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Trial registered on ANZCTR


Registration number
ACTRN12605000768695
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
29/11/2005
Date last updated
28/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
COSA Head and Neck Study
Scientific title
A Randomised Comparative Study of
Surgery Versus Radiotherapy and Chemotherapy in Patients With Squamous Cell Carcinoma of the Head & Neck
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Histologically confirmed SCC of oral cavity, pharynx, hypopharynx and larynx. 924 0
Condition category
Condition code
Cancer 991 991 0 0
Head and neck
Surgery 992 992 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Surgery, chemotherapy, radiation therapy.
Patients randomised to surgery will proceed to their planned surgery within three weeks of radiotherapy. Post operative radiotherapy may be given if indicated. Patients randomised to chemotherapy will be given chemotherapy by intravenous infusion for 4 days, repeated at 21 day intervals. Radiotherapy will commence following the 3rd course of chemotherapy. If required surgery will be conducted at this time. Chemotherapy will then be given simultaneously with the radiotherapy and an additional chemotherapy will be given after the radiotherapy.
Intervention code [1] 561 0
Treatment: Other
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1317 0
Time to progression
Timepoint [1] 1317 0
Assessments will be 9 weeks following surgery and then every 3 months for 1 year. For patients receiving chemotherapy and radiotherapy assessments will be made on day 1 of each chemotherapy cycle, after 3 cycles and then 3 monthly for the first year. After the first year all patients will be followed up on a 6 month basis.
Primary outcome [2] 1318 0
Objective response rate
Timepoint [2] 1318 0
Assessments will be 9 weeks following surgery and then every 3 months for 1 year. For patients receiving chemotherapy and radiotherapy assessments will be made on day 1 of each chemotherapy cycle, after 3 cycles and then 3 monthly for the first year. After the first year all patients will be followed up on a 6 month basis.
Primary outcome [3] 1319 0
Overall survival
Timepoint [3] 1319 0
Assessments will be 9 weeks following surgery and then every 3 months for 1 year. For patients receiving chemotherapy and radiotherapy assessments will be made on day 1 of each chemotherapy cycle, after 3 cycles and then 3 monthly for the first year. After the first year all patients will be followed up on a 6 month basis.
Secondary outcome [1] 2359 0
Toxicity.
Timepoint [1] 2359 0
Blood counts for haematological toxicity and serum creatinine for renal toxicity will be measured on day 1 of each chemotherapy cycle after 3 cycles and then 3 monthly for the first year.

Eligibility
Key inclusion criteria
Histologically confirmed SCC of oral cavity, pharynx, hypopharynx and larynx.Patients planned to receive surgery which would result in significant deformity or disfiguration or significant loss of function. "Significant" will be left to the discretion of the investigators.No prior chemotherapy, radiotherapy or surgery ( other than biopsy).Documentation of measurable disease(see section).ECOG performance status of 2 or better.Geographically assessable for treatment follow up.Adequate bone marrow reserves with WBC >3.9 and platelets > 100.Adequate renal and hepatic function with creatinine < 0.13mmol/L or creatinine clearance >0.8ml/sec and liver function test < 1.5 x the upper limit of normal.Be able to complete quality of life assessment.Have given informed consent.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Past or current malignancies at other sites except adequately treated squamous or basal cell carcinoma of the skin or in-situ carcinoma of the cervix.Metastatic tumour (outside local area and its draining/regional nodes).No upper age limit is specified; entry will be at the discretion of the investigator.Tumours originating in the skin are not eligible.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was done through permuted blocks at a central location. Stratification was performed at the time of randomisation based on: i) treating institution ii) site of primary iii) nodal status iv) ECOG performance status.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 1088 0
Charities/Societies/Foundations
Name [1] 1088 0
NSW Cancer Council Program Grant
Address [1] 1088 0
Country [1] 1088 0
Australia
Primary sponsor type
Individual
Name
Investigator Initiated. Study Chairman: Dr David Dalley from St Vincents Hospital NSW. Co-ordinating Centre: Clinical Trials Centre, University of Sydney.
Address
Country
Australia
Secondary sponsor category [1] 949 0
Government body
Name [1] 949 0
NHMRC CTC
Address [1] 949 0
Country [1] 949 0
Australia
Secondary sponsor category [2] 950 0
Charities/Societies/Foundations
Name [2] 950 0
COSA
Address [2] 950 0
Country [2] 950 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36281 0
Address 36281 0
Country 36281 0
Phone 36281 0
Fax 36281 0
Email 36281 0
Contact person for public queries
Name 9750 0
Burcu Cakir
Address 9750 0
National Health and Medical Research Council (NHMRC) Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 9750 0
Australia
Phone 9750 0
+61 2 95625334
Fax 9750 0
+61 2 95625094
Email 9750 0
bcakir@ctc.usyd.edu.au
Contact person for scientific queries
Name 678 0
David Dalley
Address 678 0
Department of Medical Oncology
St Vincent's Hospital
Darlinghurst NSW 2010
Country 678 0
Australia
Phone 678 0
+61 2 95625334
Fax 678 0
Email 678 0
drdalley@stvincents.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary