A Study to See Whether Stereotactic Body RadioTherapy (SBRT) Can Shrink Tumours Within the Liver Safely

Study Overview
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Brief Summary
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The proposed study will evaluate if curative intent SBRT can provide high response rates and clinically meaningful cancer control with acceptable toxicity specifically in patient with metastatic colorectal cancer (mCRC) who do not have surgical options and are no longer responding to systemic therapy

Detailed Description
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SBRT for Oligo-metastatic Colorectal cancer

Official Title
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Stereotactic Body RadioTherapy (SBRT) for Oligo-metastatic Colo-rectal Cancer With Bio-marker Evaluation for Early Progression

Conditions
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Colonic Neoplasms, Neoplasm Metastasis

Intervention / Treatment
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* Radiation: Stereotactic Body Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed Colo-rectal Cancer 1-3 Liver metastasis measurable on Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Surgically resected primary disease Technically/medically inoperable or patient declined surgery Progression or Stability after at least 1 Line of chemotherapy Adequate marrow function: Hb > 80g/L, Platelets > 100 x 109/L, White blood cell > 2 x 109/L Eastern Cooperative Oncology Group (ECOG) status 0-2 Age > 18 years Patient must sign study specific informed consent prior to study entry Exclusion Criteria: Prior liver radiation, or radiation in close proximity to planned treatment sites Prior invasive malignancy Severe, active co-morbidity Active hepatitis or Child Pugh Score B (9) or worse Pregnant or nursing women Extra hepatic disease: Any Bone/Any Brain, 2 or more Lung metastasis Life expectancy < 6 mo from any cause Concurrent chemotherapy Response to prior chemotherapy with minimal measurable disease in liver

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Stereotactic Body Radiation Therapy | Radiation: Stereotactic Body Radiation Therapy<br>* 5 treatments given over 2 weeks<br>* Other names: SBRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate within the treated liver lesion | RECIST Response | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Any progression of the disease | Up to 5 years | 
| Toxicity | Grade 3 CTCAE events | From date of randomization up to 5 years | 
| Quality of Life | Fact - H quality of life instrument | From date of Randomization to Death or Progression or 5 years whichever comes first. | 
| Median survival | Median survival | From date of randomization upto 5 years | 
| Overall survival | Survival | From date of randomization upto 5 years |