5-Day Preoperative Radiation for Soft Tissue Sarcoma

June 8, 2026 updated by: Stanford University

Phase 2 5-Day Preoperative Radiation for Soft Tissue Sarcoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Recruiting
        • Stanford University
        • Principal Investigator:
          • Anusha Kalbasi, M.D.
        • Sub-Investigator:
          • Everett Moding
        • Sub-Investigator:
          • Susie Hiniker
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: External beam radiotherapy
Patients will receive treatment with external beam radiotherapy at a total of 30 Gy delivered over five fractions delivered daily.
Radiation: External Beam Radiotherapy
Radiation will be delivered by external beam techniques to the tumor and areas of possible microscopic disease at a dose of 30 Gy divided into 5 equal fractions of 6 Gy (administered over a total of 5 to 10 business day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Complication Rate
Time Frame: 120 days after surgery
Rate of post-operative complications.
120 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Recurrence Rate
Time Frame: 2 years and 5 years after surgical resection
Rate of local recurrence, including in-field, borderline and out-field recurrences
2 years and 5 years after surgical resection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Anusha Kalbasi, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

October 11, 2023

First Submitted That Met QC Criteria

October 11, 2023

First Posted (Actual)

October 18, 2023

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-71865
  • NCI-2024-00868 (Registry Identifier: NCI- Clinical Trials Reporting Program)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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