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Trial registered on ANZCTR


Registration number
ACTRN12607000146493
Ethics application status
Approved
Date submitted
21/02/2007
Date registered
26/02/2007
Date last updated
14/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Post-Operative Concurrent Chemo-Radiotherapy Versus Post-Operative Radiotherapy for Cancer of the Head and Neck
Scientific title
Trans Tasman Radiation Oncology Group (TROG) 05.01 - Post-Operative Concurrent Chemo-Radiotherapy (Carboplatin) Versus Post-Operative Radiotherapy in High-Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck to improve loco-regional relapse
Secondary ID [1] 346 0
ClinicalTrials.gov ID NCT00193895
Universal Trial Number (UTN)
Trial acronym
TROG 05.01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma of the Head & Neck (Skin Cancer) 1640 0
Condition category
Condition code
Cancer 1750 1750 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 2: Radiotherapy 60Gy or 66Gy in 30-33 fractions, 5 times a week, over 5-5.5 weeks. Plus, Carboplatin intravenously weekly on either day 1, 2 or 3 of radiation with a max of six doses. Dose of carboplatin is calcualted by a formula that changes the value for each patient. Formula is glomerular filtration rate + 25 x target area under the concentration curve (AUC).
Intervention code [1] 1483 0
Treatment: Drugs
Comparator / control treatment
Arm 1: Radiotherapy alone 60Gy or 66Gy in 30-33 fractions, 5/week over 5 weeks
Control group
Active

Outcomes
Primary outcome [1] 2439 0
Loco-regional relapse - Time to loco-regional relapse from the date of randomisation.
Timepoint [1] 2439 0
Follow up visits are scheduled at 4, 8 and 12 weeks, then 6, 9, 12, 16, 20 and 24 months from completion of treatment and then 6 monthly intervals until the final patient has reached a minimum of 2 years follow up.
Secondary outcome [1] 4207 0
Disease free survival
Timepoint [1] 4207 0
Time from randomisation to the first relapse of any type. Follow up visits are scheduled at 4, 8 and 12 weeks, then 6, 9, 12, 16, 20 and 24 months from completion of treatment and then 6 monthly intervals until the final patient has reached a minimum of 2 years follow up.
Secondary outcome [2] 4208 0
Overall survival
Timepoint [2] 4208 0
Time from randomisation till death from any cause. Follow up visits are scheduled at 4, 8 and 12 weeks, then 6, 9, 12, 16, 20 and 24 months from completion of treatment and then 6 monthly intervals until the final patient has reached a minimum of 2 years follow up.
Secondary outcome [3] 4209 0
Quality of life
Timepoint [3] 4209 0
Assessments will be carried out pre-randomisation and the 12 weeks, 6, 12 and 24 months following completion of treatment and annually until the final patient has reached a minimum of 2 years follow up.
Secondary outcome [4] 4210 0
Treatment related late effects
Timepoint [4] 4210 0
Treatment related acute and late toxicity will be monitored using Common Terminology Criteria Adverse Events v3.0. Follow up visits are scheduled at 4, 8 and 12 weeks, then 6, 9, 12, 16, 20 and 24 months from completion of treatment and then 6 monthly intervals until the final patient has reached a minimum of 2 years follow up.

