Clinical trial · Interventional
Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)
LARK: Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)
NCT02984566CI-TRIAL-00112077TROG1703 LARKactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary and secondary liver cancer patients will receive liver SABR with or without KIM intervention.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Kilovoltage Intrafraction Monitoring | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SABR with or without KIM
- description
- 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.
- interventionNames
- Device: Kilovoltage Intrafraction Monitoring
Primary outcomes (1)
- measure
- Difference in accumulated patient dose distribution with and without KIM
- timeFrame
- 15-60 minutes (time of individual fraction delivery)
- description
- 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
Secondary outcomes (9)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLee 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