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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02984566
Additional trial details provided through ANZCTR are available at the end of this record.
Registration number
NCT02984566
Ethics application status
Date submitted
23/11/2016
Date registered
7/12/2016
Date last updated
13/02/2024
Titles & IDs
Public title
Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)
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Scientific title
LARK: Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)
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Secondary ID [1]
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TROG1703 LARK
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Universal Trial Number (UTN)
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Trial acronym
TROG1703 LARK
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Liver Cancer
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Condition category
Condition code
Cancer
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Liver
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Kilovoltage Intrafraction Monitoring
Experimental: SABR with or without KIM - All patients will receive liver SABR. Kilovoltage Intrafraction Monitoring (KIM) tracking will be trialed during mock treatment. If KIM is successful, it will be used throughout treatment. If unsuccessful, cone beam CT will be used instead.
Treatment: Devices: Kilovoltage Intrafraction Monitoring
KIM is a novel intrafraction real-time tumour localization method. It involves a single gantry-mounted kV x-ray imager acquiring 2D projections of implanted fiducial markers. 3D positions are then reconstructed by maximum likelihood estimation of a 3D probability density function.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Difference in accumulated patient dose distribution with and without KIM
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Assessment method [1]
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Isodose distributions and dose volume histograms for each session will be calculated with KIM corrections as treated, and estimated without KIM corrections. The planning CT scan will be used for this assessment
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Timepoint [1]
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15-60 minutes (time of individual fraction delivery)
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Secondary outcome [1]
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Difference in treatment time with and without KIM
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Assessment method [1]
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The time taken for the KIM treatments compared with the time taken for similar treatments from previous patients, accounting for the difference in the time and number of patient images acquired and the time taken to adjust the patient's position during treatment
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Timepoint [1]
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15-60 minutes (time of individual fraction delivery)
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Secondary outcome [2]
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Difference in imaging dose with and without KIM
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Assessment method [2]
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The KIM procedure adds radiation dose with the kilovoltage images. However, there may be fewer volumetric cone beam computed tomography (CBCT) scans acquired. This difference in dose will be estimated and analysed
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Timepoint [2]
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15-60 minutes (time of individual fraction delivery)
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Secondary outcome [3]
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Difference in PTV margins with and without KIM
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Assessment method [3]
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The clinical target volume (CTV) to planning target volume (PTV) margin with and without KIM will be recorded and analysed.
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Timepoint [3]
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15-60 minutes (time of individual fraction delivery)
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Secondary outcome [4]
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Difference in accumulated patient dose distribution with and without KIM based on the intra-treatment CBCT scans
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Assessment method [4]
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Isodose distributions and dose volume histograms for each session will be calculated with KIM corrections as treated, and estimated without KIM corrections. The intratreatment CBCT scans will be used for this assessment.
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Timepoint [4]
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15-60 minutes (time of individual fraction delivery)
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Secondary outcome [5]
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Change in dose when using KIM with and without using MLC tracking
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Assessment method [5]
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Difference between dose delivered using KIM with or without MLC tracking
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Timepoint [5]
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15-60 minutes (time of individual fraction delivery
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Secondary outcome [6]
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Proportion of local failures at two years for patients treated
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Assessment method [6]
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Proportion of local failures at two years for patients treated as assessed using modified RECIST criteria
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Timepoint [6]
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2 years
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Secondary outcome [7]
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The proportion of grade 3 or higher toxicities
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Assessment method [7]
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The proportion of grade 3 or higher toxicities, assessed using CTCAE v4.03
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Timepoint [7]
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2 years
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Secondary outcome [8]
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Patient-reported quality of life as measured by the European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 (EORTC QLQ-C30)
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Assessment method [8]
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To compare change in Quality of Life, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30 (Version 3)) from baseline at completion of radiation therapy and at 6 weeks, 3, 6, 12, 18 and 24 months post-radiation therapy. The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). The questionnaire will be self-administered and will be given in patient's mother tongue.
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Timepoint [8]
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2 years
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Secondary outcome [9]
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Patient-reported quality of life as measured by the European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Hepatocellular Carcinoma 18 Module (EORTC QLQ-HCC18)
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Assessment method [9]
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To compare change in Quality of Life related to hepatocellular carcinoma (HCC) as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Hepatocellular Carcinoma 18 Module (EORTC QLQ-HCC) from baseline at completion of radiation therapy and at 6 weeks, 3, 6, 12 and 18 months post-radiation therapy. The questionnaire will be self-administered and will be given to patients proficient in English. EORTC-QLQ-HCC18: includes HCC-specific symptoms or problems. Questions used 4-point Likert scale from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.
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Timepoint [9]
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18 months
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Eligibility
Key inclusion criteria
- ECOG performance status 0-1
- Life expectancy >6 months
- Number of lesions: = 3
- Lesion size : < 10 cm for a single lesion (and up to 10 cm cumulative diameter for
multiple lesions)
- Child-Pugh A or B7 within 6 weeks prior to study entry
- Unsuitable for RFA or resection or transplant
- Distance from GTV to luminal structures (i.e., oesophagus, stomach, duodenum, small or
large bowel) = 10mm
- All blood work obtained within 6 weeks prior to study entry with adequate organ
function
- May have had previous surgery, RFA or ethanol injection
- Patient must have been discussed at multidisciplinary tumour board with consensus
opinion for SBRT
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Minimum age
18
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- HCC/cholangiocarcinoma with evidence of metastatic disease including nodal or distant
metastases
- Metastatic disease with complete liver disease response to first-line chemotherapy
(i.e. no target for SBRT)
- Previous radiation to the liver (including SIRTEX)
- Untreated HIV or active hepatitis B/C
- On systemic antineoplastic drug therapy within 7 days before inclusion
- Pregnant or lactating women
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/01/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
32
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Nepean Hospital - Penrith
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Recruitment hospital [2]
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Westmead Hospital - Westmead
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Recruitment hospital [3]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [4]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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2750 - Penrith
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Recruitment postcode(s) [2]
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2049 - Westmead
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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3000 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Sydney
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Primary and secondary liver cancer patients will receive liver SABR with or without KIM
intervention.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02984566
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Tim Wang, Dr
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Address
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Westmead Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02984566
Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
NSW
Funding & Sponsors
Primary sponsor
University
Primary sponsor name
University of Sydney
Primary sponsor address
Commercial Developments & Industry Partnerships,
F23 Administration Building,
Corner of Eastbourne and City Road,
The University of Sydney, NSW 2006 Australia
Primary sponsor country
Australia
Ethics approval
Ethics application status
Approved
Public notes
Contacts
Principal investigator
Title
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Dr
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Name
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Tim Wang
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Address
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Western Sydney Local Health District Cnr of Hawkesbury & Darcy Rd Westmead NSW 2145
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Country
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Australia
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Phone
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+61 2 9845 9636
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Fax
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Email
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[email protected]
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Contact person for public queries
Title
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Ms
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Name
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Shona Silvester
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Address
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ACRF Image X Institute Room 214, Biomedical Building - C81 The University of Sydney NSW 2006
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Country
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Australia
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Phone
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+61 2 8627 1185
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Title
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Prof
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Name
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Paul Keall
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Address
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ACRF Image X Institute Suite 201, Biomedical Building - C81 The University of Sydney NSW 2006
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Country
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Australia
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Phone
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+61 2 8627 1159
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Fax
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Email
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[email protected]
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