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Surveillance Strategies After Surgery for Soft Tissue Sarcoma (SAFETY Trial)
N/A
Recruiting
Led By Michelle Ghert, MD, FRCSC
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The tumor size is greater than or equal to (≥) five centimeters according to the pathology report or based on the pre-treatment MRI if neoadjuvant radiation and / or chemotherapy are given
The patient has undergone surgical excision of the tumor with curative intent and with no evidence of gross residual disease based on the pathology report
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
SAFETY Trial Summary
This trial will help determine if a more frequent or less frequent surveillance strategy for extremity STS patients after surgery impacts patient survival rates.
Who is the study for?
Adults over 18 who've had surgery for a large, high-grade soft-tissue sarcoma in an extremity without any remaining visible disease can join. They must have finished any radiation or chemo if it was part of their treatment and be able to consent. People with initial metastases, recent local recurrence surgeries, certain sarcoma subtypes, life expectancy under one year due to other diseases, incompatible surveillance protocols, enrollment in conflicting trials or genetic syndromes like Li-Freumeni are excluded.Check my eligibility
What is being tested?
The SAFETY trial is testing how often patients should get check-ups (every 3 vs. every 6 months) and what type of imaging (CT scans vs. chest radiographs) is best after surgery for extremity soft-tissue sarcoma. It aims to see which strategy helps survival rates the most without negatively affecting quality of life.See study design
What are the potential side effects?
There may not be direct side effects from participating as this trial involves monitoring strategies rather than medication or treatments; however, CT scans involve exposure to radiation which carries a small risk of causing cancer over time.
SAFETY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor is at least 5 cm large according to my latest tests.
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I had surgery to remove my cancer and the report shows no visible cancer left.
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I am 18 years old or older.
Select...
I have finished all my scheduled chemotherapy or radiation treatments.
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I have been diagnosed with a high-grade soft-tissue sarcoma in my arm or leg.
SAFETY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
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
Local Recurrence-Free Survival
Metastasis-Free Survival
Net Healthcare Costs
+4 moreSAFETY Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Surveillance Arm IVExperimental Treatment2 Interventions
Clinical assessment and chest CT every three months for two years
Group II: Surveillance Arm IIIExperimental Treatment2 Interventions
Clinical assessment and chest computed tomography (CT) every six months for two years
Group III: Surveillance Arm IIExperimental Treatment2 Interventions
Clinical assessment and CXR every three months for two years
Group IV: Surveillance Arm IActive Control2 Interventions
Clinical assessment and chest radiograph (CXR) every six months for two years
Find a Location
Who is running the clinical trial?
McMaster UniversityLead Sponsor
884 Previous Clinical Trials
2,598,116 Total Patients Enrolled
Hamilton Academic Health Sciences OrganizationOTHER
20 Previous Clinical Trials
4,666 Total Patients Enrolled
Michelle Ghert, MD, FRCSCPrincipal InvestigatorMcMaster University
1 Previous Clinical Trials
602 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor is at least 5 cm large according to my latest tests.I had surgery to remove my cancer and the report shows no visible cancer left.I have a genetic condition that increases my cancer risk, so I limit CT scans.My initial scans showed that my cancer has spread.I have been diagnosed with myxoid/round cell liposarcoma or extra-skeletal Ewing's sarcoma.I recently had surgery to remove a cancer that came back in the same place.I have a health condition that may shorten my life to under a year.My current treatment plan doesn't allow regular full-body PET scans.I may need a second CT scan to prove my lung nodules aren't cancer.I am 18 years old or older.I have finished all my scheduled chemotherapy or radiation treatments.I have been diagnosed with a high-grade soft-tissue sarcoma in my arm or leg.I have a genetic condition like Li-Fraumeni Syndrome that increases my cancer risk.My cancer type requires unique follow-up care due to its spread pattern.
Research Study Groups:
This trial has the following groups:- Group 1: Surveillance Arm I
- Group 2: Surveillance Arm II
- Group 3: Surveillance Arm III
- Group 4: Surveillance Arm IV
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 there any additional opportunities to participate in this research initiative?
"Affirmative. According to the info on clinicaltrials.gov, this research project is actively recruiting participants as of October 4th 2022 - nearly two and a half years after it was first advertised in November 2019. 200 individuals are needed from 20 different medical institutions for full participation."
Answered by AI
What is the projected enrollment for this trial?
"Affirmative. The information hosted on clinicaltrials.gov declares that this medical trial is currently seeking participants, having first been posted on November 19th 2019 and last amended October 4th 2022. 200 individuals are sought from 20 different sites."
Answered by AI
Is this research experiment being conducted in various locations across the US?
"This clinical trial is enrolling patients at The Ottawa Hospital, Nova Scotia Health in Halifax, and Hartford Healthcare in Indiana. Additionally, there are 20 other recruitment sites throughout the United States of America."
Answered by AI
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