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Trial registered on ANZCTR


Registration number
ACTRN12622001200774
Ethics application status
Approved
Date submitted
31/08/2022
Date registered
7/09/2022
Date last updated
28/04/2024
Date data sharing statement initially provided
7/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The CONSOLE Trial - A Randomised trial for the treatment of painful bony metastases not located in the spine using Conventional or Stereotactic Radiotherapy
Scientific title
Conventional or Stereotactic Radiotherapy for the palliation of non-spine bone metastases: A randomised phase III trial.
Secondary ID [1] 307801 0
None
Universal Trial Number (UTN)
U1111-1281-7509
Trial acronym
CONSOLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Cancer 327384 0
Condition category
Condition code
Cancer 324506 324506 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ARM B: Stereotactic Body Radiation Therapy (SBRT): 24Gy in 2 fractions delivered with a minimum of 1 and a maximum of 3 days gap days between fractions per treated site. If multiple sites are treated, these can be treated on the same day or alternate days and all sites must be treated within 14 calendar days.
Patients are required to attend a treatment planning session within 14 days of the start of treatment. The planning procedure will involve a computed-tomography (CT) scan as well as completion of a Magnetic Resonance Imaging (MRI) scan (if one hasn't been done within 6 weeks of starting treatment) and if the study doctor decides it is necessary, also a Positron Emission Tomography (PET) scan.
Treatment is expected to take around 45 minutes per treatment. The intervention will be prescribed by a radiation oncologist and administered by radiation therapists.
During treatment, imaging will be completed to ensure treatment is administered accurately.
All patients will complete quality of life and a pain and medication diary.
Intervention code [1] 324261 0
Treatment: Other
Comparator / control treatment
The comparator/control treatment for this study is the conventional radiotherapy (Arm A). The aim is to determine if interventional arm is superior to the comparator/control treatment.
ARM A: Conventional Radiotherapy: 20Gy in 5 fractions or 8Gy in 1 fraction determined at the discretion of the treating radiation oncologist. A maximum of 1 fraction per day and all fractions to be delivered within 7 calendar days for a given site (or 8-10 days permitted only over public holiday periods). If multiple sites are treated, all sites must be treated within a 14-day calendar period.
Patients are required to attend a treatment planning session within 14 days of the start of treatment. The planning procedure will involve a computed-tomography (CT) scan
Treatment is expected to take around 15 minutes per treatment. The treatment will be prescribed by a radiation oncologist and administered by radiation therapists.
During treatment, imaging will be completed to ensure treatment is administered accurately.
All patients will complete quality of life and a pain and medication diary.
Control group
Active

Outcomes
Primary outcome [1] 332339 0
Complete pain response from SBRT compared to conventional radiotherapy measured by a combination of pain and medication assessment as assessed through completion of a pain and medication diary completed by the patient. Complete response defined to be a pain score of 0 at the treated sites and no associated increase in daily oral morphine equivalent consumption (quantified by oral morphine equivalent daily dose (OMEDD)).
Timepoint [1] 332339 0
Assessed 3 months following last day of radiotherapy.
Secondary outcome [1] 413080 0
Complete pain response per lesion from SBRT compared to conventional radiotherapy measured by a combination of pain and medication assessment as assessed through completion of a pain and medication diary completed by the patient.. Complete response defined to be a pain score of 0 at the treated sites and no associated increase in analgesic consumption.
Timepoint [1] 413080 0
Assessed 3 months following last day of radiotherapy.
Secondary outcome [2] 413081 0
Complete pain response per patient and per lesion from SBRT compared to conventional radiotherapy measured by a combination of pain and medication assessment as assessed through completion of a pain and medication diary completed by the patient. Complete response defined to be a pain score of 0 at the treated sites and no associated increase in analgesic consumption.
Timepoint [2] 413081 0
Assessed 6 months following last day of radiotherapy.
Secondary outcome [3] 413082 0
Partial pain response per patient and per lesion post treatment defined by a combination of a reduction in pain score of 2 on a scale from 0 to 10 (International Bone Metastases Consensus Working Party(IBMCWP) criteria) with no increase in analgesics (assessed using OMEDD) or a 25% decrease in analgesic consumption without an increase in pain. This is assessed through completion of a pain and medication diary completed by the patient.
Timepoint [3] 413082 0
Assessed 3 and 6 months following last day of radiotherapy.
Secondary outcome [4] 413083 0
General quality of life measured by the EQ5D-5L instrument.
Timepoint [4] 413083 0
Assessed at baseline, and then 2 weeks, and 3 and 6 months following last day of radiotherapy.
Secondary outcome [5] 413084 0
Rate of acute adverse events as defined by the NCI CTCAE v5
Timepoint [5] 413084 0
Assessed at baseline, last day of radiotherapy, and then 2 weeks, and 3 months following last day of radiotherapy.
Secondary outcome [6] 413085 0
Cost-utility analysis of treatment-related costs and patient-reported QoL measured in quality-adjusted life years (QALYs). This will be sourced from review of patient charges and review of clinic resources.
Timepoint [6] 413085 0
Assessed 6 months following last day of radiotherapy.
Secondary outcome [7] 413086 0
Rates of protocol deviations, as defined by the trial-specific Radiation Therapy Quality Assurance (RTQA) protocol. This will be sourced from central review of quality assurance review of radiation therapy treatment plans.
Timepoint [7] 413086 0
Assessed at end of radiotherapy treatment
Secondary outcome [8] 413697 0
Disease specific quality of life measured by the European Organisation for. Research and Treatment of Cancer (EORTC) QLQ C30 and Bone Metastases Module (BM22) instruments.
Timepoint [8] 413697 0
Assessed at baseline, and then 2 weeks, and 3 and 6 months following last day of radiotherapy.
Secondary outcome [9] 413698 0
Rate of late adverse events as defined by the NCI CTCAE v5
Timepoint [9] 413698 0
Assessed at 6 months following last day of radiotherapy.

