Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000064404
Ethics application status
Approved
Date submitted
28/07/2004
Date registered
28/07/2004
Date last updated
27/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A phase III international randomized trial of single versus multiple fractions for re-irradiation of painful bone metastases
Scientific title
Trans Tasman Radiation Oncology Group (TROG) 03.08 - A phase III international randomized trial of single versus multiple fractions for re-irradiation of painful bone metastases from any cancer to increase pain relief
Secondary ID [1] 57 0
National Clinical Trials Registry: NCTR579
Secondary ID [2] 58 0
Clinicaltrials.gov: NCT00080912
Universal Trial Number (UTN)
Trial acronym
TROG 03.08
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Painful bone metastates from any cancer after previous palliative radiotherapy. 53 0
Condition category
Condition code
Cancer 59 59 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 2: Multiple fractionation (20 Gy, 5 fractions - 4Gy x 5 daily fractions, eight fractions (for spine and/or whole pelvis only))
Intervention code [1] 1496 0
Treatment: Other
Comparator / control treatment
Arm 1: Single fractionation (8Gy, one fraction)
Control group
Dose comparison

Outcomes
Primary outcome [1] 93 0
Overall response rates
Timepoint [1] 93 0
At 2 months from the start of treatment
Secondary outcome [1] 183 0
1. Incidence of acute radiation related side effects
Timepoint [1] 183 0
Day 7 and 14 from the first fraction of radiation.
Secondary outcome [2] 184 0
2. Freedom from progression
Timepoint [2] 184 0
Measured at each follow up visit until progression. Follow up for every month for 6 months starting one month from the first day re-irrradiation, then at months 9 and 12.
Secondary outcome [3] 185 0
3. European Organisation for Research and Treatment for Cancer Qulaity of life questionnaire (EORTC QLQ-C30).
Timepoint [3] 185 0
Months 1, 2, 3, 4, 5 and 6 after radiation.

Eligibility
Key inclusion criteria
1. Patient must have histologically or cytologically proven malignancy. Histological diagnosis may be established from needle biopsy, bone marrow biopsy, cytology, or a surgical biopsy or resection. All malignant histologies/cytologies are eligible. 2. Plain radigraphs, radionuclide bone scans, CT scans and/or magnetic resonance imaging confirm the presence of bone metastatses corresponding to clinically painful area.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Clinical or radiological evidence of spinal cord compression at the time of assessment for this study.2. Clinical or radiological evidence of pathological fractures of extremities in the area to be re-irradiated.3. The treatment area has received prior palliative surgery.4. There is planned surgical intervention on the treated bone.

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 phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
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
3/09/2004
Actual
2/03/2004
Date of last participant enrolment
Anticipated
Actual
28/05/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
850
Accrual to date
Final
850
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 4759 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 4760 0
Westmead Private Hospital - Westmead
Recruitment hospital [3] 4761 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [4] 4762 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [5] 4763 0
Liverpool Hospital - Liverpool
Recruitment hospital [6] 4764 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [7] 4765 0
Wesley Hospital Kogarah - Kogarah
Recruitment hospital [8] 4766 0
The Alfred - Prahran
Recruitment hospital [9] 4767 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [10] 4768 0
Princess Alexandra Hospital - Woolloongabba
Recruitment outside Australia
Country [1] 5583 0
Canada
State/province [1] 5583 0
Country [2] 7383 0
New Zealand
State/province [2] 7383 0
Country [3] 7384 0
Singapore
State/province [3] 7384 0

Funding & Sponsors
Funding source category [1] 89 0
Government body
Name [1] 89 0
National Health & Medical Research Council Project Grant
Country [1] 89 0
Australia
Funding source category [2] 90 0
Government body
Name [2] 90 0
Multistate cancer council grant
Country [2] 90 0
Australia
Funding source category [3] 91 0
Commercial sector/Industry
Name [3] 91 0
Mayne Pharma
Country [3] 91 0
United Kingdom
Primary sponsor type
Other Collaborative groups
Name
National Cancer Insitute of Canada
Address
10 Alcorn Avenue, Suite 200
Toronto, Ontario M4V 3B1
Country
Canada
Secondary sponsor category [1] 69 0
Other Collaborative groups
Name [1] 69 0
Trans Tasman Radiation Oncology Group (TROG)
Address [1] 69 0
Edith St Waratah NSW 2298
Country [1] 69 0
Australia
Other collaborator category [1] 277694 0
Other Collaborative groups
Name [1] 277694 0
Radiation Therapy Oncology Group
Address [1] 277694 0
RTOG Headquarters
1818 Market Street, Suite 1600
Philadelphia, PA 19103
Country [1] 277694 0
United States of America
Other collaborator category [2] 277695 0
Other Collaborative groups
Name [2] 277695 0
Cancer Research UK
Address [2] 277695 0
Angel Building, 407 St John Street, London EC1V 4AD
Country [2] 277695 0
United Kingdom
Other collaborator category [3] 277696 0
Other Collaborative groups
Name [3] 277696 0
Assistance Publique - Hopitaux de Paris
Address [3] 277696 0
3 Victoria Avenue 75004 Paris
Country [3] 277696 0
France

