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

Primary Purpose

Germ Cell Tumor

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bleomycin (active name: Bleomycin Sulfate)
Etoposide
Cisplatin
Pegylated G-CSF (Pegfilgrastim)
Filgrastim
Sponsored by
University of Sydney
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Germ Cell Tumor focused on measuring Germ Cell, Intermediate and poor-risk metastatic germ cell tumours

Eligibility Criteria

11 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan Kettering Cancer CentreRecruiting
  • Calvary Mater NewcastleRecruiting
  • Royal North Shore HospitalRecruiting
  • Prince of Wales HospitalRecruiting
  • Chris O'Brien LifehouseRecruiting
  • Macquarie Cancer Clinical TrialsRecruiting
  • Concord Repatriation General HospitalRecruiting
  • Westmead Hospital
  • Nepean HospitalRecruiting
  • Tweed HospitalRecruiting
  • SAN Clinical Trials UnitRecruiting
  • Royal Brisbane & Women's HospitalRecruiting
  • Queensland Children's HospitalRecruiting
  • Princess AlexandraRecruiting
  • Royal Adelaide HospitalRecruiting
  • Flinders Medical Centre
  • Royal Hobart HospitalRecruiting
  • Box Hill HospitalRecruiting
  • Peter MacCallum Cancer CentreRecruiting
  • Austin HealthRecruiting
  • Sunshine Hospital
  • Border Medical OncologyRecruiting
  • Fiona Stanley HospitalRecruiting
  • Starship Children's HospitalRecruiting
  • Auckland HospitalRecruiting
  • Palmerston North HospitalRecruiting
  • Christchurch HospitalRecruiting
  • Dunedin Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Arm - Standard BEP

Experimental Arm - Accelerated BEP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Progression-free survival (disease progression or death)
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
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
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)
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
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
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
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)
Delivered dose-intensity of cisplatin, etoposide and bleomycin will be assessed.
Overall survival
Overall survival is measured from the date of randomisation until death from any cause, or the date of last known follow-up alive.

Full Information

First Posted
September 7, 2015
Last Updated
November 25, 2021
Sponsor
University of Sydney
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
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1. Study Identification

Unique Protocol Identification Number
NCT02582697
Brief Title
Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours
Acronym
P3BEP
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 Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 2014 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sydney
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

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Germ Cell Tumor
Keywords
Germ Cell, Intermediate and poor-risk metastatic germ cell tumours