Eligibility
Key inclusion criteria
1. Histologically proven Squamous Cell Carcinoma
2. Complete macroscpoic resection of all known disease with or withour microscpoic positive margins. Surgery may consist of one or more of the following:a)Resection of the primary lesion; b) Any type of parotidectomy (superficial, total, partial, etc.); c) Any type of neck dissection(s)
3. High risk feature(s); high risk nodal disease and/or advanced primary disease: a) High Risk Nodal Disease
Intra-parotid nodal disease (any number or size, with/without extracapsular extension, with/without an identifiable index lesion)
b) Cervical nodal disease with a synchronous index lesion or previously resected cutaneous primary tumour (<5 years) within the corresponding nodal drainage and a mucosal primary has been excluded with at least a Computed Tomography (CT) +/- Magnetic Resonance Imaging (MRI) and panendoscopy*
* For cervical nodal disease to be eligible there must be at least one of the following
criteria:
(i) > 2 nodes
(ii) largest node > 3cm
(iii) Extracapsular extension
c) Advanced Primary Disease (Tumor, Node, Metastasis (TNM) 6th Edition 2002) (Appendix 1)
T3-4 primary disease (cartilage, skeletal, muscle, bone involvement, >4cm) of the
head and neck including lip, nose and external auditory canal with or without nodal
disease
d) In transit metastases (metastases between the primary site and the adjoining nodal basin)
4. Age >18 years
5. Written informed consent
6. Eastern Cooperative Oncology Group (ECOG) < 2
7. Absolute neutrophil count > 1.5 X 109/L, platelet count > 100 X 109/L, and haemoglobin > 10g/dL (pre-radiotherapy blood transfusion to elevate the haemoglobin > 10g/dL is permissible)
8. Calculated creatinine clearance (Cockcroft-Gault) >40mL/min
9. Available for follow-up for up to 5 years
10. Life expectancy greater than 6 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Intercurrent illness that will interfere with either the chemotherapy or radiotherapy
such as immunosuppression due to medication or medical condition
2. Metastasis(es) below the clavicle
3. Previous radical radiotherapy to the head and neck, excluding treatment of an early glottic cancer > 2 years ago and superficial radiotherapy to cutaneous Squamous Cell Carcinoma (SCC) or basal cell carcinoma
4. High risk for poor compliance with therapy or follow-up as assessed by investigator
5. Pregnant or lactating women
6. Patients with prior cancers, except: those diagnosed > 5 years ago with no evidence of disease recurrence and clinical expectation of recurrence of less than 5%; or
successfully treated Level 1 cutaneous melanomas or early glottic cancer > 2 years
ago; or non-melanoma skin cancer; or carcinoma in situ of the cervix.
7. Low risk cervical nodal disease* without advanced primary disease
*Low risk cervical nodal disease is defined as the presence of all of the following
criteria;
(i) single nodal metastasis,
(ii) < 3 cm,
(iii) no extracapsular extension.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation. Factors: high risk nodal metastases vs advanced primary disease, institution. Simple randomisation by computer.
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
Completed
Date of first participant enrolment
Anticipated
20/04/2005
Actual
20/04/2005
Date of last participant enrolment
Anticipated
Actual
13/10/2014
Date of last data collection
Anticipated
Actual
31/03/2016
Sample size
Target
350
Accrual to date
Final
321
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 1407 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 1408 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [3] 1409 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [4] 1410 0
Westmead Hospital - Westmead
Recruitment hospital [5] 1411 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [6] 1412 0
The Townsville Hospital - Douglas
Recruitment hospital [7] 1413 0
St Andrew's Toowoomba Hospital - Toowoomba
Recruitment hospital [8] 1414 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [9] 1415 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [10] 1416 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [11] 1417 0
The Alfred - Prahran
Recruitment hospital [12] 1418 0
Liverpool Hospital - Liverpool
Recruitment hospital [13] 1419 0
Illawarra Private Cancer Care & Research Centre - Wollongong
Recruitment hospital [14] 1420 0
Riverina Cancer Care Centre - Wagga Wagga
Recruitment hospital [15] 1421 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [16] 5132 0
St Vincents Private Hospital Lismore - Lismore
Recruitment hospital [17] 5133 0
John Flynn - Gold Coast Private Hospital - Tugun
Recruitment postcode(s) [1] 12597 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 5278 0
New Zealand
State/province [1] 5278 0
Auckland
Country [2] 5279 0
New Zealand
State/province [2] 5279 0
Waikato
Country [3] 5280 0
New Zealand
State/province [3] 5280 0
Christchurch
Country [4] 5281 0
New Zealand
State/province [4] 5281 0
Palmerston North

