What side effects are associated with this type of intervention?

The most common treatments for Soft Tissue Sarcoma, including hypofractionated radiotherapy and chemotherapy, have several known side effects. Hypofractionated radiotherapy, which delivers a higher biologically effective dose in fewer fractions, can lead to acute gastrointestinal toxicity and a somewhat increased risk of late toxicity. Chemotherapy regimens, particularly those involving doxorubicin and ifosfamide, can cause significant toxicities such as potential sterility, cardiomyopathy, renal damage, second cancers, and overall impairment of quality of life. These side effects must be carefully weighed against the potential benefits when considering treatment options.

What prior FDA approvals exist?

FDA-approved treatments for Soft Tissue Sarcoma (STS) include several chemotherapeutic and targeted agents. Notable drugs include Trabectedin, which is approved for advanced liposarcoma and leiomyosarcoma, and Eribulin, approved for liposarcoma and leiomyosarcoma. Pazopanib is another approved drug for advanced sarcomas excluding liposarcoma and gastrointestinal stromal tumors (GIST). While the context does not provide specific FDA approvals for Hypofractionated Radiotherapy, this approach is being studied for its potential to deliver higher biologically effective doses in fewer fractions, potentially improving treatment outcomes for STS.

What other types of research exist?

Promising novel alternatives to Hypofractionated Radiotherapy for Soft Tissue Sarcoma patients include the use of multitargeted kinase inhibitors such as regorafenib, cabozantinib, sorafenib, and lenvatinib (in combination with etoposide and ifosfamide). These agents have shown limited activity in advanced osteosarcoma and may offer potential benefits for STS patients. Additionally, immune checkpoint inhibitors like pembrolizumab and nivolumab are being explored for their efficacy in various sarcomas, including soft tissue sarcomas.

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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

Must not have

Previous irradiation to the area to be treated

Lesions below the knee

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy on the area that needs treatment now.

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I have lesions below my knee.

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I had an unexpected surgery to remove cancer at another hospital.

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My cancer has spread to nearby lymph nodes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acute RadiationToxicity using Common Terminology Criteria for Adverse Events (CTCAE) V.5

Secondary study objectives

Physicians Muscle Tumor Rating Scale

Side effects data

From 2023 Phase 2 trial • 88 Patients • NCT02783690

89%

Dermatitis radiation

75%

Skin hyperpigmentation

34%

Joint range of motion decreased

25%

Lymphedema

23%

Telangiestasia

23%

Fibrosis deep connective tissue

23%

Edema limbs

18%

Non-cardiac chest pain

11%

Superficial soft tissue fibrosis

11%

Esophagitis

Breast infection

Skin hypopigmentation

100%

80%

60%

40%

20%

Study treatment Arm

Conventional Fractionation

Hypofractionation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~550

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Soft Tissue Sarcoma (STS) include chemotherapy, radiotherapy, and their combinations. Chemotherapy works by using drugs to kill rapidly dividing cancer cells, which can help shrink tumors and make them easier to remove surgically. Radiotherapy uses high-energy radiation to damage the DNA of cancer cells, leading to cell death. Hypofractionated radiotherapy, which delivers a higher biologically effective dose in fewer fractions, aims to maximize tumor control while minimizing treatment time and potentially reducing side effects. This approach is particularly important for STS patients as it can improve the effectiveness of treatment, reduce the delay to surgery, and potentially enhance overall survival rates.

Preoperative radiation therapy for sarcoma of soft tissue.Long-term Outcomes With Ifosfamide-based Hypofractionated Preoperative Chemoradiotherapy for Extremity Soft Tissue Sarcomas.Hypofractionated radiotherapy for prostate cancer.