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Surveillance Strategies After Surgery for Soft Tissue Sarcoma (SAFETY Trial)

N/A
Recruiting
Led By Michelle Ghert, MD
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
Must not have
The patient has metastases at initial presentation based on the radiology report of the initial thoracic imaging†
The patient has been diagnosed with one of the special sub-types, myxoid / round cell liposarcoma or extra-skeletal Ewing's sarcoma*
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My initial scans showed that my cancer has spread.
Select...
I have been diagnosed with myxoid/round cell liposarcoma or extra-skeletal Ewing's sarcoma.
Select...
I recently had surgery to remove a cancer that came back in the same place.
Select...
I have a health condition that may shorten my life to under a year.
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My current treatment plan doesn't allow regular full-body PET scans.
Select...
I have a genetic condition like Li-Fraumeni Syndrome that increases my cancer risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival
Secondary study objectives
Local Recurrence-Free Survival
Metastasis-Free Survival
Net Healthcare Costs
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
916 Previous Clinical Trials
2,615,028 Total Patients Enrolled
Hamilton Academic Health Sciences OrganizationOTHER
21 Previous Clinical Trials
4,844 Total Patients Enrolled
Michelle Ghert, MDPrincipal InvestigatorMcMaster University

Media Library

Frequency: Every 6 Months Clinical Trial Eligibility Overview. Trial Name: NCT03944798 — N/A
Soft Tissue Sarcoma Research Study Groups: Surveillance Arm I, Surveillance Arm II, Surveillance Arm III, Surveillance Arm IV
Soft Tissue Sarcoma Clinical Trial 2023: Frequency: Every 6 Months Highlights & Side Effects. Trial Name: NCT03944798 — N/A
Frequency: Every 6 Months 2023 Treatment Timeline for Medical Study. Trial Name: NCT03944798 — N/A
~109 spots leftby Dec 2030
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