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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03175146

Enrollment

Registered

2017-06-05

Start date

2017-09-30

Completion date

2021-01-31

Last updated

2017-06-07

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

Conditions

Colonic Neoplasms, Neoplasm Metastasis

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

Interventions

RADIATIONStereotactic Body Radiation Therapy

5 treatments given over 2 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Response rate within the treated liver lesion	6 months	RECIST Response

Secondary

Measure	Time frame	Description
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
Overall survival	From date of randomization upto 5 years	Survival

Contacts

Primary ContactRichie Sinha, MD

richie.sinha@ahs.ca403-476-2601

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026