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

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ClinicalTrials.gov Identifier: NCT03175146
Recruitment Status : Not yet recruiting
First Posted : June 5, 2017
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta

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
Colonic Neoplasms Neoplasm Metastasis Radiation: Stereotactic Body Radiation Therapy Not Applicable

Detailed Description:
SBRT for Oligo-metastatic Colorectal cancer

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
Experimental: Experimental
Stereotactic Body Radiation Therapy
Radiation: Stereotactic Body Radiation Therapy
5 treatments given over 2 weeks
Other Name: SBRT




Primary Outcome Measures :
  1. Response rate within the treated liver lesion [ Time Frame: 6 months ]
    RECIST Response


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Up to 5 years ]
    Any progression of the disease

  2. Toxicity [ Time Frame: From date of randomization up to 5 years ]
    Grade 3 CTCAE events

  3. 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

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

  5. Overall survival [ Time Frame: From date of randomization upto 5 years ]
    Survival



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03175146


Contacts
Contact: Richie Sinha, MD 403-476-2601 richie.sinha@ahs.ca

Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Richie Sinha, MD Tom Baker Cancer Centre

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT03175146     History of Changes
Other Study ID Numbers: CRC L-SBRT 15-01
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
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
Neoplastic Processes
Pathologic Processes
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases