Trial Review

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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
ACTRN12605000510640
Ethics application status
Approved
Date submitted
15/09/2005
Date registered
26/09/2005
Date last updated
2/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase I/II trial to evaluate gefitinib and concurrent postoperative chemoradiation in patients with advanced resectable head and neck cancer
Scientific title
A Phase I/II trial to evaluate gefitinib and concurrent postoperative chemoradiation in patients with advanced resectable head and neck cancer
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and neck Cancer 635 0
Condition category
Condition code
Cancer 707 707 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Addition of gefitinib to chemoradiation; 2-4 weeks of gefitinib followed by 6 weeks chemoradiation + gefitinib
Intervention code [1] 615 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 861 0
Safety
Timepoint [1] 861 0
Primary outcome [2] 862 0
Feasibility
Timepoint [2] 862 0
Secondary outcome [1] 1726 0
Failure-free survival
Timepoint [1] 1726 0
Secondary outcome [2] 1727 0
Local-regional control
Timepoint [2] 1727 0
Secondary outcome [3] 1728 0
Overall survival
Timepoint [3] 1728 0

Eligibility
Key inclusion criteria
Resected SCC oral cavity, oropharynx, hypopharynx or larynx; risk factors for recurrence; no macroscopic residual disease, no prior radiotehrapy for head and neck cancer, no prior chemotherapy.
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
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 784 0
Commercial sector/Industry
Name [1] 784 0
Astra-Zeneca
Country [1] 784 0
Primary sponsor type
Charities/Societies/Foundations
Name
peter maccallum Cancer Centre
Address
Country
Australia
Secondary sponsor category [1] 648 0
None
Name [1] 648 0
nil
Address [1] 648 0
Country [1] 648 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2062 0
Peter MacCallum
Ethics committee address [1] 2062 0
Ethics committee country [1] 2062 0
Australia
Date submitted for ethics approval [1] 2062 0
Approval date [1] 2062 0
Ethics approval number [1] 2062 0

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

Contacts
Principal investigator
Name 35165 0
Address 35165 0
Country 35165 0
Phone 35165 0
Fax 35165 0
Email 35165 0
Contact person for public queries
Name 9804 0
Danny Rischin
Address 9804 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Country 9804 0
Australia
Phone 9804 0
+61 3 96561804
Fax 9804 0
Email 9804 0
Danny.Rischin@petermac.org
Contact person for scientific queries
Name 732 0
Ruth Hutson
Address 732 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Country 732 0
Australia
Phone 732 0
+61 3 96561111
Fax 732 0
Email 732 0
Ruth.Hutson@petermac.org

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.