iver Image Guided High Dose Radiation Therapy for the Treatment of Colorectal Liver Metastases

Phase 2

Withdrawn

• Conditions: iver metastases from colo-rectal cancer; Liver metastases from colo-rectal cancer; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12613001066774
• Lead Sponsor: Trans Tasman Radiation Oncology Group (TROG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients with up to 5 medically or surgically inoperable colo-rectal cancer liver metastases with a maximum metastasis size of 8cm in whom progression of the liver disease is expected to cause significant morbidity are eligible for the trial

Exclusion Criteria

Patients with previous upper abdominal radiotherapy or inadequate liver reserve (<800mL of normal liver) will be excluded from the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine that delivery of high dose stereotactic image guided radiotherapy for colo-rectal liver metastases can be performed in a multidisciplinary setting. Successful delivery of stereotactic image guided radiotherapy for liver cancer will be indicated by 0 major clinical violations and <4 minor clinical violations on the planning review. [3 months post treatment ]

Secondary Outcome Measures

Name	Time	Method
Determine the efficacy and toxicity of stereotactic image guided radiotherapy in patients with liver metastases, determined by CT scans and toxicity measurements (Child-Pugh function and CTCAE)<br>[3 years post treatment];Determine the dose response relationship of stereotactic image guided radiotherapy with decline in liver function as measured by HIDA liver function scans and biochemistry[3 years post treatment ];Determine the prognostic value of pre treatment and post treatment 18-FDG PET scans in treating liver metastases with stereotactic image guided radiotherapy[Pre Treatment and 3 months post treatment];Develop standardised normal tissue dose reporting, dose prescription and planning for treatment of liver SBRT using image guidance [Pre Treatment];Compare the variance in risks between different TCP/NTCP models with SBRT plans and to observed rates of toxicity[Pre-treatment and 3 yrs post treatment];Assess potential prognostic and predictive factors for liver SBRT[3 years post treatment]