Funding & Sponsors
Funding source category [1] 1898 0
Charities/Societies/Foundations
Name [1] 1898 0
Queensland Cancer Fund
Country [1] 1898 0
Australia
Funding source category [2] 1899 0
Other Collaborative groups
Name [2] 1899 0
Royal Australian and New Zealand College of Radiologists
Country [2] 1899 0
Australia
Funding source category [3] 1900 0
Hospital
Name [3] 1900 0
Princess Alexandra Hospital
Country [3] 1900 0
Australia
Funding source category [4] 1901 0
Government body
Name [4] 1901 0
Health research council
Country [4] 1901 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
Trans Tasman Radiation Oncology Group (TROG)
Address
Edith ST
Waratah
NSW
2298
Country
Australia
Secondary sponsor category [1] 289939 0
None
Name [1] 289939 0
Address [1] 289939 0
Country [1] 289939 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3532 0
Auckland Hospital
Ethics committee address [1] 3532 0
Ethics committee country [1] 3532 0
New Zealand
Date submitted for ethics approval [1] 3532 0
Approval date [1] 3532 0
12/01/2005
Ethics approval number [1] 3532 0
Ethics committee name [2] 3533 0
Christchurch Hospital
Ethics committee address [2] 3533 0
Ethics committee country [2] 3533 0
New Zealand
Date submitted for ethics approval [2] 3533 0
Approval date [2] 3533 0
Ethics approval number [2] 3533 0
Ethics committee name [3] 3534 0
Geelong Hospital
Ethics committee address [3] 3534 0
Ethics committee country [3] 3534 0
Australia
Date submitted for ethics approval [3] 3534 0
Approval date [3] 3534 0
Ethics approval number [3] 3534 0
Ethics committee name [4] 3535 0
Premion Tugun - John Flynn Cancer Centre
Ethics committee address [4] 3535 0
Ethics committee country [4] 3535 0
Australia
Date submitted for ethics approval [4] 3535 0
Approval date [4] 3535 0
Ethics approval number [4] 3535 0
Ethics committee name [5] 3536 0
Liverpool Hospital
Ethics committee address [5] 3536 0
Ethics committee country [5] 3536 0
Australia
Date submitted for ethics approval [5] 3536 0
Approval date [5] 3536 0
Ethics approval number [5] 3536 0
Ethics committee name [6] 3537 0
Mater QRI
Ethics committee address [6] 3537 0
Ethics committee country [6] 3537 0
Australia
Date submitted for ethics approval [6] 3537 0
Approval date [6] 3537 0
Ethics approval number [6] 3537 0
Ethics committee name [7] 3538 0
Calvary Mater Newcastle
Ethics committee address [7] 3538 0
Ethics committee country [7] 3538 0
Australia
Date submitted for ethics approval [7] 3538 0
Approval date [7] 3538 0
Ethics approval number [7] 3538 0
Ethics committee name [8] 3539 0
Peter MacCallum Cancer Centre
Ethics committee address [8] 3539 0
Ethics committee country [8] 3539 0
Australia
Date submitted for ethics approval [8] 3539 0
Approval date [8] 3539 0
Ethics approval number [8] 3539 0
Ethics committee name [9] 3540 0
Palmerston North
Ethics committee address [9] 3540 0
Ethics committee country [9] 3540 0
Australia
Date submitted for ethics approval [9] 3540 0
Approval date [9] 3540 0
Ethics approval number [9] 3540 0
Ethics committee name [10] 3541 0
Princess Alexandra Hospital
Ethics committee address [10] 3541 0
Ethics committee country [10] 3541 0
Australia
Date submitted for ethics approval [10] 3541 0
Approval date [10] 3541 0
Ethics approval number [10] 3541 0
Ethics committee name [11] 3542 0
Royal Adelaide Hospital
Ethics committee address [11] 3542 0
Ethics committee country [11] 3542 0
Australia
Date submitted for ethics approval [11] 3542 0
Approval date [11] 3542 0
Ethics approval number [11] 3542 0
