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

June 5, 2017 updated by: AHS Cancer Control Alberta

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

SBRT for Oligo-metastatic Colorectal cancer

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Stereotactic Body Radiation Therapy
Radiation: Stereotactic Body Radiation Therapy
5 treatments given over 2 weeks
Other Names:
  • SBRT

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHS Cancer Control Alberta

Investigators

  • Principal Investigator: Richie Sinha, MD, Tom Baker Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2017

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

January 6, 2016

First Submitted That Met QC Criteria

May 31, 2017

First Posted (Actual)

June 5, 2017

Study Record Updates

Last Update Posted (Actual)

June 7, 2017

Last Update Submitted That Met QC Criteria

June 5, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC L-SBRT 15-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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