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Liver CancerTROG1703 LARKNCT02984566

Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)

A study testing Kilovoltage Intrafraction Monitoring in people with Liver Cancer, run by University of Sydney at 4 sites in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Primary and secondary liver cancer patients will receive liver SABR with or without KIM intervention. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Liver Cancer
What is being tested?
Kilovoltage Intrafraction Monitoring
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
4 sitesAustralia
Study dates
14 Jan 2020to Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

Australia4 sites

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Nepean Hospital

    Penrith, New South Wales, 2750

  • Westmead Hospital

    Westmead, New South Wales, 2049

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

About this study

Official title: LARK: Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)

Primary and secondary liver cancer patients will receive liver SABR with or without KIM intervention.

Read the detailed description

This is a single arm, phase II, two stage study designed to evaluate cancer targeting accuracy, treatment outcomes and treatment efficiency in 46 patients eligible for SABR for either primary or secondary liver malignancy with the incorporation of KIM.

Conditions
Liver Cancer
Being tested
Kilovoltage Intrafraction Monitoring
Keywords
Primary liver cancer, Secondary liver cancer, Kilovoltage Intrafraction Monitoring, Stereotactic Ablative Body Radiation
Medical subject headings
Liver Neoplasms, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kilovoltage Intrafraction MonitoringDevice

    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.

Study groups in NCT02984566
Study groupRoleWhat they receive
SABR with or without KIMExperimentalAll 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.
Receives: Device: Kilovoltage Intrafraction Monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 15-60 minutes (time of individual fraction delivery)

Secondary outcomes (9)

  1. 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

    Measured: 15-60 minutes (time of individual fraction delivery)

  2. 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

    Measured: 15-60 minutes (time of individual fraction delivery)

  3. 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.

    Measured: 15-60 minutes (time of individual fraction delivery)

  4. 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.

    Measured: 15-60 minutes (time of individual fraction delivery)

  5. Change in dose when using KIM with and without using MLC tracking

    Difference between dose delivered using KIM with or without MLC tracking

    Measured: 15-60 minutes (time of individual fraction delivery

  6. 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

    Measured: 2 years

  7. The proportion of grade 3 or higher toxicities

    The proportion of grade 3 or higher toxicities, assessed using CTCAE v4.03

    Measured: 2 years

  8. 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.

    Measured: 2 years

  9. 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.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2016 (estimated)
  2. Study start14 Jan 2020
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02984566
Sponsor's protocol ID
TROG1703 LARK
Acronym
TROG1703 LARK
Status last verified
May 2026
First submitted
23 Nov 2016
Last updated
19 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymised data will be made available to researchers upon request, once evidence of ethical approval has been provided.

Publications

  • Lee YYD, Nguyen DT, Moodie T, O'Brien R, McMaster A, Hickey A, Pritchard N, Poulsen P, Tabaksblat EM, Weber B, Worm E, Pryor D, Chu J, Hardcastle N, Booth J, Gebski V, Wang T, Keall P. Study protocol of the LARK (TROG 17.03) clinical trial: a phase II trial investigating the dosimetric impact of Liver Ablative Radiotherapy using Kilovoltage intrafraction monitoring. BMC Cancer. 2021 May 3;21(1):494. doi: 10.1186/s12885-021-08184-x.

    PubMed 33941111

Questions about this trial

What is this clinical trial studying?

A study testing Kilovoltage Intrafraction Monitoring in people with Liver Cancer, run by University of Sydney at 4 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in accumulated patient dose distribution with and without KIM (time frame: 15-60 minutes (time of individual fraction delivery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02984566, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.

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