Ethics committee name [12] 3543 0
Royal Brisbane and Women's Hospital
Ethics committee address [12] 3543 0
Ethics committee country [12] 3543 0
Australia
Date submitted for ethics approval [12] 3543 0
Approval date [12] 3543 0
Ethics approval number [12] 3543 0
Ethics committee name [13] 3544 0
Royal Prince Alfred Hospital
Ethics committee address [13] 3544 0
Ethics committee country [13] 3544 0
Australia
Date submitted for ethics approval [13] 3544 0
Approval date [13] 3544 0
Ethics approval number [13] 3544 0
Ethics committee name [14] 3545 0
Townsville Hospital
Ethics committee address [14] 3545 0
Ethics committee country [14] 3545 0
Australia
Date submitted for ethics approval [14] 3545 0
Approval date [14] 3545 0
Ethics approval number [14] 3545 0
Ethics committee name [15] 3546 0
Waikato Hospital
Ethics committee address [15] 3546 0
Ethics committee country [15] 3546 0
New Zealand
Date submitted for ethics approval [15] 3546 0
Approval date [15] 3546 0
Ethics approval number [15] 3546 0
Ethics committee name [16] 3547 0
Westmead Hospital
Ethics committee address [16] 3547 0
Ethics committee country [16] 3547 0
Australia
Date submitted for ethics approval [16] 3547 0
Approval date [16] 3547 0
Ethics approval number [16] 3547 0
Ethics committee name [17] 7003 0
St Vincent's Hospital
Ethics committee address [17] 7003 0
Ethics committee country [17] 7003 0
Australia
Date submitted for ethics approval [17] 7003 0
Approval date [17] 7003 0
Ethics approval number [17] 7003 0
Ethics committee name [18] 7004 0
Royal North Shore Hospital
Ethics committee address [18] 7004 0
Ethics committee country [18] 7004 0
Australia
Date submitted for ethics approval [18] 7004 0
Approval date [18] 7004 0
Ethics approval number [18] 7004 0
Ethics committee name [19] 7005 0
St Andrew's Cancer Care, Toowoomba Hospital
Ethics committee address [19] 7005 0
Ethics committee country [19] 7005 0
Australia
Date submitted for ethics approval [19] 7005 0
Approval date [19] 7005 0
Ethics approval number [19] 7005 0
Ethics committee name [20] 7006 0
Riverina Cancer Care Centre
Ethics committee address [20] 7006 0
Ethics committee country [20] 7006 0
Australia
Date submitted for ethics approval [20] 7006 0
Approval date [20] 7006 0
Ethics approval number [20] 7006 0
Ethics committee name [21] 7007 0
William Buckland Radiotherapy Centre, The Alfred
Ethics committee address [21] 7007 0
Ethics committee country [21] 7007 0
Australia
Date submitted for ethics approval [21] 7007 0
Approval date [21] 7007 0
Ethics approval number [21] 7007 0

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

Contacts
Principal investigator
Name 27417 0
Prof Sandro Porceddu
Address 27417 0
Princess Alexandra Hospital Oncology Services
Ipswich Road
Woolloongabba QLD 4102
Country 27417 0
Australia
Phone 27417 0
+61 7 3176 7853
Fax 27417 0
+61 7 3176 1983
Email 27417 0
Sandro.Porceddu@health.qld.gov.au
Contact person for public queries
Name 10672 0
Sandro Porceddu
Address 10672 0
Princess Alexandra Hospital
Oncology Services
Ipswich Road
Woolloongabba QLD 4102
Country 10672 0
Australia
Phone 10672 0
+61 7 3176 7853
Fax 10672 0
+61 7 3176 1983
Email 10672 0
Sandro.Porceddu@health.qld.gov.au
Contact person for scientific queries
Name 1600 0
Sandro Porceddu
Address 1600 0
Princess Alexandra Hospital
Oncology Services
Ipswich Road
Woolloongabba QLD 4102
Country 1600 0
Australia
Phone 1600 0
+61 7 3176 7853
Fax 1600 0
+61 7 3176 1983
Email 1600 0
Sandro.Porceddu@health.qld.gov.au

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