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Arm - Standard BEP
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experimental Arm - Accelerated BEP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bleomycin (active name: Bleomycin Sulfate)
Other Intervention Name(s)
Blenamax (Aspen), DBL Bleomycin Sulphate (Willow Pharmaceuticals Pty Limited), Bleo Powder for injection (Hospira)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
DBL Etoposide Injection (Hospira), Etopophos (Bristol-Myers Squibb), Etoposide (Pfizer), Etoposide Ebewe (Sandoz)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Cisplatin Ebewe (Sandoz), Cisplatin injection (Pfizer), DBL Cisplatin Injection (Hospira)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pegylated G-CSF (Pegfilgrastim)
Other Intervention Name(s)
Neulasta Syringe with Automatic Needle Guard (Amgen)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Filgrastim
Other Intervention Name(s)
Neupogen (Amgen), Nivestim (Hospira), Tevagrastim (Teva Pharma Australia Pty Ltd), Zarzio (Sandoz)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free survival (disease progression or death)
Description
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
Time Frame
From randomisation up to disease progression or date of death whichever come first, assessed up to 5 years
Secondary Outcome Measure Information:
Title
Initial response assessment
Description
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.
Time Frame
At end of chemotherapy treatment, treatment planned for 12 weeks
Title
Final response assessment
Description
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.
Time Frame
At 6 months
Title
Adverse events (worst grade according to NCI CTCAE v4.03)
Description
The intensity of adverse events will be assessed using the NCI Common Terminology Criteria for Adverse Events version 4 (NCI CTCAE v4.03)
Time Frame
From start of chemotherapy until 30 days after last dose, an average of 4 months
Title
Health-related quality of life
Description
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.
Time Frame
From date of randomisation until date of 18 month follow-up
Title
Health-related quality of life for testicular cancer
Description
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.
Time Frame
From date of randomisation until date of 18 month follow-up
Title
Treatment preference
Description
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.
Time Frame
From date of randomisation until date of 18 month follow-up
Title
Delivered dose-intensity of chemotherapy (relative to standard BEP)
Description
Delivered dose-intensity of cisplatin, etoposide and bleomycin will be assessed.
Time Frame
From start date of chemotherapy treatment until date of end of chemotherapy, an average of 12 weeks
Title
Overall survival
Description
Overall survival is measured from the date of randomisation until death from any cause, or the date of last known follow-up alive.
Time Frame
From randomisation up to disease progression or date of death whichever come first, assessed up to 5 years
Other Pre-specified Outcome Measures:
Title
Exploratory biomarker investigations
Description
Associations between biomarkers with survival will be assessed in the future.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
P3BEP Trial Coordinator
Phone
+6195625000
Ext
5000
Email
p3bep@ctc.usyd.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
P3BEP Project Manager
Phone
+6195625000
Ext
5000
Email
p3bep@ctc.usyd.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Grimison
Organizational Affiliation
Chris O'Brien Lifehouse
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Centre
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Martorana
Email
martorav@mskcc.org
First Name & Middle Initial & Last Name & Degree
Darren Feldman
Facility Name
Calvary Mater Newcastle
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise Plowman
Email
Louise.Plowman@calvarymater.org.au
First Name & Middle Initial & Last Name & Degree
Girish Mallesara
Email
girish.mallesara@calvarymater.org.au
First Name & Middle Initial & Last Name & Degree
Girish Mallesara
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Kirby-Lewis
Email
Susan.KirbyLewis@health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Alexander Guminski
Email
aguminski@nsccahs.health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Alexander Guminski
Facility Name
Prince of Wales Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daisy Buchanan
Email
Daisy.buchanan@sesiahs.health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Julie Howard
Email
Julie.howard@sesiahs.health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Elizabeth Hovey
Facility Name
Chris O'Brien Lifehouse
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Quaggiott
Email
melissa.mcmahon@lh.org.au
First Name & Middle Initial & Last Name & Degree
Peter Grimison
Email
peter.grimison@lh.org.au
First Name & Middle Initial & Last Name & Degree
Peter Grimison
Facility Name
Macquarie Cancer Clinical Trials
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise Francisco
Email
louise.francisco@mq.edu.au
First Name & Middle Initial & Last Name & Degree
Radhika Butala
Email
radhika.butala@mq.edu.au
First Name & Middle Initial & Last Name & Degree
Howard Gurney
Facility Name
Concord Repatriation General Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Hall
Email
Kathy.Hall@sswahs.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Martin Stockler
Email
martin.stockler@sydney.edu.au
