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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
14/05/2021

Titles & IDs
Public title
Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)
Scientific title
LARK: Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)
Secondary ID [1] 0 0
TROG1703 LARK
Universal Trial Number (UTN)
Trial acronym
TROG1703 LARK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Liver
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Difference in accumulated patient dose distribution with and without KIM - 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
Timepoint [1] 0 0
15-60 minutes (time of individual fraction delivery)
Secondary outcome [1] 0 0
Difference in treatment time with and without KIM - 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
Timepoint [1] 0 0
15-60 minutes (time of individual fraction delivery)
Secondary outcome [2] 0 0
Difference in imaging dose with and without KIM - 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
Timepoint [2] 0 0
15-60 minutes (time of individual fraction delivery)
Secondary outcome [3] 0 0
Difference in PTV margins with and without KIM - The clinical target volume (CTV) to planning target volume (PTV) margin with and without KIM will be recorded and analysed.
Timepoint [3] 0 0
15-60 minutes (time of individual fraction delivery)
Secondary outcome [4] 0 0
Difference in accumulated patient dose distribution with and without KIM based on the intra-treatment CBCT scans - 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.
Timepoint [4] 0 0
15-60 minutes (time of individual fraction delivery)
Secondary outcome [5] 0 0
Change in dose when using KIM with and without using MLC tracking - Difference between dose delivered using KIM with or without MLC tracking
Timepoint [5] 0 0
15-60 minutes (time of individual fraction delivery
Secondary outcome [6] 0 0
Proportion of local failures at two years for patients treated - Proportion of local failures at two years for patients treated as assessed using modified RECIST criteria
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
The proportion of grade 3 or higher toxicities - The proportion of grade 3 or higher toxicities, assessed using CTCAE v4.03
Timepoint [7] 0 0
2 years
Secondary outcome [8] 0 0
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) - 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.
Timepoint [8] 0 0
2 years
Secondary outcome [9] 0 0
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) - 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.
Timepoint [9] 0 0
18 months

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
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
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
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2049 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Primary and secondary liver cancer patients will receive liver SABR with or without KIM
intervention.
Trial website
https://clinicaltrials.gov/show/NCT02984566
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tim Wang, Dr
Address 0 0
Westmead Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Doan Nguyen, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 2 8627 1185
Fax 0 0
Email 0 0
d.nguyen@sydney.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/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 49 0
Dr
Name 49 0
Tim Wang
Address 49 0
Western Sydney Local Health District Cnr of Hawkesbury & Darcy Rd Westmead NSW 2145
Country 49 0
Australia
Phone 49 0
+61 2 9845 9636
Fax 49 0
Email 49 0
Tim.Wang1@health.nsw.gov.au
Contact person for public queries
Title 50 0
Ms
Name 50 0
Shona Silvester
Address 50 0
ACRF Image X Institute Room 214, Biomedical Building - C81 The University of Sydney NSW 2006
Country 50 0
Australia
Phone 50 0
+61 2 8627 1185
Fax 50 0
Email 50 0
shona.silvester@sydney.edu.au
Contact person for scientific queries
Title 51 0
Prof
Name 51 0
Paul Keall
Address 51 0
ACRF Image X Institute Suite 201, Biomedical Building - C81 The University of Sydney NSW 2006
Country 51 0
Australia
Phone 51 0
+61 2 8627 1159
Fax 51 0
Email 51 0
Paul.Keall@sydney.edu.au