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Radiation Therapy

IMRT for Soft Tissue Sarcoma

Phase 3
Waitlist Available
Led By Peter Ferguson, MD, FRCSC
Research Sponsored by Mount Sinai Hospital, Canada
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 surgery date until 5 years postoperative or death, whichever occurs first
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare the short-term wound healing complications of patients with extremity or truncal soft tissue sarcoma who receive preoperative image guided radiation therapy (IGRT) delivered using intensity modulated radiation therapy (IMRT) to those who receive surgery followed by postoperative IGRT.

Who is the study for?
This trial is for adults over 18 with soft tissue sarcoma in the limbs or torso, who are fit enough for surgery and radiotherapy. They must have a tumor that's either new or has come back after treatment. Patients should be able to consent to treatment and follow-up, and have an ECOG score between 0-3.
What is being tested?
The study compares two approaches using IMRT: one where patients get radiation before surgery (preoperative) and another where they get it after (postoperative). The goal is to see which method leads to fewer wound healing complications shortly after surgery.
What are the potential side effects?
IMRT may cause side effects such as skin irritation, fatigue, swelling at the treatment site, and potential delays in wound healing. There might also be risks associated with anesthesia during surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~surgery date until 5 years postoperative or death, whichever occurs first
This trial's timeline: 3 weeks for screening, Varies for treatment, and surgery date until 5 years postoperative or death, whichever occurs first for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of acute wound healing complications
Secondary study objectives
Acute Radiation Toxicity
Late Radiation Toxicity- Common Toxicity Criteria
Late Radiation Toxicity- Limb Edema
+6 more

Awards & Highlights

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.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Preoperative Radiation Therapy (Arm A)Experimental Treatment1 Intervention
Preoperative intensity modulated radiation therapy followed by surgery
Group II: Postoperative Radiation Therapy (Arm B)Experimental Treatment1 Intervention
Surgery followed by postoperative intensity modulated radiation therapy

Find a Location

Who is running the clinical trial?

Mount Sinai Hospital, CanadaLead Sponsor
203 Previous Clinical Trials
69,038 Total Patients Enrolled
Princess Margaret Hospital, CanadaOTHER
119 Previous Clinical Trials
38,858 Total Patients Enrolled
Peter Ferguson, MD, FRCSCPrincipal InvestigatorMOUNT SINAI HOSPITAL
Peter Chung, MDPrincipal InvestigatorPrincess Margaret Cancer Centre
3 Previous Clinical Trials
116 Total Patients Enrolled
~22 spots leftby Dec 2025
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