Your session is about to expire
← Back to Search
Other
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
No previous radiation therapy
Histologically proven STS of the extremities, above the knee, or trunk following review by our pathologist
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 belowSelect...
I have not had any radiation therapy before.
Select...
My cancer is a soft tissue sarcoma located in my limbs, above my knee, or trunk, confirmed by a pathologist.
Select...
I am 18 years old or older.
Select...
My cancer is either new or has come back in the same area, and I haven't had an accidental removal of it.
Select...
My cancer can be surgically removed, with or without spread to distant areas.
Select...
My cancer lesion is smaller than 15cm at its largest point.
PRESTO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had radiation therapy on the area that needs treatment now.I have been active and mostly self-sufficient in the last 2 months.I have lesions below my knee.I have not had any radiation therapy before.My cancer is a soft tissue sarcoma located in my limbs, above my knee, or trunk, confirmed by a pathologist.I am 18 years old or older.My doctors agree I should have radiation and surgery before other treatments.I am available for treatment and follow-up appointments.I had an unexpected surgery to remove cancer at another hospital.My cancer has spread to nearby lymph nodes.My cancer is either new or has come back in the same area, and I haven't had an accidental removal of it.My cancer can be surgically removed, with or without spread to distant areas.I have been cancer-free for at least 5 years, except for non-melanoma skin cancer.My cancer lesion is smaller than 15cm at its largest point.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental : Short Course Pre-operative RadiothErapy
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 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
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger