15 Participants Needed

Intensive Pre-Operative Radiotherapy for Soft Tissue Sarcoma

(PRESTO Trial)

Fabio Cury, MD profile photo
Overseen ByFabio Cury, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new radiation treatment for patients with localized soft tissue sarcomas. The treatment uses higher doses of radiation to be more effective and quicker, potentially reducing surgery delays and complications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is hypofractionated radiotherapy safe for soft tissue sarcoma patients?

Research shows that hypofractionated radiotherapy, a shorter and more intense form of radiation treatment, is generally safe for patients with soft tissue sarcoma. Studies indicate that it does not increase the risk of side effects compared to traditional longer courses of radiotherapy, and it may even improve treatment adherence and cost-effectiveness.12345

How is hypofractionated radiotherapy different from other treatments for soft tissue sarcoma?

Hypofractionated radiotherapy for soft tissue sarcoma is unique because it involves delivering higher doses of radiation over a shorter period, typically in 5 sessions, compared to the conventional 5-week schedule. This approach may improve patient adherence, reduce costs, and offer more treatment opportunities without increasing side effects or compromising effectiveness.12345

What data supports the effectiveness of the treatment Intensive Pre-Operative Radiotherapy for Soft Tissue Sarcoma?

Research shows that using fewer, higher doses of radiation before surgery for soft tissue sarcoma can be effective without increasing side effects. This approach may improve treatment adherence and cost-effectiveness, making it a promising option for patients.34567

Who Is on the Research Team?

Fabio Cury | Gerald Bronfman Department ...

Fabio Cury, MD

Principal Investigator

Research Institute of McGill University Health Centre

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been active and mostly self-sufficient in the last 2 months.
I have not had any radiation therapy before.
Patient must be able to provide study-specific informed consent prior to study entry
See 6 more

Exclusion Criteria

I have had radiation therapy on the area that needs treatment now.
Other major medical illness deemed to preclude safe administration of protocol treatment or required follow-up
I have lesions below my knee.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment Evaluation

Standard pre-treatment evaluation including history, physical exam, radiology, and quality of life assessments

2 weeks
1 visit (in-person)

Radiation Treatment

Hypofractionated radiotherapy delivering five fractions of 7 Gy over one and a half weeks

1.5 weeks
5 visits (in-person)

Surgery

Surgery performed 4-6 weeks after completion of radiotherapy

4-6 weeks post-radiotherapy

Follow-up

Participants are monitored for acute and late toxicity, wound assessment, and quality of life

Up to 5 years
Multiple visits (in-person) at 1, 3, 6, 12, 18, 24 months, and yearly thereafter

What Are the Treatments Tested in This Trial?

Interventions

  • Hypofractionation
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Experimental : Short Course Pre-operative RadiothErapyExperimental Treatment1 Intervention

Hypofractionation is already approved in European Union, United States, Canada for the following indications:

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Approved in European Union as Hypofractionation for:
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Approved in United States as Hypofractionation for:
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Approved in Canada as Hypofractionation for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials
476
Recruited
170,000+

Published Research Related to This Trial

In a study of 16 patients with soft tissue sarcoma, preoperative hypofractionated radiation therapy (30 Gy in 5 fractions) followed by immediate surgical resection resulted in no local failures and a median time of 20 days from biopsy to treatment completion.
Wound healing complications occurred in 31% of patients, with only 19% requiring additional surgery, indicating that this treatment approach has a favorable safety profile in terms of wound healing.
Early Outcomes of Preoperative 5-Fraction Radiation Therapy for Soft Tissue Sarcoma Followed by Immediate Surgical Resection.Parsai, S., Lawrenz, J., Kilpatrick, S., et al.[2022]
In a phase II study involving 32 patients with soft tissue sarcomas, a 5-fraction hypofractionated preoperative radiation therapy regimen resulted in no local recurrences and a 3-year overall survival rate of 82.2%.
While the treatment showed excellent local control and survival outcomes, 25% of patients experienced major acute postoperative wound complications, indicating a need for careful monitoring of toxicity.
Is 5 the New 25? Long-Term Oncologic Outcomes From a Phase II, Prospective, 5-Fraction Preoperative Radiation Therapy Trial in Patients With Localized Soft Tissue Sarcoma.Bedi, M., Singh, R., Charlson, JA., et al.[2022]
Neoadjuvant ultra-hypofractionation radiotherapy for soft tissue sarcoma shows a low wound complication rate of 30%, indicating it is a safe treatment option.
The treatment also demonstrates high efficacy with an 87% R0 resection rate and a 96% local control rate over two years, suggesting it effectively prepares patients for surgery.
Preoperative ultra-hypofractionation radiotherapy in extremity/trunk wall soft tissue sarcoma - A meta-analysis of prospective studies.Kao, YS.[2023]

Citations

Early Outcomes of Preoperative 5-Fraction Radiation Therapy for Soft Tissue Sarcoma Followed by Immediate Surgical Resection. [2022]
Is 5 the New 25? Long-Term Oncologic Outcomes From a Phase II, Prospective, 5-Fraction Preoperative Radiation Therapy Trial in Patients With Localized Soft Tissue Sarcoma. [2022]
Preoperative ultra-hypofractionation radiotherapy in extremity/trunk wall soft tissue sarcoma - A meta-analysis of prospective studies. [2023]
Preoperative hypofractionated radiotherapy for soft tissue sarcomas: a systematic review. [2022]
Evaluating Thresholds to Adopt Hypofractionated Preoperative Radiotherapy as Standard of Care in Sarcoma. [2022]
Hypofractionated, 3-week, preoperative radiotherapy for patients with soft tissue sarcomas (HYPORT-STS): a single-centre, open-label, single-arm, phase 2 trial. [2023]
Preoperative hypofractionated radiotherapy in the treatment of localized soft tissue sarcomas. [2018]
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