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

Primary Purpose

Colonic Neoplasms, Neoplasm Metastasis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stereotactic Body Radiation Therapy
Sponsored by
AHS Cancer Control Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Neoplasms

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Experimental

    Arm Description

    Stereotactic Body Radiation Therapy

    Outcomes

    Primary Outcome Measures

    Response rate within the treated liver lesion
    RECIST Response

    Secondary Outcome Measures

    Progression-free survival
    Any progression of the disease
    Toxicity
    Grade 3 CTCAE events
    Quality of Life
    Fact - H quality of life instrument
    Median survival
    Median survival
    Overall survival
    Survival

    Full Information

    First Posted
    January 6, 2016
    Last Updated
    June 5, 2017
    Sponsor
    AHS Cancer Control Alberta
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03175146
    Brief Title
    A Study to See Whether Stereotactic Body RadioTherapy (SBRT) Can Shrink Tumours Within the Liver Safely
    Official Title
    Stereotactic Body RadioTherapy (SBRT) for Oligo-metastatic Colo-rectal Cancer With Bio-marker Evaluation for Early Progression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2017 (Anticipated)
    Primary Completion Date
    January 2021 (Anticipated)
    Study Completion Date
    January 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AHS Cancer Control Alberta

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colonic Neoplasms, Neoplasm Metastasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    Stereotactic Body Radiation Therapy
    Intervention Type
    Radiation
    Intervention Name(s)
    Stereotactic Body Radiation Therapy
    Other Intervention Name(s)
    SBRT
    Intervention Description
    5 treatments given over 2 weeks
    Primary Outcome Measure Information:
    Title
    Response rate within the treated liver lesion
    Description
    RECIST Response
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Progression-free survival
    Description
    Any progression of the disease
    Time Frame
    Up to 5 years
    Title
    Toxicity
    Description
    Grade 3 CTCAE events
    Time Frame
    From date of randomization up to 5 years
    Title
    Quality of Life
    Description
    Fact - H quality of life instrument
    Time Frame
    From date of Randomization to Death or Progression or 5 years whichever comes first.
    Title
    Median survival
    Description
    Median survival
    Time Frame
    From date of randomization upto 5 years
    Title
    Overall survival
    Description
    Survival
    Time Frame
    From date of randomization upto 5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Richie Sinha, MD
    Phone
    403-476-2601
    Email
    richie.sinha@ahs.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richie Sinha, MD
    Organizational Affiliation
    Tom Baker Cancer Centre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

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

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