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Radiation Therapy

Postoperative intensity modulated radiation therapy for Soft Tissue Sarcoma

Phase 3

Waitlist Available

Led By Peter Chung, MD

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ surgery date until 5 years postoperative or death, whichever occurs first

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of acute wound healing complications

Secondary outcome measures

Acute Radiation Toxicity

Late Radiation Toxicity- Common Toxicity Criteria

Late Radiation Toxicity- Limb Edema

+6 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mount Sinai Hospital, CanadaLead Sponsor

196 Previous Clinical Trials

67,398 Total Patients Enrolled

Princess Margaret Hospital, CanadaOTHER

119 Previous Clinical Trials

38,849 Total Patients Enrolled

Peter Chung, MDPrincipal InvestigatorPrincess Margaret Cancer Centre

3 Previous Clinical Trials

116 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned the use of Postoperative intensity modulated radiation therapy?

"3."

Answered by AI

Is this study widespread throughout the state?

"Patients are being recruited from Cleveland Clinic Taussig Cancer Institute in Cleveland, Ohio, Oregon Health & Science University in Portland, Oregon, Princess Margaret Cancer Centre in Toronto, Ontario, and 7 other locations."

Answered by AI

How many people are currently taking part in this experiment?

"In order to properly run this clinical trial, 206 patients that meet the pre-determined inclusion criteria are needed. These participants can choose to take part in the trial at Cleveland Clinic Taussig Cancer Institute or Oregon Health & Science University."

Answered by AI

Are people with the target condition able to enroll in this trial today?

"That is accurate. The website clinicaltrials.gov has the latest information on this trial, which is currently recruiting patients. The study was originally posted on 2016-06-01 and was most recently edited on 2020-09-10. 206 individuals are needed for the trial and they will be coming from 7 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Preoperative vs Postoperative IMRT for Extremity/Truncal STS

2016. "Preoperative vs Postoperative IMRT for Extremity/Truncal STS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02565498.

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