Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM) (TROG1703 LARK)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02984566 |
Recruitment Status :
Recruiting
First Posted : December 7, 2016
Last Update Posted : January 25, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Liver Cancer | Device: Kilovoltage Intrafraction Monitoring | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 46 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | LARK: Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM) |
Actual Study Start Date : | January 14, 2020 |
Estimated Primary Completion Date : | July 2023 |
Estimated Study Completion Date : | December 2024 |

Arm | Intervention/treatment |
---|---|
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.
|
Device: 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. |
- Difference in accumulated patient dose distribution with and without KIM [ Time Frame: 15-60 minutes (time of individual fraction delivery) ]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
- Difference in treatment time with and without KIM [ Time Frame: 15-60 minutes (time of individual fraction delivery) ]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
- Difference in imaging dose with and without KIM [ Time Frame: 15-60 minutes (time of individual fraction delivery) ]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
- Difference in PTV margins with and without KIM [ Time Frame: 15-60 minutes (time of individual fraction delivery) ]The clinical target volume (CTV) to planning target volume (PTV) margin with and without KIM will be recorded and analysed.
- Difference in accumulated patient dose distribution with and without KIM based on the intra-treatment CBCT scans [ Time Frame: 15-60 minutes (time of individual fraction delivery) ]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.
- Change in dose when using KIM with and without using MLC tracking [ Time Frame: 15-60 minutes (time of individual fraction delivery ]Difference between dose delivered using KIM with or without MLC tracking
- Proportion of local failures at two years for patients treated [ Time Frame: 2 years ]Proportion of local failures at two years for patients treated as assessed using modified RECIST criteria
- The proportion of grade 3 or higher toxicities [ Time Frame: 2 years ]The proportion of grade 3 or higher toxicities, assessed using CTCAE v4.03
- 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) [ Time Frame: 2 years ]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.
- 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) [ Time Frame: 18 months ]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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984566
Contact: Doan Nguyen, PhD | +61 2 8627 1185 | d.nguyen@sydney.edu.au | |
Contact: Natalie Plant, Masters | +61 2 8627 1133 | natalie.plant@sydney.edu.au |
Australia, New South Wales | |
Nepean Hospital | Recruiting |
Penrith, New South Wales, Australia, 2750 | |
Contact: Kirsten van Gysen | |
Principal Investigator: Kirsten van Gysen | |
Westmead Hospital | Recruiting |
Westmead, New South Wales, Australia, 2049 | |
Contact: Tracy Pearl-Larsson 02 8890 5200 Tracy.Pearl-Larson@health.nsw.gov.au | |
Principal Investigator: Tim Wang | |
Australia, Queensland | |
Princess Alexandra Hospital | Recruiting |
Woolloongabba, Queensland, Australia, 4102 | |
Contact: Yoo Young Lee | |
Principal Investigator: Yoo Young Lee | |
Australia, Victoria | |
Peter MacCallum Cancer Centre | Recruiting |
Melbourne, Victoria, Australia, 3000 | |
Contact: Julie Chu | |
Principal Investigator: Julie Chu |
Principal Investigator: | Tim Wang, Dr | Westmead Hospital |
Responsible Party: | University of Sydney |
ClinicalTrials.gov Identifier: | NCT02984566 |
Other Study ID Numbers: |
TROG1703 LARK |
First Posted: | December 7, 2016 Key Record Dates |
Last Update Posted: | January 25, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Anonymised data will be made available to researchers upon request, once evidence of ethical approval has been provided. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Primary liver cancer Secondary liver cancer Kilovoltage Intrafraction Monitoring Stereotactic Ablative Body Radiation |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Liver Diseases |