5-Day Preoperative Radiation for Soft Tissue Sarcoma

Sponsor: Stanford University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06087861

Patient View

This clinical trial evaluates a 5-day preoperative radiation regimen for soft tissue sarcoma, contrasting the standard 25-day course. Eligible participants are adults with confirmed sarcoma, a KPS ≥ 70 or ECOG 0-2, and a life expectancy of ≥ 6 months. The intervention involves delivering 30 Gy via external beam radiotherapy in 5 fractions. Participants must consent and, if applicable, test negative for pregnancy.

Patient Parameters

Program Overview

The purpose of this study is to examine the safety and efficacy of an abbreviated course of preoperative radiation, given over five days, for patients with soft tissue sarcoma of the extremity, trunk or retroperitoneum. This is in contrast to standard preoperative radiation, which is given over 25 days.

Eligibility Criteria

Inclusion Criteria

  1. Histologically confirmed soft tissue sarcoma of the extremity, trunk or retroperitoneum.
  2. Has been offered preoperative radiation and surgery as part of standard-of-care treatment
  3. Age ≥ 18
  4. KPS ≥ 70 or ECOG 0 to 2
  5. Life expectancy ≥ 6 months
  6. If a woman is of childbearing potential, a negative serum or urine pregnancy test must be documented.
  7. Ability to understand and the willingness to personally sign the written IRB approved informed consent document.

Exclusion Criteria

  1. History of prior radiation to the area to be treated.
  2. Active use of other anti-cancer investigational agents.
  3. Planned use of concurrent chemotherapy, targeted therapy, or immunotherapy with radiation therapy (defined as the time interval starting 1 week before the first and last fraction of radiation therapy and surgery).
  4. Pregnancy.

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