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

A

AHS Cancer Control Alberta

Status

Unknown

Conditions

Colonic Neoplasms
Neoplasm Metastasis

Treatments

Radiation: Stereotactic Body Radiation Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03175146
CRC L-SBRT 15-01

Details and patient eligibility

About

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

Full description

SBRT for Oligo-metastatic Colorectal cancer

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Experimental
Experimental group
Description:
Stereotactic Body Radiation Therapy
Treatment:
Radiation: Stereotactic Body Radiation Therapy

Trial contacts and locations

0

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Central trial contact

Richie Sinha, MD

Data sourced from clinicaltrials.gov

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