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
ACTRN12605000114640
Ethics application status
Approved
Date submitted
5/08/2005
Date registered
9/08/2005
Date last updated
25/10/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hypofractionated radiotherapy for the palliation of patients with advanced head and neck cancer who are unsuitable for an attempt at curative treatment
Scientific title
Assessment of quality of life of patients undergoing hypofractionated radiotherapy for the palliation of patients with advanced head and neck cancer who are unsuitable for an attempt at curative treatment
Secondary ID [1] 107 0
Hypofractionated head and neck study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced head and neck cancer 202 0
Condition category
Condition code
Cancer 225 225 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hypofractionated radiotherapy, 30 Gray in 5 fractions, optional 6th 5 Gray fraction.
Intervention code [1] 123 0
Treatment: Other
Comparator / control treatment
None - single arm study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 273 0
Quality of life
Timepoint [1] 273 0
Assessed at baseline, 1, 2, 3, 6, 9 and 12 months post treatment.
Secondary outcome [1] 610 0
Analgesic requirements and radiation toxicity
Timepoint [1] 610 0
Assessed at baseline, weekly during treatment and at 1, 2, 3, 6, 9 and 12 months post treatment.
Secondary outcome [2] 611 0
Local control
Timepoint [2] 611 0
Assessed at 1, 2, 3, 6, 9 & 12 months post treatment.
Secondary outcome [3] 612 0
Survival
Timepoint [3] 612 0
Assessed up to 12 months post treatment.

Eligibility
Key inclusion criteria
Biopsy proven squamus cell carcinoma (primary or regional nodal disease) of the head and neck, ineligible for curative treatment, performance status 0-2, life expectanccy of at least 4 months, written informed consent.
Minimum age
Not stated
Maximum age
No limit
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 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/08/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 287 0
Self funded/Unfunded
Name [1] 287 0
Country [1] 287 0
Primary sponsor type
Individual
Name
Dr Sandro Porceddu
Address
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 218 0
None
Name [1] 218 0
none
Address [1] 218 0
Country [1] 218 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1139 0
Southern Zone Radiation Oncology Service-Pricness Alexandra Hospital
Ethics committee address [1] 1139 0
Ethics committee country [1] 1139 0
Australia
Date submitted for ethics approval [1] 1139 0
Approval date [1] 1139 0
Ethics approval number [1] 1139 0
Ethics committee name [2] 1140 0
Southern Zone Radiation Oncology Service-Mater Hospital,South Brisbane
Ethics committee address [2] 1140 0
Ethics committee country [2] 1140 0
Australia
Date submitted for ethics approval [2] 1140 0
Approval date [2] 1140 0
Ethics approval number [2] 1140 0
Ethics committee name [3] 1141 0
The Townsville Hospital
Ethics committee address [3] 1141 0
Ethics committee country [3] 1141 0
Australia
Date submitted for ethics approval [3] 1141 0
Approval date [3] 1141 0
Ethics approval number [3] 1141 0

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

Contacts
Principal investigator
Name 35798 0
Address 35798 0
Country 35798 0
Phone 35798 0
Fax 35798 0
Email 35798 0
Contact person for public queries
Name 9312 0
Dr Sandro Porceddu
Address 9312 0
Radiation Oncology
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba QLD 4102
Country 9312 0
Australia
Phone 9312 0
+61 7 32405279
Fax 9312 0
+61 7 32402252
Email 9312 0
[email protected]
Contact person for scientific queries
Name 240 0
Brenda Rosser
Address 240 0
Oncology Research Unit
Delivery Point 35
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba Brisbane QLD 4102
Country 240 0
Australia
Phone 240 0
+61 7 32402130
Fax 240 0
+61 7 32402252
Email 240 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.