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Radiation Therapy
Stereotactic Ablative Radiotherapy for Cancer (SABR-COMET Trial)
Phase 2
Waitlist Available
Led By Suresh Senan, MRCPFRCR,PhD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status 0-1
Controlled primary tumor defined as at least 3 months since original tumor treated definitively, with no progression at primary site
Must not have
Serious medical comorbidities precluding radiotherapy
Prior radiotherapy to a site requiring treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare a new, more precise radiation treatment to chemotherapy and older radiation treatments to see if it improves survival and quality of life.
Who is the study for?
This trial is for adults over 18 with a life expectancy of more than 6 months and confirmed metastatic cancer. They should have had no systemic therapy in the month before radiotherapy, be able to consent, and have an ECOG performance status of 0-1. All cancer sites must be treatable with SABR, which excludes those with certain brain or bone metastases or previous treatments like surgery that can't be followed by SABR.
What is being tested?
The study compares Stereotactic Ablative Radiotherapy (SABR), a precise high-dose radiation treatment given over 1-3 weeks, to conventional chemotherapy and radiotherapy. It aims to see if SABR offers better control of cancer with fewer side effects, thus improving survival rates and quality of life.
What are the potential side effects?
Potential side effects include typical reactions associated with radiation such as skin irritation at the treatment site, fatigue, nausea, potential damage to nearby organs depending on where the tumors are located, but these may be reduced due to SABR's precision.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My original cancer site has been stable for at least 3 months after treatment.
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I have no more than 3 cancer spread spots in any one organ.
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I am not a candidate for surgery to remove my cancer according to my medical team.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have health conditions that prevent me from receiving radiotherapy.
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I have had radiation therapy on the area that now needs treatment.
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My first chemotherapy fully eliminated the cancer that can be measured.
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I have fluid buildup due to cancer in the lining of my lung.
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All my cancer sites cannot be treated.
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I need surgery to relieve pressure in my brain from cancer.
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My MRI shows a tumor near my spinal cord or evidence of spinal cord compression.
Select...
My cancer has spread to the bone in my thigh.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Stereotactic armExperimental Treatment1 Intervention
Stereotactic ablative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist
Group II: Standard armActive 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?
Lawson Health Research InstituteLead Sponsor
677 Previous Clinical Trials
421,528 Total Patients Enrolled
London Regional Cancer Program, CanadaOTHER
10 Previous Clinical Trials
1,179 Total Patients Enrolled
VU University of AmsterdamOTHER
99 Previous Clinical Trials
91,422 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any cancer treatment in the last 4 weeks.My treated cancer spread is under control, or if not, it can be treated with SABR after surgery.I have health conditions that prevent me from receiving radiotherapy.My cancer has spread, and imaging tests have confirmed this.I am fully active or can carry out light work.My original cancer site has been stable for at least 3 months after treatment.I have 1-3 brain tumors and no cancer in other parts of my body.I have had radiation therapy on the area that now needs treatment.I have no more than 3 cancer spread spots in any one organ.I am not a candidate for surgery to remove my cancer according to my medical team.My case was reviewed by a team of cancer specialists.My first chemotherapy fully eliminated the cancer that can be measured.I have fluid buildup due to cancer in the lining of my lung.All my cancer sites cannot be treated.I need surgery to relieve pressure in my brain from cancer.My MRI shows a tumor near my spinal cord or evidence of spinal cord compression.All my cancer sites can be safely treated.My cancer has spread to the bone in my thigh.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Stereotactic arm
- Group 2: Standard arm
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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