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 594 0
Alfred Hospital
Ethics committee address [1] 594 0
Ethics committee country [1] 594 0
Australia
Date submitted for ethics approval [1] 594 0
Approval date [1] 594 0
Ethics approval number [1] 594 0
Ethics committee name [2] 595 0
Christchurch Hospital
Ethics committee address [2] 595 0
Ethics committee country [2] 595 0
New Zealand
Date submitted for ethics approval [2] 595 0
Approval date [2] 595 0
Ethics approval number [2] 595 0
Ethics committee name [3] 596 0
Liverpool Hospital
Ethics committee address [3] 596 0
Ethics committee country [3] 596 0
Australia
Date submitted for ethics approval [3] 596 0
Approval date [3] 596 0
Ethics approval number [3] 596 0
Ethics committee name [4] 597 0
Mater QRI
Ethics committee address [4] 597 0
Ethics committee country [4] 597 0
Australia
Date submitted for ethics approval [4] 597 0
Approval date [4] 597 0
11/11/2011
Ethics approval number [4] 597 0
Ethics committee name [5] 598 0
MacArthur Cancer Therapy Centre
Ethics committee address [5] 598 0
Ethics committee country [5] 598 0
Australia
Date submitted for ethics approval [5] 598 0
Approval date [5] 598 0
Ethics approval number [5] 598 0
Ethics committee name [6] 599 0
Newcastle Mater Hospital
Ethics committee address [6] 599 0
Ethics committee country [6] 599 0
Australia
Date submitted for ethics approval [6] 599 0
Approval date [6] 599 0
Ethics approval number [6] 599 0
Ethics committee name [7] 600 0
Peter MacCallum Cancer Centre
Ethics committee address [7] 600 0
Ethics committee country [7] 600 0
Australia
Date submitted for ethics approval [7] 600 0
Approval date [7] 600 0
Ethics approval number [7] 600 0
Ethics committee name [8] 601 0
Princess Alexandra Hospital
Ethics committee address [8] 601 0
Ethics committee country [8] 601 0
Australia
Date submitted for ethics approval [8] 601 0
Approval date [8] 601 0
Ethics approval number [8] 601 0
Ethics committee name [9] 602 0
Royal Adelaide Hospital
Ethics committee address [9] 602 0
Ethics committee country [9] 602 0
Australia
Date submitted for ethics approval [9] 602 0
Approval date [9] 602 0
Ethics approval number [9] 602 0
Ethics committee name [10] 603 0
Royal Brisbane Hospital
Ethics committee address [10] 603 0
Ethics committee country [10] 603 0
Australia
Date submitted for ethics approval [10] 603 0
Approval date [10] 603 0
Ethics approval number [10] 603 0
Ethics committee name [11] 604 0
Royal North Shore Hospital
Ethics committee address [11] 604 0
Ethics committee country [11] 604 0
Australia
Date submitted for ethics approval [11] 604 0
Approval date [11] 604 0
Ethics approval number [11] 604 0
Ethics committee name [12] 605 0
Royal Prince Alfred
Ethics committee address [12] 605 0
Ethics committee country [12] 605 0
Australia
Date submitted for ethics approval [12] 605 0
Approval date [12] 605 0
Ethics approval number [12] 605 0
Ethics committee name [13] 606 0
W.P Holman Clinic
Ethics committee address [13] 606 0
Ethics committee country [13] 606 0
Australia
Date submitted for ethics approval [13] 606 0
Approval date [13] 606 0
Ethics approval number [13] 606 0
Ethics committee name [14] 607 0
Wesley Radiation Oncology
Ethics committee address [14] 607 0
Ethics committee country [14] 607 0
Australia
Date submitted for ethics approval [14] 607 0
Approval date [14] 607 0
Ethics approval number [14] 607 0
Ethics committee name [15] 608 0
Westmead Hospital
Ethics committee address [15] 608 0
Ethics committee country [15] 608 0
Australia
Date submitted for ethics approval [15] 608 0
Approval date [15] 608 0
Ethics approval number [15] 608 0

Summary
Brief summary
Radiotherapy is an effective treatment for people with cancer that has spread to their bones and is causing problems. Sometimes, a second course of radiation is required. This international randomised trial will determine if it is better for a second course of radiation to be done as one large treatment, or as several smaller treatments.
Trial website
Trial related presentations / publications
Chow E, Hoskin P, Wuz J, Roos D, van der Linden Y, Hartsell W, Vieth R, Wilson C, Pater J. A Phase III International Randomised Trial Comparing Single with Multiple Fractions for Re-irradiation of Painful Bone Metastases: National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) SC 20. J Clin Oncol. 2006; 18 (2):125-128. (Editorial)

Roos D. Response to “Determining the incidence of pain flare following palliative radiotherapy for symptomatic bone metastases: results from three Canadian centers”. Int J Rad Onc Biol Phys. 2010; 78 (2): 637-637.

Chow E, van der Linden Y, Roos DE, Hartsell WF, Hoskin P, Wu Jackson S, Brundage M, Nabid A, Tissing-Tan C, Oei B, Babington S, Demas W, Wilson F, Meyer R, Chen B, Wong R. Single versus multiple fractions of repeat radiation for painful bone metastases: a randomised, controlled, non-inferiority trial. Lancet Oncol, 2014 Feb15; (2):164-171.
Public notes

Contacts
Principal investigator
Name 27430 0
Dr EDWARD CHOW
Address 27430 0
Department of Radiation Oncology,
Odette Cancer Centre,
Sunnybrook Health Sciences Centre,
2075 Bayview Avenue,
Toronto, ON
M4N 3M5
Country 27430 0
Canada
Phone 27430 0
+1 416 480-4998
Fax 27430 0
Email 27430 0
[email protected]
Contact person for public queries
Name 10685 0
A/Prof Daniel Roos
Address 10685 0
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 10685 0
Australia
Phone 10685 0
+61 8 8222 4000
Fax 10685 0
+61 8 8222 2016
Email 10685 0
[email protected]
Contact person for scientific queries
Name 1613 0
A/Prof Daniel Roos
Address 1613 0
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 1613 0
Australia
Phone 1613 0
+61 8 8222 4000
Fax 1613 0
+61 8 8222 2016
Email 1613 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
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