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

TROG13.02: A phase II single arm trial of stereotactic image guided radiotherapy for colo-rectal liver metastases to determine if it can be performed in a multidisciplinary setting with acceptable toxicity (Liver Image Guided High Dose Radiation Therapy)

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001066774

Acronym

LIGHT

Enrollment

Registered

2013-09-24

Start date

2017-07-01

Completion date

2019-01-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Colo-rectal cancer is increasing in the community and the most common site of spread is to the liver. Isolated liver deposits can be cured by surgery. For patients not fit or suitable for surgery other options need to be investigated. This clinical trial is investigating the use of stereotactic image guided radiotherapy for the treatment of colorectal liver metastases. Who is it for? This study will recruit participants that are aged 18 years or above and have up to 5 medically or surgically inoperable colorectal cancer liver metastases. Study details: All participants in this study will undergo stereotactic radiation therapy. This is a type of external radiation therapy that uses special equipment to more precisely deliver radiation to a tumour. Six radiotherapy sessions will be delivered over 2-3 weeks. Participants will be assessed for 3 years post treatment in order to evaluate treatment safety and disease response.

Interventions

Stereotactic Radiation; Six fractions of radiotherapy delivered with 2-3 fractions per week at least one fraction 24 hours apart per week with risk adjusted dosing based on mean liver dose; 1. 60Gy in 6# delivered over 2-3 weeks for mean liver dose < 13.3Gy 2. 51Gy in 6# delivered over 2-3 weeks for mean liver dose 13.3-15.0Gy 3. 42Gy in 6# delivered over 2-3 weeks for mean liver dose 15.1-17.5Gy

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results