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Trial registered on ANZCTR


Registration number
ACTRN12613001066774
Ethics application status
Not yet submitted
Date submitted
23/09/2013
Date registered
24/09/2013
Date last updated
16/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Liver Image Guided High Dose Radiation Therapy for the Treatment of Colorectal Liver Metastases
Scientific title
TROG13.02: A phase II single arm trial of stereotactic image guided radiotherapy for colo-rectal liver metastases to determine if it can be performed in a multidisciplinary setting with acceptable toxicity (Liver Image Guided High Dose Radiation Therapy)
Secondary ID [1] 283134 0
None
Universal Trial Number (UTN)
U1111-1136-9625
Trial acronym
LIGHT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver metastases from colo-rectal cancer 289985 0
Condition category
Condition code
Cancer 290367 290367 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stereotactic Radiation;
Six fractions of radiotherapy delivered with 2-3 fractions per week at least one fraction 24 hours apart per week with risk adjusted dosing based on mean liver dose;
1. 60Gy in 6# delivered over 2-3 weeks for mean liver dose < 13.3Gy
2. 51Gy in 6# delivered over 2-3 weeks for mean liver dose 13.3-15.0Gy
3. 42Gy in 6# delivered over 2-3 weeks for mean liver dose 15.1-17.5Gy
Intervention code [1] 287857 0
Treatment: Devices
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290579 0
To determine that delivery of high dose stereotactic image guided radiotherapy for colo-rectal liver metastases can be performed in a multidisciplinary setting. Successful delivery of stereotactic image guided radiotherapy for liver cancer will be indicated by 0 major clinical violations and <4 minor clinical violations on the planning review.
Timepoint [1] 290579 0
3 months post treatment
Secondary outcome [1] 304831 0
Determine the efficacy and toxicity of stereotactic image guided radiotherapy in patients with liver metastases, determined by CT scans and toxicity measurements (Child-Pugh function and CTCAE)
Timepoint [1] 304831 0
3 years post treatment
Secondary outcome [2] 304832 0
Determine the dose response relationship of stereotactic image guided radiotherapy with decline in liver function as measured by HIDA liver function scans and biochemistry
Timepoint [2] 304832 0
3 years post treatment
Secondary outcome [3] 304833 0
Determine the prognostic value of pre treatment and post treatment 18-FDG PET scans in treating liver metastases with stereotactic image guided radiotherapy
Timepoint [3] 304833 0
Pre Treatment and 3 months post treatment
Secondary outcome [4] 304834 0
Develop standardised normal tissue dose reporting, dose prescription and planning for treatment of liver SBRT using image guidance
Timepoint [4] 304834 0
Pre Treatment
Secondary outcome [5] 304835 0
Compare the variance in risks between different TCP/NTCP models with SBRT plans and to observed rates of toxicity
Timepoint [5] 304835 0
Pre-treatment and 3 yrs post treatment
Secondary outcome [6] 304836 0
Assess potential prognostic and predictive factors for liver SBRT
Timepoint [6] 304836 0
3 years post treatment

Eligibility
Key inclusion criteria
Patients with up to 5 medically or surgically inoperable colo-rectal cancer liver metastases with a maximum metastasis size of 8cm in whom progression of the liver disease is expected to cause significant morbidity are eligible for the trial
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with previous upper abdominal radiotherapy or inadequate liver reserve (<800mL of normal liver) will be excluded from the trial.

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
Statistical methods / analysis
Considering that the percentage of participants having no major violation and less than 4 minor violations will be 90% and considering an unacceptable percentage as 70% or less, the required sample size for 80% power is 28 participants. Allowing for potential drop out of 2 participants a total sample size of 30 participants will be recruited.
Major and minor violations for each treatment course will be described and the 95% CI will be reported for the unacceptable rate of 1 major and/or 4 minor treatment violations.
Means and their 95% confidence intervals for each outcome will be used to assess variability of TCP/NTCP between each dose strata. Multilevel models will be used to account for and investigate centre level differences in the outcomes. Interclass correlation as well as mixed modelling will be used to assess potential variation.
Different NTCP/TCP models will be used to determine estimated TCP/NTCP for each patient and the variance detected between the models using linear regression. The model parameters will be adjusted to provide line of best fit for each strata comparing decline in liver function (HIDA) and observed tumour control.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
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)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 288025 0
Self funded/Unfunded
Name [1] 288025 0
Address [1] 288025 0
Country [1] 288025 0
Primary sponsor type
Other Collaborative groups
Name
Trans Tasman Radiation Oncology Group (TROG)
Address
Calvary Mater Newcastle, Locked Bag 7, HRMC, NSW 2310,
Country
Australia
Secondary sponsor category [1] 286743 0
None
Name [1] 286743 0
Address [1] 286743 0
Country [1] 286743 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289948 0
SWSLHD Human Research Ethics Committee
Ethics committee address [1] 289948 0
Research and Ethics Office
Locked Bag 7279
LIVERPOOL BC NSW 1871
Ethics committee country [1] 289948 0
Australia
Date submitted for ethics approval [1] 289948 0
01/06/2017
Approval date [1] 289948 0
Ethics approval number [1] 289948 0

Summary
Brief summary
Colo-rectal cancer is increasing in the community and the most common site of spread is to the liver. Isolated liver deposits can be cured by surgery. For patients not fit or suitable for surgery other options need to be investigated.
This clinical trial is investigating the use of stereotactic image guided radiotherapy for the treatment of colorectal liver metastases.

Who is it for? This study will recruit participants that are aged 18 years or above and have up to 5 medically or surgically inoperable colorectal cancer liver metastases.

Study details: All participants in this study will undergo stereotactic radiation therapy. This is a type of external radiation therapy that uses special equipment to more precisely deliver radiation to a tumour. Six radiotherapy sessions will be delivered over 2-3 weeks. Participants will be assessed for 3 years post treatment in order to evaluate treatment safety and disease response.
Trial website
www.trog.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42614 0
Dr Mark Lee
Address 42614 0
Liverpool Hospital,
Elizabeth Street
Liverpool
NSW, 2170
Country 42614 0
Australia
Phone 42614 0
+61 2 9828 3000
Fax 42614 0
Email 42614 0
Mark.Lee@sswahs.nsw.gov.au
Contact person for public queries
Name 42615 0
Ms Rebecca Montomery
Address 42615 0
TROG Central Office
Calvary Mater Newcastle
Locked Bag 7
HRMC
NSW 2310
Country 42615 0
Australia
Phone 42615 0
+61 2 40143910
Fax 42615 0
Email 42615 0
Rebecca.montgomery@trog.com.au
Contact person for scientific queries
Name 42616 0
Dr Mark Lee
Address 42616 0
Liverpool Hospital
Elizabeth Street
Liverpool
NSW, 2170
Country 42616 0
Australia
Phone 42616 0
+61 2 9828 3000
Fax 42616 0
Email 42616 0
Mark.Lee@sswahs.nsw.gov.au

No data has been provided for results reporting
Summary results
Not applicable