Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000509662
Ethics application status
Approved
Date submitted
15/09/2005
Date registered
26/09/2005
Date last updated
26/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Gemcitabine and carboplatin induction chemotherapy followed by concurrent cisplatin and IMRT for locally advanced nasopharyngeal cancer
Scientific title
Gemcitabine and carboplatin induction chemotherapy followed by concurrent cisplatin and IMRT for locally advanced nasopharyngeal cancer
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally advanced nasopharyngeal cancer 634 0
Condition category
Condition code
Cancer 706 706 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Induction chemotherapy for 9 weeks followed by concurrent chemoradiation for 7 weeks.
Intervention code [1] 617 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 859 0
Safety
Timepoint [1] 859 0
Primary outcome [2] 860 0
Feasibility
Timepoint [2] 860 0
Secondary outcome [1] 1723 0
Failure-free survival
Timepoint [1] 1723 0
Secondary outcome [2] 1724 0
Overall survival
Timepoint [2] 1724 0
Secondary outcome [3] 1725 0
Site of first failure
Timepoint [3] 1725 0

Eligibility
Key inclusion criteria
WHO types 2 and 3 nasopharyngeal cancer; T3-4 and/or N1 > 3 cm, N2-3; no prior malignancies, no prior chemotherapy or radiation
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 783 0
Self funded/Unfunded
Name [1] 783 0
Country [1] 783 0
Primary sponsor type
Charities/Societies/Foundations
Name
Peter MacCallum Cancer Centre
Address
Country
Australia
Secondary sponsor category [1] 647 0
None
Name [1] 647 0
nil
Address [1] 647 0
Country [1] 647 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2061 0
Peter MacCallum
Ethics committee address [1] 2061 0
Ethics committee country [1] 2061 0
Australia
Date submitted for ethics approval [1] 2061 0
Approval date [1] 2061 0
Ethics approval number [1] 2061 0

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

Contacts
Principal investigator
Name 36312 0
Address 36312 0
Country 36312 0
Phone 36312 0
Fax 36312 0
Email 36312 0
Contact person for public queries
Name 9806 0
Danny Rischin
Address 9806 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Country 9806 0
Australia
Phone 9806 0
+61 3 96561804
Fax 9806 0
Email 9806 0
[email protected]
Contact person for scientific queries
Name 734 0
Ruth Hutson
Address 734 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Country 734 0
Australia
Phone 734 0
+61 3 96561111
Fax 734 0
Email 734 0
[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
No additional documents have been identified.