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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ANZCTR
Last refreshed on:	13 January 2020
Main ID:	ACTRN12605000142639
Date of registration:	12/08/2005
Prospective Registration:	No
Primary sponsor:	Australian and New Zealand Germ Cell Trials Group at NHMRC Clinical Trials Centre
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.
Date of first enrolment:	05/01/1994
Target sample size:	260
Recruitment status:	Active, not recruiting
URL:	https://anzctr.org.au/ACTRN12605000142639.aspx
Study type:	Interventional
Study design:	Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
Phase:	Phase 3

Countries of recruitment
Australia

Contacts

Name:	Burcu Cakir
Address:	NHMRC Clinical Trials Centre Locked Bag 77 Camperdown NSW 1450 Australia
Telephone:	+61 2 95625334
Email:	bcakir@ctc.usyd.edu.au
Affiliation:

Name:	Dr Guy Toner
Address:	Medical Oncology Unit Peter MacCallum Cancer Institute Locked Bag 1 A'Beckett Street VIC 3000 Australia
Telephone:	+61 3 96561804
Email:	gtoner@petermac.unimelb.edu.au
Affiliation:

Key inclusion & exclusion criteria

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.
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.

Age minimum: Not stated
Age maximum: Not stated
Gender: Both males and females

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

Cancer - Testicular

Intervention(s)

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.

Primary Outcome(s)

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.[]

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.[]

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

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.[]

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.[]

Secondary Outcome(s)

To evaluate the value of measuring the rate of fall of alpha-fetoprotein and Human Chorionic Gonadotrophin as an early predictor of response.[Serum Tumour markers (aFP and HCG) were performed pre-study, weekly (while tumour marker is elevated), prior to each cycle and off study.]

Secondary ID(s)

Source(s) of Monetary Support

NSW Cancer Council

NHMRC

donation from Apex Foundationand Apex Clubs of Australia

Secondary Sponsor(s)

NSW Cancer Council and Apex

Ethics review