ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12605000142639

Ethics application status

Approved

Date submitted

9/08/2005

Date registered

12/08/2005

Date last updated

5/10/2011

Type of registration

Retrospectively registered

Titles & IDs

Public title

Good Prognosis Germ Cell Trial

Scientific title

Randomised, Phase III, trial for good prognosis germ cell tumours comparing two different regimes of cisplatin, etoposide and bleomycin.

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Histologically confirmed germ cell tumour (seminoma or non-seminoma) with measurable disease or raised concentrations of tumor markers in serum.

Condition category

Condition code

Cancer

Testicular

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A multicentre randomised trial to compare two standard chemotherapy regimens for men with good prognosis germ cell tumours. Treatment arm A and B both consisted of cisplatin, etoposide and bleomycin, but was different in doses and the number of cycles. The trial was stopped when the second planned interim analysis met predefined stopping rules. Overall survival was substantially better with treatment arm A.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control group

Active

Outcomes

Primary outcome [1]

To compare in a randomised trial the response proportions, relapse-free and failure-free, of combination chemotherapy programs, each comprising of cisplatin, etoposide and bleomycin in patients with germ cell tumours and a good prognosis.

Timepoint [1]

Primary outcome [2]

To compare in a randomised trial the overall survival of combination chemotherapy programs, each comprising of cisplatin, etoposide and bleomycin in patients with germ cell tumours and a good prognosis.

Timepoint [2]

Primary outcome [3]

To compare in a randomised trial the toxicity of combination chemotherapy programs, each comprising of cisplatin, etoposide and bleomycin in patients with germ cell tumours and a good prognosis.

Timepoint [3]

Primary outcome [4]

To compare in a randomised trial the cost of combination chemotherapy programs, each comprising of cisplatin, etoposide and bleomycin in patients with germ cell tumours and a good prognosis.

Timepoint [4]

Primary outcome [5]

To assess the quality of life of patients receiving each of the chemotherapy regimens.

Timepoint [5]

Secondary outcome [1]

To evaluate the value of measuring the rate of fall of alpha-fetoprotein and Human Chorionic Gonadotrophin as an early predictor of response.

Timepoint [1]

Serum Tumour markers (aFP and HCG) were performed pre-study, weekly (while tumour marker is elevated), prior to each cycle and off study.

Eligibility

Key inclusion criteria

1. Histologically confirmed germ cell tumour.2. All patients have measureable disease 3. Patients with pure and non-seminomatous arising at any site defined as good risk by the MSKCC classification. 4. no prior chemotherapy.

Minimum age

Not stated

Maximum age

Not stated

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Germ cell tumours not arising in the testes, retroperitoneum or mediastinum. 2. Patients classified to have poor prognosis according to the International Germ Cell Consensus Classification. 3. Patients with cerebral metastases.4. Previous or current second malignancy.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation was made from a central site and randomisation was performed at the time of registration.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Stratification for treating institution and primary histology (pure seminoma Vs non-seminoma) by use of a dynamic balancing algorithm.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

5/01/1994

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

260

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

NSW Cancer Council

Address [2]

Country [2]

Australia

Funding source category [3]

Charities/Societies/Foundations

Name [3]

donation from Apex Foundationand Apex Clubs of Australia

Address [3]

Country [3]

Australia

Primary sponsor type

Government body

Name

Australian and New Zealand Germ Cell Trials Group at NHMRC Clinical Trials Centre

Address

Country

Australia

Secondary sponsor category [1]

Charities/Societies/Foundations

Name [1]

NSW Cancer Council and Apex

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Princess Alexandra

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Ethics committee name [2]

Peter MacCallum Cancer Insitute

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

Ethics approval number [2]

Ethics committee name [3]

Royal Prince alfred

Ethics committee address [3]

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

Ethics approval number [3]

Ethics committee name [4]

Liverpool

Ethics committee address [4]

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

Approval date [4]

Ethics approval number [4]

Ethics committee name [5]

Westmead

Ethics committee address [5]

Ethics committee country [5]

Australia

Date submitted for ethics approval [5]

Approval date [5]

