Study on Shortened Radiation Therapy Followed by Surgery for Treating Soft Tissue Sarcomas

Sponsor: Vanderbilt-Ingram Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04506008

Provider View

This clinical trial is testing a shorter course of radiation therapy, followed by surgery, to treat soft tissue sarcomas. The aim is to see if this approach is as effective as the traditional longer radiation treatment, without increasing the risk of complications.

Patient Parameters

Program Overview

The study is exploring a new treatment method for soft tissue sarcomas, which involves giving patients a shorter course of radiation therapy before surgery. This approach, called hypofractionated radiotherapy, reduces the treatment time to either 5 or 15 days, compared to the usual 5-week regimen. Researchers want to find out if this shorter treatment is just as effective in controlling the cancer and does not lead to more wound complications or cancer returning.

Description

The main goals of this study are to see how well a shorter course of radiation therapy works in controlling soft tissue sarcomas and to understand the side effects. Patients will be divided into two groups:

  • Group I (Ultra-Hypofractionation): Patients will receive radiation therapy every day for 5 sessions, followed by surgery.
  • Group II (Moderate Hypofractionation): Patients will receive radiation therapy every day for 15 sessions, followed by surgery.

After finishing the treatment, patients will have follow-up visits within 3 months, and then every 3 to 6 months for at least 2 years to monitor their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with soft tissue sarcoma located in the arms, legs, pelvis, chest wall, or trunk/abdominal wall (not in the retroperitoneal area).
  • In good general health, with an ECOG performance status of 0 to 2, meaning fully active or able to carry out light work.
  • Able to undergo both radiation treatment and surgery.

Exclusion Criteria

  • Have had radiation treatment to the same area before.
  • Are pregnant.
  • Have active collagen vascular disease or a genetic predisposition to increased side effects from radiation.

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