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No longer recruiting (closed or complete)Last updated: 22 November 2024

LARK: This study is evaluating how accurate and effective radiation therapy for either primary or secondary liver cancer is when utilising a new type of real-time tumour localisation (called Kilovoltage Intrafraction Monitoring)Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18 - 85

Trial acronym

LARK

Clinical summary

Summary

Eligible participants will receive liver radiation therapy called Stereotactic Ablative Body Radiotherapy (SABR). Kilovoltage Intrafraction Monitoring (KIM) tracking will be tested during mock treatment. If it is found to be successful, it will be used throughout treatment. If it is found to be unsuccessful, cone beam CT imaging will be used instead.

Conditions

This trial is treating people with liver cancer

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • Your cancer has not spread to other parts of the body (localised).
  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are currently receiving treatment for your cancer.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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No longer recruiting (closed or complete) hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

University of Sydney

Scientific Title

Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)

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