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Intensive Pre-Operative Radiotherapy for Soft Tissue Sarcoma (PRESTO Trial)

N/A
Recruiting
Led By Fabio Cury, MD
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG 0-2 (or Karnofsky Performance Status ≥ 70) within 60 days prior to registration
No previous radiation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

PRESTO Trial Summary

This trial is investigating whether a shorter, more intensive course of radiation therapy before surgery is as effective as the standard course of radiation therapy for people with soft tissue sarcomas.

Who is the study for?
This trial is for adults over 18 with a specific type of cancer called soft tissue sarcoma, located above the knee or in the trunk. Candidates must have a tumor that can be surgically removed, no prior radiation therapy, and an ECOG score of 0-2 indicating they are relatively active. They cannot participate if they have other cancers (except certain skin cancers), lymph node involvement by cancer, previous radiation in the area to be treated, or major illnesses.Check my eligibility
What is being tested?
The study is testing hypofractionated radiotherapy as pre-operative treatment for soft tissue sarcomas. This approach uses larger doses of radiation per session but fewer sessions overall compared to traditional methods. The goal is to deliver a higher effective dose more quickly and potentially reduce delays before surgery and wound complications.See study design
What are the potential side effects?
Potential side effects from hypofractionated radiotherapy may include skin irritation at the treatment site, fatigue due to high doses of radiation, swelling or pain around the affected area, and possibly delayed wound healing post-surgery.

PRESTO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been active and mostly self-sufficient in the last 2 months.
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I have not had any radiation therapy before.
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My cancer is a soft tissue sarcoma located in my limbs, above my knee, or trunk, confirmed by a pathologist.
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I am 18 years old or older.
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My doctors agree I should have radiation and surgery before other treatments.
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I am available for treatment and follow-up appointments.
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My cancer is either new or has come back in the same area, and I haven't had an accidental removal of it.
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My cancer can be surgically removed, with or without spread to distant areas.
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My cancer lesion is smaller than 15cm at its largest point.

PRESTO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acute RadiationToxicity using Common Terminology Criteria for Adverse Events (CTCAE) V.5
Secondary outcome measures
Physicians Muscle Tumor Rating Scale

PRESTO Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental : Short Course Pre-operative RadiothErapyExperimental Treatment1 Intervention
As part of the planning process, you need to undergo a CT Simulation.It is special type of CT scan used to measure and design the radiation fields to precisely target the tumor.It is done at the Radiation Oncology Department at the MUHC. Some patients may be asked to also undergo an MRI Simulation, and the CT simulation. You may asked to provide a blood sample to ensure good kidney function prior to the CT and MRI scans. Both CT and MRI simulations are considered standard of care. Once the simulation studies are done, there is about a 2 week waiting period for radiation planning prior to starting the radiation treatments. The hypofractionation technique will be delivering five fractions (one fraction delivered every 2nd day) of 7 Gy daily of external beam radiotherapy (EBRT) over a period of one and half weeks for a total of 35 Gy. The treatment should last approximately 30 minutes. Once treatments are done, there is a 4 to 6 week wait for surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionation
2017
Completed Phase 2
~460

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
442 Previous Clinical Trials
159,159 Total Patients Enrolled
Fabio Cury, MDPrincipal InvestigatorResearch Institute of McGill University Health Centre
1 Previous Clinical Trials
12 Total Patients Enrolled

Media Library

Hypofractionation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04617327 — N/A
Soft Tissue Sarcoma Research Study Groups: Experimental : Short Course Pre-operative RadiothErapy
Soft Tissue Sarcoma Clinical Trial 2023: Hypofractionation Highlights & Side Effects. Trial Name: NCT04617327 — N/A
Hypofractionation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04617327 — N/A

Frequently Asked Questions

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

Are participants still welcome to join this clinical experimentation?

"This medical experiment is still recruiting patients, as reflected in the details hosted on clinicaltrials.gov. It was initially listed on June 5th 2020 and most recently edited September 6th 2022."

Answered by AI

How many subjects are participating in this medical experiment?

"Verified. According to the information on clinicaltrials.gov, this research project is recruiting participants after being first posted in June 2020. The study's last update was in September 2022 and it is enlisting 15 patients across one site."

Answered by AI
~2 spots leftby Jan 2025