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

Not Applicable

• Conditions: Neoplasm Metastasis; Colonic Neoplasms
• Interventions: Radiation: Stereotactic Body Radiation Therapy

• Registration Number: NCT03175146
• Lead Sponsor: AHS Cancer Control Alberta

Brief Summary

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

SBRT for Oligo-metastatic Colorectal cancer

Study Timeline

• Study First Submitted: 2016-01-06
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-31
• Study First Posted: 2017-06-05
• Last Update Submitted: 2017-06-05
• Last Update Posted: 2017-06-07
• Study Start: 2017-09
• Primary Completion: 2021-01
• Study Completion: 2021-01

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Stereotactic Body Radiation Therapy	Stereotactic Body Radiation Therapy

Primary Outcome Measures

Name	Time	Method
Response rate within the treated liver lesion	6 months	RECIST Response

Secondary Outcome Measures

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