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

Sponsor
AHS Cancer Control Alberta (Other)
Overall Status
Unknown status
CT.gov ID
NCT03175146
Collaborator
(none)
30
Enrollment
1
Arm
40
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: Stereotactic Body Radiation Therapy
 N/A

Detailed Description

SBRT for Oligo-metastatic Colorectal cancer

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Stereotactic Body RadioTherapy (SBRT) for Oligo-metastatic Colo-rectal Cancer With Bio-marker Evaluation for Early Progression
Anticipated Study Start Date :
Sep 1, 2017
Anticipated Primary Completion Date :
Jan 1, 2021
Anticipated Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental

Stereotactic Body Radiation Therapy

Radiation: Stereotactic Body Radiation Therapy
5 treatments given over 2 weeks
Other Names:
  • SBRT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Response rate within the treated liver lesion [6 months]

      RECIST Response

    Secondary Outcome Measures

    1. Progression-free survival [Up to 5 years]

      Any progression of the disease

    2. Toxicity [From date of randomization up to 5 years]

      Grade 3 CTCAE events

    3. Quality of Life [From date of Randomization to Death or Progression or 5 years whichever comes first.]

      Fact - H quality of life instrument

    4. Median survival [From date of randomization upto 5 years]

      Median survival

    5. Overall survival [From date of randomization upto 5 years]

      Survival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AHS Cancer Control Alberta

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AHS Cancer Control Alberta
    ClinicalTrials.gov Identifier:
    NCT03175146
    Other Study ID Numbers:
    • CRC L-SBRT 15-01
    First Posted:
    Jun 5, 2017
    Last Update Posted:
    Jun 7, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms
    Neoplasm Metastasis
    Colonic Neoplasms

    Study Results

    No Results Posted as of Jun 7, 2017