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Radiation Therapy
SABR Techniques for Metastatic Disease
N/A
Waitlist Available
Led By Robert 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately at the end of year 5 of follow-up, at study completion
Awards & highlights
Study Summary
This trial compares SABR radiation therapy techniques (single vs. multiple fraction) to measure toxicity, progression-free survival, quality of life & cost-effectiveness. In some cases, patient outcomes will be compared between those who receive guidance & those who don't.
Who is the study for?
Adults (18+) with 1-5 oligometastatic or progressing lesions, a controlled primary tumor, and no recent malignant cancers. They must be able to undergo immobilization for SABR treatment, have a life expectancy over 6 months, and complete questionnaires. Excluded are those with serious comorbidities affecting radiotherapy safety, large brain metastases (>3.5 cm), spinal cord compression without resection, pregnant/breastfeeding individuals, or if all disease sites can't be treated.Check my eligibility
What is being tested?
The trial compares single fraction versus multiple fraction Stereotactic Ablative Radiotherapy (SABR) in terms of side effects, progression-free survival, quality of life (QoL), and cost-effectiveness. It also assesses the impact on QoL and healthcare costs when patients report symptoms for provider intervention versus only completing QoL questionnaires.See study design
What are the potential side effects?
Potential side effects from SABR may include damage to nearby healthy tissues leading to inflammation or pain; fatigue; skin reactions like redness or irritation at the treatment site; possible worsening of underlying conditions such as lung disease if thoracic radiation is involved.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately at the end of year 5 of follow-up, at study completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately at the end of year 5 of follow-up, at study completion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events
Change in patient-reported quality of life
Secondary outcome measures
Lesional control rate
Overall survival
Progression-free survival
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Single fraction SABR (Arm 2)Experimental Treatment1 Intervention
Participants randomized to this arm will receive single fraction SABR
Group II: QoL reporting and healthcare provider (HCP) intervention guided by symptom screen (Arm B)Experimental Treatment1 Intervention
Patients complete EQ-5D-5L and FACT-G prior to each scheduled FU
Patient complete online adaptive symptom screen with HCP intervention, prior to each scheduled appointment
Group III: Multiple fraction SABR (Arm 1)Active Control1 Intervention
Participants randomized to this arm will receive multiple fraction SABR
Group IV: Patient-reported outcome (PRO) collection : QoL reporting alone (Arm A)Active Control1 Intervention
Participants will complete the EuroQoL-5Dimensions-5levels (EQ-5D-5L) and Functional Assessment of Cancer Therapy-General (FACT-G) prior to each scheduled follow-up (FU).
Find a Location
Who is running the clinical trial?
British Columbia Cancer AgencyLead Sponsor
171 Previous Clinical Trials
89,913 Total Patients Enrolled
London Regional Cancer Program, CanadaOTHER
10 Previous Clinical Trials
680 Total Patients Enrolled
Tom Baker Cancer CentreOTHER
29 Previous Clinical Trials
8,257 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- All my cancer spread (metastases) has been surgically removed.I need surgery to relieve pressure in my brain from cancer.My spine is considered unstable due to cancer.I have signs of pressure on my spinal cord.I can stay still during treatments.My cancer has spread but cannot be treated at all sites.My current treatment area has been radiated before.I am 18 years old or older.I need surgery to fix a bone in my thigh.My liver cancer is in a critical area.I am able to care for myself and perform daily activities.I can stay still in a device needed for my treatment.I have serious health issues that prevent me from receiving radiotherapy.I have not used chemotherapy drugs recently.My cancer has spread, and this was confirmed by tests.My cancer has spread to 1-5 specific areas.My primary cancer has not grown or spread.I do not have any other cancer that is growing or spreading.I have fluid buildup due to cancer in the lining of my lung.
Research Study Groups:
This trial has the following groups:- Group 1: Multiple fraction SABR (Arm 1)
- Group 2: Single fraction SABR (Arm 2)
- Group 3: Patient-reported outcome (PRO) collection : QoL reporting alone (Arm A)
- Group 4: QoL reporting and healthcare provider (HCP) intervention guided by symptom screen (Arm B)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are volunteers able to enlist in this clinical trial at the moment?
"Data hosted on clinicaltrials.gov reports that this medical trial, initially published in June of 2023, is no longer recruiting. Nevertheless, there are still 273 other trials actively seeking participants."
Answered by AI
Are there a plurality of locations hosting this clinical research in the same state?
"At present, this research project is administered in 5 locations: Prince George, Surrey and Vancouver as well as 2 other centres. To reduce travel demands for those who sign up for the trial, it's recommended to pick a site near you."
Answered by AI
What is the ultimate goal of this research endeavor?
"The primary outcome of this medical trial, which will be monitored at intervals over five years, is the alteration in patient-reported quality of life. As secondary objectives, researchers are assessing progression-free survival (time between randomisation and disease progression or death), overall survival rate (time from randomization to death) and resource utilization (hospital visits and treatments post SABR therapy)."
Answered by AI
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