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Radiation Therapy
SABR for Oligometastatic Cancer (SABR-COMET 10 Trial)
Phase 3
Waitlist Available
Led By David Palma, MD
Research Sponsored by David Palma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All sites of disease can be safely treated based on a pre-plan
Karnofsky performance score greater than 60
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of years 1, 2, 3, 4, 5, and 6 (study completion)
Awards & highlights
SABR-COMET 10 Trial Summary
This trial is testing whether a treatment called SABR, which destroys cancer cells, is better than the standard treatment for people who have a limited spread of cancer.
Who is the study for?
This trial is for adults with cancer that has spread to 4-10 places but isn't widespread. They must have had their original tumor controlled for at least 3 months, be able to undergo treatment safely, and have a life expectancy over 6 months. It's not for those with large tumors in certain areas, brainstem involvement, spinal cord compression, or serious health issues that radiotherapy could worsen.Check my eligibility
What is being tested?
The study tests if Stereotactic Ablative Radiotherapy (SABR) can improve survival and quality of life compared to standard treatments like chemotherapy or observation in patients with limited metastatic cancer. Participants will either receive SABR or the standard care to see which is more effective.See study design
What are the potential side effects?
Potential side effects from SABR may include skin reactions, fatigue, pain at the treatment site, nausea and potential damage to nearby organs depending on where the radiation is targeted. The severity varies by individual.
SABR-COMET 10 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
All my cancer areas can be safely treated.
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I can care for myself but may need occasional help.
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I have between 4 to 10 cancer spread sites.
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I am 18 years old or older.
SABR-COMET 10 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of years 1, 2, 3, 4, 5, and 6 (study completion)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of years 1, 2, 3, 4, 5, and 6 (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 at Study Completion
Secondary outcome measures
Overall Survival at midpoint of Study
Progression-free Survival
Quality of Life as measured by the EuroQOL Group EQ-5D-5L questionnaire
+3 moreSABR-COMET 10 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Stereotactic ArmExperimental Treatment5 Interventions
Stereotactic ablative radiotherapy, plus standard of care treatment: chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist.
Group II: Standard armActive Control5 Interventions
Standard of care treatment: palliative radiotherapy, chemotherapy, immunotherapy, hormones, or observation, is at the discretion of the treating oncologist.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemotherapy
2003
Completed Phase 4
~3050
Immunotherapy
2016
Completed Phase 4
~1270
Hormones
2011
N/A
~80
Find a Location
Who is running the clinical trial?
Amsterdam University Medical Centre, VUmc SiteUNKNOWN
British Columbia Cancer - Centre for the NorthUNKNOWN
David PalmaLead Sponsor
2 Previous Clinical Trials
228 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- All my cancer areas can be safely treated.My cancer has spread to my digestive system, certain lymph nodes, or skin.My cancer has spread to the brainstem.I need surgery to relieve pressure in my brain from cancer.I can care for myself but may need occasional help.I have had radiation before, but it doesn't overlap much with the new treatment area.Not all areas of my cancer can be treated.My original cancer site has been stable for at least 3 months after treatment.My liver is not working well due to cancer spread.I cannot have radiotherapy due to serious health conditions like lung disease, Crohn's, lupus, or scleroderma.I have between 4 to 10 cancer spread sites.My brain metastasis is larger than 3 cm or the total volume is over 30 cc.I have signs of pressure on my spinal cord.I have a tumor larger than 5 cm that has spread.I am 18 years old or older.My cancer has spread, and this was confirmed by tests.I have fluid buildup due to cancer in the lining of my lung.
Research Study Groups:
This trial has the following groups:- Group 1: Stereotactic Arm
- Group 2: Standard arm
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients currently being recruited for this clinical trial?
"The trial is recruiting for 204 patients at 8 locations, as stated on clinicaltrials.gov."
Answered by AI
At how many different locations can people participate in this trial?
"In addition to BC Cancer Agency, Vancouver Island Centre in Victoria, British Columbia, Nova Scotia Health Authortiy in Halifax, Nova Scotia, and Niagra Health System in St. Catharines, Quebec, this clinical trial is also enrolling patients at 8 other locations."
Answered by AI
Could you please enumerate the risks associated with Chemotherapy?
"Chemotherapy is a commonly used cancer treatment with a high success rate. It is typically considered safe, with few side effects."
Answered by AI
How many individuals are part of this clinical trial?
"In total, this clinical trial needs 204 patients that meet the specific inclusion criteria. If patients are willing and eligible, they can participate in this study at different locations like BC Cancer Agency in Vancouver, Victoria Island Centre in Victoria, British Columbia, and Nova Scotia Health Authority in Halifax, Nova Scotia."
Answered by AI
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