Eligibility
Key inclusion criteria
Age 18 years or older
World Health Organisation Performance Status (WHO PS) 0-2
Histological confirmation of primary malignancy (exclude seminoma, Small Cell lung Cancer (SCLC) and haematological malignancies)
Able to consent to trial
Able to safely deliver SBRT and conventional radiotherapy to all sites of disease
Life expectancy >6 months
Able to complete QoL and pain questionnaires
1-3 Lesions <5cm in maximum dimension suitable for SBRT (excluding skull and mandible) with baseline pain score of at least 2 in target area. Lesions can be in close proximity and included in the one plan/treatment area if required.
Patients with spinal or intracranial metastases are eligible for inclusion but these sites will not be treated or assessed for the purpose of this trial
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are candidates for curative intent or disease-modifying treatment for oligometastatic disease
Patients unable or unwilling to comply with protocol requirements.
Pregnancy or trying to become pregnant
High fracture risk requiring fixation, Mirel’s score greater than or equal to 9
Chemotherapy or Immunotherapy within one week of radiotherapy
Previous radiotherapy at the treatment site(s).

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)
Randomisation will be performed centrally by the sponsor via computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed with 1:1 allocation using random block sizes of 2 and 4 by an independent researcher, and stratified for radioresistant histologies (binary variable, where radioresistant histology will be coded ‘Yes’ if the patient has melanoma, renal cell carcinoma, colorectal or sarcoma, and ‘No’, if the patient has any other histological type) and site/centre. Where possible, project staff conducting the assessments will be blinded to participants’ allocation. The block sizes will not be disclosed, to ensure concealment.
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
Conventional summary statistics will be presented to describe the characteristics of each trial arm. For all normally distributed variables, means and standard deviations will be used for reporting purposes. Medians and interquartile range will be used to summarise continuous non-normal variables, which had been determined to be non-normal using the Shapiro-Wilk test. Counts and percentages will be used to summarise categorical variables.
For the analysis of the primary endpoint, which is dichotomous, the difference in proportion of complete pain response between the two arms at 3 months post-initiation of treatment will be analysed using a logistic regression model, with treatment group included as the main effect. The effect estimate will be reported as an odds ratio with 95% confidence interval (CI). Analysis of the primary endpoint will be based on the intention to treat population. A p value < 0.05 will be considered statistically significant.
To investigate factors associated with the variability in response, univariable and multivariable binomial logistic regression will be used, with pre-specified variables that will be examined to include histological subtype, number of painful bony lesions, and baseline performance status.
For the secondary endpoints with binary outcomes, such as per lesion complete pain response at 3 months, complete pain response at 6 months (per patient) and partial pain response at 3 and 6 months (per lesion and per patient), a binary logistic regression model will be used to examine the difference between treatment groups. For secondary endpoints with continuous outcomes, such as quality of life scores, a linear regression model will be used. Effect estimates will be presented as mean difference (95%CI). For secondary endpoints with count outcomes, a Poisson regression model will be used. Effect estimates will be presented as incidence rate ratio (95% CI). For secondary endpoints with time-to-event outcomes, such as overall survival, a Cox proportional hazards model will be used. Effect estimates will be presented as hazard ratio (95% CI). For each model the treatment group will be included as a main effect, and the baseline value of the outcome variable will be included where appropriate.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/02/2023
