Study Comparing Two Types of Radiation Therapy for Soft Tissue Sarcomas

Sponsor: University of Wisconsin, Madison

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05109494

This clinical trial is exploring whether a shorter, more intense form of radiation therapy before surgery is as safe and effective as the traditional longer treatment for patients with soft tissue sarcomas.

Patient Parameters

Program Overview

The study aims to determine if a new method of delivering radiation therapy, called hypofractionated radiotherapy, is safe and effective for treating soft tissue sarcomas before surgery. This method uses higher doses of radiation over fewer sessions compared to the traditional approach, which spreads out smaller doses over several weeks. The trial will involve 30 participants and will last up to 5 years.

Description

Soft tissue sarcomas are typically treated with a combination of radiation therapy and surgery. Traditionally, radiation is given in smaller doses over about 5 weeks before surgery. This is known as conventionally fractionated radiotherapy. In this study, researchers are testing a different approach called hypofractionated radiotherapy, which involves giving higher doses of radiation over a shorter period, usually 1-2 weeks.

The goal is to see if this shorter treatment is just as effective at shrinking tumors and preparing them for surgery, while also reducing side effects and the time between diagnosis and surgery. Participants will be divided into two groups: one receiving the traditional 5-week treatment and the other receiving the shorter 1-2 week treatment.

The study will evaluate how well the tumors respond to each type of radiation therapy, any complications with wound healing, and the long-term effects of the treatments. Researchers will also look at how well the cancer is controlled and how long patients remain free of disease after treatment. Additionally, they will study the quality of life of patients undergoing each type of therapy.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with soft tissue sarcoma in the limbs, trunk, or head and neck.
  • No previous treatment specifically for sarcoma.
  • Aged 18 years or older.
  • Able to perform daily activities with some assistance (Karnofsky score of 60 or higher).
  • Capable of understanding and signing a consent form.
  • Expected to live for more than 12 weeks.
  • Both types of radiation therapy (hypofractionated and conventional) are considered safe and possible by the doctor.
  • Tumor can be surgically removed, and the patient is fit for surgery within 5-14 days after radiation.
  • Sufficient blood cell counts and kidney function as determined by specific medical tests.

Exclusion Criteria

  • Pregnant women.
  • Unable to undergo necessary imaging or positioning for planning radiation therapy.

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