Ethics approval number [5]

Ethics committee name [6]

Geelong

Ethics committee address [6]

Ethics committee country [6]

Australia

Date submitted for ethics approval [6]

Approval date [6]

Ethics approval number [6]

Ethics committee name [7]

Newcastle Mater Misericordiae

Ethics committee address [7]

Ethics committee country [7]

Australia

Date submitted for ethics approval [7]

Approval date [7]

Ethics approval number [7]

Ethics committee name [8]

Prince of Wales

Ethics committee address [8]

Ethics committee country [8]

Australia

Date submitted for ethics approval [8]

Approval date [8]

Ethics approval number [8]

Ethics committee name [9]

St Vincents

Ethics committee address [9]

Ethics committee country [9]

Australia

Date submitted for ethics approval [9]

Approval date [9]

Ethics approval number [9]

Ethics committee name [10]

The Canberra Hospital

Ethics committee address [10]

VIC

Ethics committee country [10]

Australia

Date submitted for ethics approval [10]

Approval date [10]

Ethics approval number [10]

Ethics committee name [11]

Royal perth

Ethics committee address [11]

Ethics committee country [11]

Australia

Date submitted for ethics approval [11]

Approval date [11]

Ethics approval number [11]

Ethics committee name [12]

Royal Hobart

Ethics committee address [12]

Ethics committee country [12]

Australia

Date submitted for ethics approval [12]

Approval date [12]

Ethics approval number [12]

Ethics committee name [13]

Albury

Ethics committee address [13]

Ethics committee country [13]

Australia

Date submitted for ethics approval [13]

Approval date [13]

Ethics approval number [13]

Ethics committee name [14]

WP Holman Clinic Launceston

Ethics committee address [14]

Ethics committee country [14]

Australia

Date submitted for ethics approval [14]

Approval date [14]

Ethics approval number [14]

Ethics committee name [15]

Queen Elizabeth

Ethics committee address [15]

Ethics committee country [15]

Australia

Date submitted for ethics approval [15]

Approval date [15]

Ethics approval number [15]

Ethics committee name [16]

Royal North Shore

Ethics committee address [16]

Ethics committee country [16]

Australia

Date submitted for ethics approval [16]

Approval date [16]

Ethics approval number [16]

Ethics committee name [17]

Royal Adelaide

Ethics committee address [17]

Ethics committee country [17]

Australia

Date submitted for ethics approval [17]

Approval date [17]

Ethics approval number [17]

Ethics committee name [18]

Royal Brisbane

Ethics committee address [18]

Ethics committee country [18]

Australia

Date submitted for ethics approval [18]

Approval date [18]

Ethics approval number [18]

Ethics committee name [19]

Bendigo Base

Ethics committee address [19]

Ethics committee country [19]

Australia

Date submitted for ethics approval [19]

Approval date [19]

Ethics approval number [19]

Ethics committee name [20]

Murray Valley Private

Ethics committee address [20]

Ethics committee country [20]

Australia

Date submitted for ethics approval [20]

Approval date [20]

Ethics approval number [20]

Ethics committee name [21]

Concord

Ethics committee address [21]

Ethics committee country [21]

Australia

Date submitted for ethics approval [21]

Approval date [21]

Ethics approval number [21]

Ethics committee name [22]

The Alfred

Ethics committee address [22]

Ethics committee country [22]

Australia

Date submitted for ethics approval [22]

Approval date [22]

Ethics approval number [22]

Summary

Brief summary

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Burcu Cakir

Address

NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450

Country

Australia

Phone

+61 2 95625334

Fax

+61 2 95625094

[email protected]

Contact person for scientific queries

Name

Dr Guy Toner

Address

Medical Oncology Unit
Peter MacCallum Cancer Institute
Locked Bag 1
A'Beckett Street
VIC 3000

Country

Australia

Phone

+61 3 96561804

Fax

+61 3 96561408

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Comparison of Two Standard Chemotherapy Regimens for Good-Prognosis Germ Cell Tumors: Updated Analysis of a Randomized Trial	2010	https://doi.org/10.1093/jnci/djq245

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically