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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 : July 11, 2017
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

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.

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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
Study Start Date : February 2014
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : July 2023

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)




Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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)

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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:
  1. Exploratory biomarker investigations [ Time Frame: Baseline ]
    Associations between biomarkers with survival will be assessed in the future.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  1. Age ≥ 11 years and ≤ 45 years on the date of randomisation
  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:

  1. 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)
  2. 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.

  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

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.


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
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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 Recruiting
Sydney, New South Wales, Australia, 2145
Contact: Vicky Wegener       vicky.wegener@sydney.edu.au   
Contact: Howard Gurney       howard_gurney@wmi.usyd.edu.au   
Principal Investigator: Howard Gurney         
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: Ehtesham Abdi       eaabdi@mac.com   
Principal Investigator: Ehtesham Abdi         
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         
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 Recruiting
Bedford Park, South Australia, Australia, 5042
Contact: Alex Scott-Hoy       Alex.Scott-Hoy@health.sa.gov.au   
Contact: Ganessan Kichenadasse       Ganessan.Kichenadasse@health.sa.gov.au   
Principal Investigator: Ganessan Kichenadasse         
Australia, Tasmania
Royal Hobart Hospital Recruiting
Hobart, Tasmania, Australia, 7000
Contact: Lesley Oliver       lesley.oliver@dhhs.tas.gov.au   
Contact: David Boadle       david.boadle@dhhs.tas.gov.au   
Principal Investigator: David Boadle         
Australia, Victoria
Box Hill Hospital Recruiting
Box Hill, Victoria, Australia, 3128
Contact: Lauren Mitchell       lauren.mitchell@monash.edu   
Contact: Philip Parente       Phillip.parente@monash.edu   
Principal Investigator: Philip Parente         
Peter MacCallum Cancer Centre Recruiting
East Melbourne, Victoria, Australia, 3002
Contact: Jennifer Petersen       jennifer.petersen@petermac.org   
Contact: Guy Toner       guy.toner@petermac.org   
Principal Investigator: Guy Toner         
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 Recruiting
St Albans, Victoria, Australia, 3021
Contact: Jessica Tanner       Jessica.Tanner@wh.org.au   
Contact: Shirley Wong       shirleys.wong@mh.org.au   
Principal Investigator: Shirley Wong         
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
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 Recruiting
Dunedin, New Zealand, 9054
Contact: Rachel McLay-Barnes       ONCRESEARCH@southerndhb.govt.nz   
Contact: David Perez       david.perez@southerndhb.govt.nz   
Principal Investigator: David Perez         
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Sydney
ClinicalTrials.gov Identifier: NCT02582697     History of Changes
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: July 11, 2017
Last Verified: July 2017
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
Lenograstim
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic