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Radiation Therapy
SABR for Oligometastatic Cancer (SABR-COMET-3 Trial)
N/A
Recruiting
Led By Robert A Olson, MD, MSc, FRCPC
Research Sponsored by British Columbia Cancer Agency
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Controlled primary tumor
Age 18 or older
Must not have
Lesion in femoral bone requiring surgical fixation
Dominant brain metastasis requiring surgical decompression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at approximately end of year 5 (study completion)
Awards & highlights
Summary
This trial will compare the effectiveness of a new radiation therapy technique called SABR to the current standard of care for treating people with cancer that has spread to other parts of the body.
Who is the study for?
This trial is for adults with a limited number of cancer metastases (1-3 currently, up to 8 in their lifetime). They must have controlled primary tumors, be able to hold still during treatment, and not be pregnant. Excluded are those with concurrent cancers within the last 5 years, certain organ dysfunctions or large brain metastases.
What is being tested?
The study compares Stereotactic Ablative Radiotherapy (SABR), a high-dose radiation therapy targeting small tumor areas non-invasively on an outpatient basis, against standard palliative care. It will assess survival rates, side effects, quality of life and cost-effectiveness.
What are the potential side effects?
Potential side effects include skin reactions at the treatment site, fatigue, nausea or vomiting depending on the area treated. There may also be risks specific to the organs near where SABR is administered such as lung inflammation if treating near lungs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My primary cancer is under control.
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I am 18 years old or older.
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I have 1 to 3 current cancer spread sites and no more than 8 in my lifetime.
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My cancer cannot be removed by surgery or I chose not to have surgery.
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I am able to get out of my bed or chair and move around.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need surgery to fix a bone in my thigh.
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I need surgery to relieve pressure in my brain from cancer spread.
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Not all areas of my cancer can be treated.
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I cannot have radiotherapy due to serious health conditions like lung disease, Crohn's, lupus, or scleroderma.
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I have fluid buildup due to cancer in the lining of my lung.
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I have not had cancer in the last 5 years, except for non-melanoma skin cancer.
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I have a brain tumor larger than 3 cm or total brain tumors over 30 cc in volume.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at approximately end of year 5 (study completion)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at approximately end of year 5 (study completion)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival
Secondary outcome measures
Correlation between candidate biomarkers of oligometastatic disease (blood-derived) and oncologic outcomes
Health-related quality of life (HRQoL) questionnaire
Patient-reported quality of life (QoL)
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Stereotactic Arm (Arm 2)Experimental Treatment1 Intervention
Stereotactic ablative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist
Group II: Standard of Care Treatment (Arm 1)Active Control1 Intervention
Standard of care, palliative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic ablative radiotherapy
2012
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
Bon Secours Cork Cancer CentreUNKNOWN
Walker Family Cancer CentreUNKNOWN
Cancer Research UK Edinburgh CentreUNKNOWN
1 Previous Clinical Trials
221 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need surgery to fix a bone in my thigh.I've had a brain scan within the last 8 weeks to check for cancer spread.I have or had a tumor close to my spinal cord, but if removed, it's part of my 8 lifetime metastases limit.My primary cancer is under control.I am 18 years old or older.I've had a physical exam and my activity level checked within the last 6 weeks.My original cancer has been stable for at least 3 months after treatment.My cancer has spread, and this was confirmed by tests.I need surgery to relieve pressure in my brain from cancer spread.Not all areas of my cancer can be treated.I have not used chemotherapy drugs 2 weeks before to 1 week after my specific radiation treatment.I have 1 to 3 current cancer spread sites and no more than 8 in my lifetime.My cancer cannot be removed by surgery or I chose not to have surgery.I cannot have radiotherapy due to serious health conditions like lung disease, Crohn's, lupus, or scleroderma.I can stay still during treatments.I have had liver problems in the past.I have had issues with my lung function in the past.I have had radiation before, but it doesn't heavily overlap with the area to be treated now.I am able to get out of my bed or chair and move around.I have fluid buildup due to cancer in the lining of my lung.I've had a CT or PET-CT scan of my chest, abdomen, and pelvis within the last 8 weeks.I've had a bone scan within 8 weeks before joining, or 12 weeks if getting SABR.My cancer outside the brain has lesions no larger than 5 cm, except for some bone metastases.I am a woman who can have children and have a negative pregnancy test within the last 4 weeks.I have not had cancer in the last 5 years, except for non-melanoma skin cancer.I have a brain tumor larger than 3 cm or total brain tumors over 30 cc in volume.I've had specific scans within 8 weeks before joining the trial due to an unbiopsied lung nodule.I've had a PET scan within 8 weeks before joining the study due to uncertain imaging and rising cancer markers.It's been 3 months since my original cancer treatment, with no growth at the cancer's original location.I can use devices needed for my radiation treatment without discomfort.You are expected to live for at least 6 more months.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care Treatment (Arm 1)
- Group 2: Stereotactic Arm (Arm 2)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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