Trial Review

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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. 232 0
Condition category
Condition code
Cancer 263 263 0 0
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] 140 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 308 0
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] 308 0
Primary outcome [2] 309 0
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] 309 0
Primary outcome [3] 310 0
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] 310 0
Primary outcome [4] 311 0
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] 311 0
Primary outcome [5] 312 0
To assess the quality of life of patients receiving each of the chemotherapy regimens.
Timepoint [5] 312 0
Secondary outcome [1] 694 0
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] 694 0
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?
No
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] 318 0
Government body
Name [1] 318 0
NHMRC
Country [1] 318 0
Australia
Funding source category [2] 319 0
Charities/Societies/Foundations
Name [2] 319 0
NSW Cancer Council
Country [2] 319 0
Australia
Funding source category [3] 320 0
Charities/Societies/Foundations
Name [3] 320 0
donation from Apex Foundationand Apex Clubs of Australia
Country [3] 320 0
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] 248 0
Charities/Societies/Foundations
Name [1] 248 0
NSW Cancer Council and Apex
Address [1] 248 0
Country [1] 248 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1207 0
Princess Alexandra
Ethics committee address [1] 1207 0
Ethics committee country [1] 1207 0
Australia
Date submitted for ethics approval [1] 1207 0
Approval date [1] 1207 0
Ethics approval number [1] 1207 0
Ethics committee name [2] 1208 0
Peter MacCallum Cancer Insitute
Ethics committee address [2] 1208 0
Ethics committee country [2] 1208 0
Australia
Date submitted for ethics approval [2] 1208 0
Approval date [2] 1208 0
Ethics approval number [2] 1208 0
Ethics committee name [3] 1209 0
Royal Prince alfred
Ethics committee address [3] 1209 0
Ethics committee country [3] 1209 0
Australia
Date submitted for ethics approval [3] 1209 0
Approval date [3] 1209 0
Ethics approval number [3] 1209 0
Ethics committee name [4] 1210 0
Liverpool
Ethics committee address [4] 1210 0
Ethics committee country [4] 1210 0
Australia
Date submitted for ethics approval [4] 1210 0
Approval date [4] 1210 0
Ethics approval number [4] 1210 0
Ethics committee name [5] 1211 0
Westmead
Ethics committee address [5] 1211 0
Ethics committee country [5] 1211 0
Australia
Date submitted for ethics approval [5] 1211 0
Approval date [5] 1211 0
Ethics approval number [5] 1211 0
Ethics committee name [6] 1212 0
Geelong
Ethics committee address [6] 1212 0
Ethics committee country [6] 1212 0
Australia
Date submitted for ethics approval [6] 1212 0
Approval date [6] 1212 0
Ethics approval number [6] 1212 0
Ethics committee name [7] 1213 0
Newcastle Mater Misericordiae
Ethics committee address [7] 1213 0
Ethics committee country [7] 1213 0
Australia
Date submitted for ethics approval [7] 1213 0
Approval date [7] 1213 0
Ethics approval number [7] 1213 0
Ethics committee name [8] 1214 0
Prince of Wales
Ethics committee address [8] 1214 0
Ethics committee country [8] 1214 0
Australia
Date submitted for ethics approval [8] 1214 0
Approval date [8] 1214 0
Ethics approval number [8] 1214 0
Ethics committee name [9] 1215 0
St Vincents
Ethics committee address [9] 1215 0
Ethics committee country [9] 1215 0
Australia
Date submitted for ethics approval [9] 1215 0
Approval date [9] 1215 0
Ethics approval number [9] 1215 0
Ethics committee name [10] 1216 0
The Canberra Hospital
Ethics committee address [10] 1216 0
VIC
Ethics committee country [10] 1216 0
Australia
Date submitted for ethics approval [10] 1216 0
Approval date [10] 1216 0
Ethics approval number [10] 1216 0