First Name & Middle Initial & Last Name & Degree
Martin Stockler
Facility Name
Westmead Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Nepean Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2751
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy Jones
Email
jeremy.jones@swahs.health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Amanda Stevanovic
Email
amanda.stevanovic@swahs.health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Amanda Stevanovic
Facility Name
Tweed Hospital
City
Tweed Heads
State/Province
New South Wales
ZIP/Postal Code
2485
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charmayne Chorlton
Email
Charmayne.Chorlton@ncahs.health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Ratnesh Srivastav
Email
Ratnesh Srivastav <ratnesh.srivastav@health.nsw.gov.au>
First Name & Middle Initial & Last Name & Degree
Ratnesh Srivastav
Facility Name
SAN Clinical Trials Unit
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James McQuilan
Email
James.McQuillan@sah.org.au
First Name & Middle Initial & Last Name & Degree
Gavin Marx
Email
gmarx@nhog.com.au
First Name & Middle Initial & Last Name & Degree
Gavin Marx
Facility Name
Royal Brisbane & Women's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natasha Roberts
Email
natasha.roberts@health.qld.gov.au
First Name & Middle Initial & Last Name & Degree
David Wyld
Email
david.wyld@health.qld.gov.au
First Name & Middle Initial & Last Name & Degree
David Wyld
Facility Name
Queensland Children's Hospital
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rick Walker
Email
'Rick.Walker@health.qld.gov.au'
First Name & Middle Initial & Last Name & Degree
Rick Walker
Facility Name
Princess Alexandra
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Baxter
Email
Paul.Baxter@health.qld.gov.au
First Name & Middle Initial & Last Name & Degree
Euan Walpole
Email
Euan.Walpole@health.qld.gov.au
First Name & Middle Initial & Last Name & Degree
Euan Walpole
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hazel Bourke
Email
hazel.bourke@health.sa.gov.au
First Name & Middle Initial & Last Name & Degree
Thean Hsiang Tan
Email
hsiang.tan@health.sa.gov.au
First Name & Middle Initial & Last Name & Degree
Thean Tan
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lesley Oliver
Email
lesley.oliver@dhhs.tas.gov.au
First Name & Middle Initial & Last Name & Degree
Rebecca Tay
Email
rebecca.tay@ths.tas.gov.au
First Name & Middle Initial & Last Name & Degree
Rebecca Tay
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Mitchell
Email
lauren.mitchell@monash.edu
First Name & Middle Initial & Last Name & Degree
Ian Davis
Email
Ian.Davis@monash.edu
First Name & Middle Initial & Last Name & Degree
Ian Davis
Facility Name
Peter MacCallum Cancer Centre
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Petersen
Email
jennifer.petersen@petermac.org
First Name & Middle Initial & Last Name & Degree
Ben Tran
Email
ben.tran@petermac.org
First Name & Middle Initial & Last Name & Degree
Ben Tran
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaren Caine
Email
Jaren.Caine@austin.org.au
First Name & Middle Initial & Last Name & Degree
Andrew Weickhardt
Email
Andrew.Weickhardt@ludwig.edu.au
First Name & Middle Initial & Last Name & Degree
Andrew Weickhardt
Facility Name
Sunshine Hospital
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Border Medical Oncology
City
Wodonga
State/Province
Victoria
ZIP/Postal Code
3690
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Callow
Email
lcallow@bordermedonc.com.au
First Name & Middle Initial & Last Name & Degree
Craig Underhill
Email
cunderhill@bordermedonc.com.au
First Name & Middle Initial & Last Name & Degree
Craig Underhill
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6847
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaye Harding
Email
jaye.harding@health.wa.gov.au
First Name & Middle Initial & Last Name & Degree
Simon Troon
Email
simon.troon@health.wa.gov.au
First Name & Middle Initial & Last Name & Degree
Simon Troon
Facility Name
Starship Children's Hospital
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Winstanley
Email
'mwinstanley@adhb.govt.nz'
First Name & Middle Initial & Last Name & Degree
Mark Winstanley
Facility Name
Auckland Hospital
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1142
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Conley
Email
andrewcon@adhb.govt.nz
First Name & Middle Initial & Last Name & Degree
Fritha Hanning
Email
FrithaH@adhb.govt.nz
First Name & Middle Initial & Last Name & Degree
Fritha Hanning
Facility Name
Palmerston North Hospital
City
Roslyn
State/Province
Palmerston North
ZIP/Postal Code
4442
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Holwell
Email
Sarah.Holwell@midcentraldhb.govt.nz
First Name & Middle Initial & Last Name & Degree
Gary Forgeson
Email
Garry.Forgeson@midcentraldhb.govt.nz
First Name & Middle Initial & Last Name & Degree
Gary Forgeson
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Thompson
Email
liz.thompson@cdhb.health.nz
First Name & Middle Initial & Last Name & Degree
Mark Jeffrey
Email
Mark.jeffery@cdhb.health.nz
First Name & Middle Initial & Last Name & Degree
Mark Jeffrey
Facility Name
Dunedin Hospital
City
Dunedin
ZIP/Postal Code
9054
Country
New Zealand
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Citations:
PubMed Identifier
30157803
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.
Results Reference
derived

Learn more about this trial

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

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