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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
Patient has had CT or MRI brain imaging if primary has a propensity for CNS metastasis within 8 weeks prior to enrollment, and within 12 weeks prior to treatment(if randomized to SABR)
Controlled primary tumor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at approximately end of year 5 (study completion)
Awards & highlights

SABR-COMET-3 Trial 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.Check my eligibility
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.See study design
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.

SABR-COMET-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had a brain scan within the last 8 weeks to check for cancer spread.
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My primary cancer is under control.
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I currently have 1 to 3 cancer spread sites and no more than 8 in my lifetime.
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I am 18 years old or older.
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I've had a physical exam and my activity level checked within the last 6 weeks.
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I am 18 years old or older.
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My cancer has spread, and this was confirmed by tests.
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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 can stay still during treatments.
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I am able to get out of my bed or chair and move around.
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I've had a CT or PET-CT scan of my chest, abdomen, and pelvis within the last 8 weeks.
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I've had a bone scan within 8 weeks before joining, or 12 weeks if getting SABR.
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I am a woman who can have children and have a negative pregnancy test within the last 4 weeks.
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I've had specific scans within 8 weeks before joining the trial due to an unbiopsied lung nodule.
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I've had a PET scan within 8 weeks before joining the study due to uncertain imaging and rising cancer markers.
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It's been 3 months since my original cancer treatment, with no growth at the cancer's original location.
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I can use devices needed for my radiation treatment without discomfort.
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I am able to get out of my bed or chair and move around.

SABR-COMET-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at approximately end of year 5 (study completion)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at approximately end of year 5 (study completion) for reporting.

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 more

SABR-COMET-3 Trial 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?

Riverina Cancer Care CentreUNKNOWN
Walker Family Cancer CentreUNKNOWN
Cancer Research UK Edinburgh CentreUNKNOWN
1 Previous Clinical Trials
221 Total Patients Enrolled

Media Library

Stereotactic Ablative Radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03862911 — N/A
Cancer Research Study Groups: Standard of Care Treatment (Arm 1), Stereotactic Arm (Arm 2)
Cancer Clinical Trial 2023: Stereotactic Ablative Radiotherapy Highlights & Side Effects. Trial Name: NCT03862911 — N/A
Stereotactic Ablative Radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03862911 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many distinct locations is this clinical experiment being handled in?

"Participants can join this research trial at BC Cancer - Prince George, Kelowna (BC), Walker Family Cancer Centre in Saint Catharines (NS) as well as 9 other medical centres."

Answered by AI

Is there room to accommodate further participants in this experiment?

"Clinicaltrials.gov affirms that this medical trial is accepting participants, with the initial advertisement posted on November 1st 2019 and most recently updated June 28th 2022."

Answered by AI

How many individuals are actively engaged in this investigative endeavor?

"A total of 330 participants, who satisfy the listed qualifications, are needed to successfully complete this trial. Patients can opt-in at either BC Cancer - Prince George in Prince George or BC Cancer in Kelowna."

Answered by AI

Who else is applying?

What state do they live in?
Nova Scotia
How old are they?
18 - 65
What site did they apply to?
Nova Scotia Cancer Centre
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
~170 spots leftby Dec 2028