Ethics committee name [11] 1217 0
Royal perth
Ethics committee address [11] 1217 0
Ethics committee country [11] 1217 0
Australia
Date submitted for ethics approval [11] 1217 0
Approval date [11] 1217 0
Ethics approval number [11] 1217 0
Ethics committee name [12] 1218 0
Royal Hobart
Ethics committee address [12] 1218 0
Ethics committee country [12] 1218 0
Australia
Date submitted for ethics approval [12] 1218 0
Approval date [12] 1218 0
Ethics approval number [12] 1218 0
Ethics committee name [13] 1219 0
Albury
Ethics committee address [13] 1219 0
Ethics committee country [13] 1219 0
Australia
Date submitted for ethics approval [13] 1219 0
Approval date [13] 1219 0
Ethics approval number [13] 1219 0
Ethics committee name [14] 1220 0
WP Holman Clinic Launceston
Ethics committee address [14] 1220 0
Ethics committee country [14] 1220 0
Australia
Date submitted for ethics approval [14] 1220 0
Approval date [14] 1220 0
Ethics approval number [14] 1220 0
Ethics committee name [15] 1221 0
Queen Elizabeth
Ethics committee address [15] 1221 0
Ethics committee country [15] 1221 0
Australia
Date submitted for ethics approval [15] 1221 0
Approval date [15] 1221 0
Ethics approval number [15] 1221 0
Ethics committee name [16] 1222 0
Royal North Shore
Ethics committee address [16] 1222 0
Ethics committee country [16] 1222 0
Australia
Date submitted for ethics approval [16] 1222 0
Approval date [16] 1222 0
Ethics approval number [16] 1222 0
Ethics committee name [17] 1223 0
Royal Adelaide
Ethics committee address [17] 1223 0
Ethics committee country [17] 1223 0
Australia
Date submitted for ethics approval [17] 1223 0
Approval date [17] 1223 0
Ethics approval number [17] 1223 0
Ethics committee name [18] 1224 0
Royal Brisbane
Ethics committee address [18] 1224 0
Ethics committee country [18] 1224 0
Australia
Date submitted for ethics approval [18] 1224 0
Approval date [18] 1224 0
Ethics approval number [18] 1224 0
Ethics committee name [19] 1225 0
Bendigo Base
Ethics committee address [19] 1225 0
Ethics committee country [19] 1225 0
Australia
Date submitted for ethics approval [19] 1225 0
Approval date [19] 1225 0
Ethics approval number [19] 1225 0
Ethics committee name [20] 1226 0
Murray Valley Private
Ethics committee address [20] 1226 0
Ethics committee country [20] 1226 0
Australia
Date submitted for ethics approval [20] 1226 0
Approval date [20] 1226 0
Ethics approval number [20] 1226 0
Ethics committee name [21] 1227 0
Concord
Ethics committee address [21] 1227 0
Ethics committee country [21] 1227 0
Australia
Date submitted for ethics approval [21] 1227 0
Approval date [21] 1227 0
Ethics approval number [21] 1227 0
Ethics committee name [22] 1228 0
The Alfred
Ethics committee address [22] 1228 0
Ethics committee country [22] 1228 0
Australia
Date submitted for ethics approval [22] 1228 0
Approval date [22] 1228 0
Ethics approval number [22] 1228 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35453 0
Address 35453 0
Country 35453 0
Phone 35453 0
Fax 35453 0
Email 35453 0
Contact person for public queries
Name 9329 0
Burcu Cakir
Address 9329 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 9329 0
Australia
Phone 9329 0
+61 2 95625334
Fax 9329 0
+61 2 95625094
Email 9329 0
bcakir@ctc.usyd.edu.au
Contact person for scientific queries
Name 257 0
Dr Guy Toner
Address 257 0
Medical Oncology Unit
Peter MacCallum Cancer Institute
Locked Bag 1
A'Beckett Street
VIC 3000
Country 257 0
Australia
Phone 257 0
+61 3 96561804
Fax 257 0
+61 3 96561408
Email 257 0
gtoner@petermac.unimelb.edu.au

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
SourceTitleYear of PublicationDOI
Dimensions AIComparison of Two Standard Chemotherapy Regimens for Good-Prognosis Germ Cell Tumors: Updated Analysis of a Randomized Trial2010https://doi.org/10.1093/jnci/djq245
N.B. These documents automatically identified may not have been verified by the study sponsor.