, Queensland, Australia, 4102
Contact: Paul Baxter Paul.Baxter@health.qld.gov.au
Contact: Euan Walpole Euan.Walpole@health.qld.gov.au
Principal Investigator: Euan Walpole
Australia, South Australia
Royal Adelaide Hospital	Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Hazel Bourke hazel.bourke@health.sa.gov.au
Contact: Thean Hsiang Tan hsiang.tan@health.sa.gov.au
Principal Investigator: Thean Tan
Flinders Medical Centre	Active, not recruiting
Bedford Park, South Australia, Australia, 5042
Australia, Tasmania
Royal Hobart Hospital	Recruiting
Hobart, Tasmania, Australia, 7000
Contact: Lesley Oliver lesley.oliver@dhhs.tas.gov.au
Contact: Rebecca Tay rebecca.tay@ths.tas.gov.au
Principal Investigator: Rebecca Tay
Australia, Victoria
Box Hill Hospital	Recruiting
Box Hill, Victoria, Australia, 3128
Contact: Lauren Mitchell lauren.mitchell@monash.edu
Contact: Ian Davis Ian.Davis@monash.edu
Principal Investigator: Ian Davis
Peter MacCallum Cancer Centre	Recruiting
East Melbourne, Victoria, Australia, 3002
Contact: Jennifer Petersen jennifer.petersen@petermac.org
Contact: Ben Tran ben.tran@petermac.org
Principal Investigator: Ben Tran
Austin Health	Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Jaren Caine Jaren.Caine@austin.org.au
Contact: Andrew Weickhardt Andrew.Weickhardt@ludwig.edu.au
Principal Investigator: Andrew Weickhardt
Sunshine Hospital	Withdrawn
St Albans, Victoria, Australia, 3021
Border Medical Oncology	Recruiting
Wodonga, Victoria, Australia, 3690
Contact: Lauren Callow lcallow@bordermedonc.com.au
Contact: Craig Underhill cunderhill@bordermedonc.com.au
Principal Investigator: Craig Underhill
Australia, Western Australia
Fiona Stanley Hospital	Recruiting
Murdoch, Western Australia, Australia, 6847
Contact: Jaye Harding jaye.harding@health.wa.gov.au
Contact: Simon Troon simon.troon@health.wa.gov.au
Principal Investigator: Simon Troon
New Zealand
Starship Children's Hospital	Recruiting
Grafton, Auckland, New Zealand, 1023
Contact: Mark Winstanley 'mwinstanley@adhb.govt.nz'
Principal Investigator: Mark Winstanley
Auckland Hospital	Recruiting
Grafton, Auckland, New Zealand, 1142
Contact: Andrew Conley andrewcon@adhb.govt.nz
Contact: Fritha Hanning FrithaH@adhb.govt.nz
Principal Investigator: Fritha Hanning
Palmerston North Hospital	Recruiting
Roslyn, Palmerston North, New Zealand, 4442
Contact: Sarah Holwell Sarah.Holwell@midcentraldhb.govt.nz
Contact: Gary Forgeson Garry.Forgeson@midcentraldhb.govt.nz
Principal Investigator: Gary Forgeson
Christchurch Hospital	Recruiting
Christchurch, New Zealand, 8011
Contact: Elizabeth Thompson liz.thompson@cdhb.health.nz
Contact: Mark Jeffrey Mark.jeffery@cdhb.health.nz
Principal Investigator: Mark Jeffrey
Dunedin Hospital	Withdrawn
Dunedin, New Zealand, 9054

Sponsors and Collaborators

University of Sydney

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

Investigators

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Study Chair:	Peter Grimison	Chris O'Brien Lifehouse

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	University of Sydney
ClinicalTrials.gov Identifier:	NCT02582697
Other Study ID Numbers:	ANZUP1302 ACTRN12613000496718 ( Registry Identifier: Australian New Zealand Clinical Trials Registry )
First Posted:	October 21, 2015 Key Record Dates
Last Update Posted:	November 29, 2021
Last Verified:	November 2021

Keywords provided by University of Sydney:


Germ Cell Intermediate and poor-risk metastatic germ cell tumours

Additional relevant MeSH terms:

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Neoplasms, Germ Cell and Embryonal Neoplasms Neoplasms by Histologic Type Cisplatin Etoposide Etoposide phosphate Bleomycin	Antineoplastic Agents Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antibiotics, Antineoplastic

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