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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 during year 6 (follow-up year).
Awards & highlights
SABR-SYNC Trial Summary
This trial compares current standard cancer treatments to a new treatment, SABR, to see which is more effective in treating cancer.
Who is the study for?
This trial is for adults with 1-10 metastases and a primary tumor, who have had recent restaging, confirmed metastatic cancer, can consent, have a good performance status and life expectancy over 6 months. Not eligible if pregnant, severe liver dysfunction or medical conditions that preclude radiotherapy like ILD or Crohn's disease.Check my eligibility
What is being tested?
The study compares standard cancer care treatments to the same treatments plus SABR (a type of precise high-dose radiation therapy) on known disease sites. Patients are grouped by cancer type and number of metastases and randomly assigned in a 1:2 ratio to either treatment arm.See study design
What are the potential side effects?
Potential side effects include those common to radiotherapy such as skin irritation, fatigue, nausea; chemotherapy-related issues like hair loss, mouth sores; hormone therapy effects including mood swings; immunotherapy reactions like rashes or flu-like symptoms.
SABR-SYNC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during year 6 (follow-up year).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during year 6 (follow-up year).
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
Quality of Life (QOL) assessed with the Functional Assessment of Cancer Therapy: General (FACT-G).
Quality of Life (QOL) assessed with the Functional Assessment of Cancer Therapy: The EuroQol 5-Dimension 5-Level (EQ-5D-5L).
Receipt of additional radiation during follow-up
+2 moreSABR-SYNC Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Arm (Arm 2)Experimental Treatment10 Interventions
Consists of treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable (e.g. surgery, RFA, fractionated radiation, chemoradiation) if those are deemed to be preferable by the treating oncologists.
Group II: Standard Arm (Arm 1)Active Control6 Interventions
Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications.
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
Surgery
2000
Completed Phase 3
~2550
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Who is running the clinical trial?
David PalmaLead Sponsor
2 Previous Clinical Trials
252 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread, and this was confirmed by tests.My liver is not working well due to cancer spread.My cancer has spread to the brainstem.I cannot have radiotherapy due to conditions like ILD, Crohn's, ulcerative colitis, lupus, or scleroderma.I can care for myself but may not be able to do active work.I have fluid buildup due to cancer in the lining of my lung.My cancer cannot be treated at all its locations.I have 1 to 10 cancer spread sites and my original cancer tumor is still present.I am 18 years old or older.My treatment area has been radiated before.My brain tumor is larger than 3 cm or the total size of tumors in my brain is over 30 cc.I have signs or scans showing pressure on my spinal cord.My cancer has spread to my digestive system or skin.My doctor confirmed no signs of lung scarring on my CT scans before radiotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Arm (Arm 1)
- Group 2: Experimental Arm (Arm 2)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Has the FDA granted authorization for Experimental Arm (Arm 2)?
"Previous clinical documentation has provided evidence of Experimental Arm (Arm 2)'s safety, thus receiving a score of 3."
Answered by AI
Is it possible to sign up as a subject in this experiment?
"Clinicaltrials.gov indicates that this trial, posted on April 1st 2023 and last updated February 6th 2023, is not presently recruiting participants. However, there are currently 619 other clinical trials actively seeking patients."
Answered by AI
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