30 Participants Needed

Hypofractionated vs Conventional Radiation Therapy for Soft Tissue Sarcoma

CC
Overseen ByCancer Connect
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This research study is designed to find out if radiation therapy treatment prior to surgery is safe and effective to treat soft tissue sarcomas. 30 participants with soft tissue sarcoma will be enrolled and can expect to be on study for up to 5 years.

Do I need to stop my current medications for this trial?

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.

What data supports the effectiveness of hypofractionated vs conventional radiation therapy for soft tissue sarcoma?

Research shows that hypofractionated radiation therapy, which uses fewer but higher doses of radiation, can be effective for treating soft tissue sarcoma, especially in situations where shorter treatment times are needed, such as during the COVID pandemic or for elderly patients. Studies have reported positive outcomes with this approach, suggesting it may be a viable alternative to conventional radiation therapy.12345

Is hypofractionated radiation therapy safe for soft tissue sarcoma patients?

Research suggests that hypofractionated radiation therapy, which involves fewer but higher doses of radiation, is generally safe for soft tissue sarcoma patients. Studies indicate that it does not increase toxicity rates compared to conventional methods and may even improve treatment adherence and cost-effectiveness.13467

How does hypofractionated radiation therapy differ from conventional treatment for soft tissue sarcoma?

Hypofractionated radiation therapy for soft tissue sarcoma involves delivering higher doses of radiation in fewer sessions compared to the conventional approach, which typically requires daily treatments over several weeks. This method can shorten the overall treatment time, making it more feasible for patients who may have difficulty with prolonged treatment schedules, such as the elderly or those with limited access to healthcare facilities.12345

Research Team

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Zachary Morris, MD, PhD

Principal Investigator

UW School of Medicine and Public Health

Eligibility Criteria

This trial is for adults over 18 with soft tissue sarcoma who haven't had previous treatments, are fit for surgery, and have good organ function. They must be able to undergo radiation therapy planning and sign consent. Pregnant individuals or those unable to undergo necessary imaging are excluded.

Inclusion Criteria

My blood and kidney tests meet the required levels.
I have a confirmed soft tissue sarcoma in my limb, trunk, or head/neck.
My doctor agrees that specific targeted radiation therapy is safe and suitable for me before surgery.
See 6 more

Exclusion Criteria

I cannot have scans or stay still for radiotherapy planning.
Pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive either conventionally fractionated radiotherapy over 25 treatments in 5 weeks or hypofractionated radiotherapy over 5 treatments in 1-2 weeks

1-7 weeks
Daily visits for radiation treatment

Surgery

Surgical resection of the tumor is performed within 5-14 days after completion of radiotherapy

2 weeks

Follow-up

Participants are monitored for safety, effectiveness, and late toxicity after treatment

up to 5 years
Regular follow-up visits

Treatment Details

Interventions

  • Conventional Fractionated
  • Hypofractionated
Trial OverviewThe study compares two types of pre-surgery radiation therapies: conventional fractionated (standard approach) versus hypofractionated (fewer, higher-dose treatments). It aims to determine the safety and effectiveness of these methods in treating soft tissue sarcomas.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: HypofractionatedExperimental Treatment1 Intervention
the maximum frequency of treatment will be every day and the minimum frequency will be every other day, delivered over a maximum of 3 weeks from the first treatment, surgery will be within 5-14 days of completion of RT
Group II: Conventional FractionatedActive Control1 Intervention
radiation treatments will be delivered daily, delivered over a maximum of 7 weeks from the first treatment, surgery will be within 5-14 days of completion of RT

Conventional Fractionated is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

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Approved in European Union as Conventional Fractionation for:
  • Soft tissue sarcomas
  • Breast cancer
  • Lung cancer
  • Prostate cancer
  • Head and neck cancers
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Approved in United States as Conventional Fractionation for:
  • Soft tissue sarcomas
  • Breast cancer
  • Lung cancer
  • Prostate cancer
  • Head and neck cancers
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Approved in Canada as Conventional Fractionation for:
  • Soft tissue sarcomas
  • Breast cancer
  • Lung cancer
  • Prostate cancer
  • Head and neck cancers
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Approved in Japan as Conventional Fractionation for:
  • Soft tissue sarcomas
  • Breast cancer
  • Lung cancer
  • Prostate cancer
  • Head and neck cancers
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Approved in China as Conventional Fractionation for:
  • Soft tissue sarcomas
  • Breast cancer
  • Lung cancer
  • Prostate cancer
  • Head and neck cancers
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Approved in Switzerland as Conventional Fractionation for:
  • Soft tissue sarcomas
  • Breast cancer
  • Lung cancer
  • Prostate cancer
  • Head and neck cancers

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

Findings from Research

In a study of 272 patients with soft tissue sarcomas, hypofractionated preoperative radiotherapy (5 Gy per fraction) demonstrated similar local control rates (81%) compared to conventional radiotherapy, suggesting it is an effective treatment option.
The treatment was associated with manageable early toxicity, with 42% of patients experiencing some form of treatment-related side effects, and only 7% requiring surgical intervention for complications, indicating a favorable safety profile.
Preoperative hypofractionated radiotherapy in the treatment of localized soft tissue sarcomas.KoseΕ‚a-Paterczyk, H., Szacht, M., MorysiΕ„ski, T., et al.[2018]
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]
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]

References

Preoperative hypofractionated radiotherapy in the treatment of localized soft tissue sarcomas. [2018]
Preoperative ultra-hypofractionation radiotherapy in extremity/trunk wall soft tissue sarcoma - A meta-analysis of prospective studies. [2023]
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]
Early Outcomes of Preoperative 5-Fraction Radiation Therapy for Soft Tissue Sarcoma Followed by Immediate Surgical Resection. [2022]
Hypofractionated preoperative radiotherapy for high risk soft tissue sarcomas in a geriatric patient population. [2022]
Preoperative hypofractionated radiotherapy for soft tissue sarcomas: a systematic review. [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]