Actual
Date of last participant enrolment
Anticipated
3/02/2027
Actual
Date of last data collection
Anticipated
1/08/2027
Actual
Sample size
Target
146
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS
Recruitment hospital [1] 22993 0
Icon Cancer Centre Hobart - Hobart
Recruitment hospital [2] 23005 0
Icon Cancer Centre Wahroonga - Wahroonga
Recruitment hospital [3] 23006 0
Icon Cancer Centre Gold Coast Private Hospital - Southport
Recruitment hospital [4] 23007 0
Icon Cancer Centre Gold Coast University Hospital - Southport
Recruitment hospital [5] 26100 0
Icon Cancer Centre Richmond - Richmond
Recruitment hospital [6] 26101 0
Icon Cancer Centre Mulgrave - Mulgrave
Recruitment hospital [7] 26102 0
Icon Cancer Centre Epworth Freemasons - East Melbourne
Recruitment postcode(s) [1] 38305 0
7000 - Hobart
Recruitment postcode(s) [2] 38321 0
2076 - Wahroonga
Recruitment postcode(s) [3] 38322 0
4215 - Southport
Recruitment postcode(s) [4] 41956 0
3121 - Richmond
Recruitment postcode(s) [5] 41957 0
3170 - Mulgrave
Recruitment postcode(s) [6] 41958 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 312071 0
Charities/Societies/Foundations
Name [1] 312071 0
Icon Cancer Foundation
Country [1] 312071 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Icon Cancer Foundation
Address
Level 1/22 Cordelia St, South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 313578 0
None
Name [1] 313578 0
Address [1] 313578 0
Country [1] 313578 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311479 0
St Vincent's Hospital Melbourne Human Research Ethics Committee (HREC)
Ethics committee address [1] 311479 0
41 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 311479 0
Australia
Date submitted for ethics approval [1] 311479 0
14/09/2022
Approval date [1] 311479 0
13/12/2022
Ethics approval number [1] 311479 0

Summary
Brief summary
The CONSOLE clinical trial aims to compare two schedules of radiotherapy in the treatment of painful cancer that has spread to bones not located in the spine.

Who is it for?
You may be eligible for this study if you are an adult over the age of 18 who has been diagnosed with cancer that has spread to your bones not located in the spine and is causing you pain.

Study details
Participants will be randomly assigned to one of two radiotherapy schedules as part of this study.
In Arm A, called the conventional treatment or current standard of care, participants will be either given in one (1) treatment on a single day or five (5) treatments over a period of a maximum of seven (7) calendar days for each area which is painful. If you are having more than one area treated, all areas must be completed within 14 calendar days. Each treatment will go for around 15 to 30 minutes.
.
In Arm B, called Sterotactic Body Radiotherapy (SBRT), participants will be given in two (2) treatments with a minimum of one (1) and a maximum of three (3) days gap between treatments for each area which is painful. If you are having more than one area treated, all areas must be completed within 14 calendar days. radiotherapy which is given in two treatments. Each treatment will take around 30 to 45 minutes.

Questionnaires and pain and medication diary will completed at the initial assessment, last day of treatment, 2 weeks after radiotherapy and at 3 and 6 months following the last treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121242 0
Dr Angela Yates
Address 121242 0
Icon Cancer Centre Wahroonga, Sydney Adventist Hospital Level 2, Clark Tower/185 Fox Valley Rd, Wahroonga NSW 2076
Country 121242 0
Australia
Phone 121242 0
+61 2 9480 4200
Fax 121242 0
Email 121242 0
[email protected]
Contact person for public queries
Name 121243 0
Lloyd Smyth
Address 121243 0
Icon Cancer Centre, Level 1/22 Cordelia St, South Brisbane QLD 4101
Country 121243 0
Australia
Phone 121243 0
+61 7 3737 4500
Fax 121243 0
Email 121243 0
[email protected]
Contact person for scientific queries
Name 121244 0
Angela Yates
Address 121244 0
Icon Cancer Centre Wahroonga, Sydney Adventist Hospital Level 2, Clark Tower/185 Fox Valley Rd, Wahroonga NSW 2076
Country 121244 0
Australia
Phone 121244 0
+61 2 9480 4200
Fax 121244 0
Email 121244 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Unknown at this stage


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.