Hypofractionated Radiotherapy for Soft Tissue Sarcomas

This study is looking at a new way to treat soft tissue sarcomas (cancers that form in the soft tissues of the body, like muscle, fat, or nerves). It tests two different schedules of pre-operative radiation, called Ultra-Hypo-fractionation Radiotherapy (5 days of radiation) or Moderately-Hypo-fractionation Radiotherapy (15 days of radiation), followed by surgery (Resection). This approach aims to shorten the radiation treatment time compared to the usual 5-week course, without increasing problems with wound healing or the cancer coming back. The main goal is to see how well the cancer is controlled locally (Local control rate) after about 2 years. You might be able to join if you have a soft tissue sarcoma in an arm, leg, pelvis, chest wall, or trunk/abdominal wall, are at least 18 years old, and are healthy enough for radiation and surgery. The study is currently unclear on its recruitment status.

Study design
This is an interventional study where patients are assigned to one of two groups for radiation treatment before surgery. It plans to enroll 40 participants.
What's involved
You would receive either 5 or 15 daily radiation treatments, followed by surgery. You would also complete questionnaires for ancillary studies.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you would have follow-up visits within 3 months, then every 3-6 months for at least 2 years.

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NCT04506008

Hypofractionated Radiotherapy Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas

Recruiting
PHASE2Ages 18+InterventionalTreatment
Vanderbilt-Ingram Cancer Center
~40 participants
Updated 2025-03-28 on ClinicalTrials.gov
What's tested:Ultra-Hypo-fractionation RadiotherapyResectionQuestionnaire AdministrationModerately-Hypo-fractionation Radiotherapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Local control rate
Measured over Approximately 2 years
Soft Tissue Sarcomas
1 sites across 1 states
Tennessee1
  • Eric Shinohara, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt Medical Center
Vanderbilt-Ingram Service for Timely Access
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Eligibility criteria

Inclusion

Histologic diagnosis of a soft tissue sarcoma of extremity, pelvis, chest wall or trunk/abdominal wall (non-retroperitoneal location)
ECOG performance status 0-2
Patient must be deemed able to comply with radiation treatment and surgery

Exclusion

History of prior radiation to the same area to be irradiated
Pregnancy
Active collagen vascular disease or patients genetically predisposed to increased radiation related side effects
  • Local control rateApproximately 2 years

    Will be estimated with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution. The median and a 95% credible interval of the posterior distribution will be reported.