Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)

NCT02984566 | Active Not Recruiting

• 1 other identifier: TROG1703 LARK
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Liver Cancer

Keywords

Primary liver cancer; Secondary liver cancer; Kilovoltage Intrafraction Monitoring; Stereotactic Ablative Body Radiation

Outcome Measures

Primary Outcomes (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

  15-60 minutes (time of individual fraction delivery)

Secondary Outcomes (9)

• Difference in treatment time with and without KIM

  15-60 minutes (time of individual fraction delivery)

• Difference in imaging dose with and without KIM

  15-60 minutes (time of individual fraction delivery)

• Difference in PTV margins with and without KIM

  15-60 minutes (time of individual fraction delivery)

• Difference in accumulated patient dose distribution with and without KIM based on the intra-treatment CBCT scans

  15-60 minutes (time of individual fraction delivery)

• Change in dose when using KIM with and without using MLC tracking

  15-60 minutes (time of individual fraction delivery

Study Arms (1)

SABR with or without KIM

EXPERIMENTAL

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

Interventions

Kilovoltage Intrafraction Monitoring DEVICE

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.

SABR with or without KIM

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnant or lactating women

Sponsors & Collaborators

• University of Sydney: lead

Study Sites (4)

Nepean Hospital

Penrith, New South Wales, 2750, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2049, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Related Publications (1)

• 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.

  PMID: 33941111 DERIVED

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Tim Wang, Dr

  Westmead Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: December 7, 2016
• Study Start: January 14, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

AU (4)