Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort

March 6, 2026 updated by: Jonsson Comprehensive Cancer Center
This phase II trial studies the side effects of hypofractionated radiation therapy in treating patients with soft tissue sarcomas prior to surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJCETIVES:

I. Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema) at 2 years.

SECONDARY OBJECTIVES:

I. Evaluate local control, regional control, distant metastasis, progression free survival, and overall survival.

II. Evaluate the functional outcomes as assessed using the musculoskeletal tumor rating scale (MSTS) and the Toronto Extremity Salvage Score (TESS).

III. Collect germ-line deoxyribonucleic acid (DNA) and nucleic acids from cancer patients to further investigate the association and identify new germ-line mutations that impact cancer predisposition.

IV. Investigate the role of germ-line mutations in predicting cancer outcome and response to therapy.

OUTLINE:

Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.

After completion of study treatment, patients are followed up at 3 months and then every 6 months for 5 years.

Study Type

Interventional

Enrollment (Estimated)

51

Phase

  • Not Applicable

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 Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA / Jonsson Comprehensive Cancer Center
        • Principal Investigator:
          • Anusa Kalbasi, M.D.
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed soft tissue sarcoma of the extremity/trunk
  • Intermediate or high grade sarcoma
  • Resectable primary lesion (patients with pre-existing metastasis will be included if their primary is still going to be resected)
  • Recurrent, any grade, no previous radiation therapy
  • Karnofsky performance status (KPS) >= 70 or Eastern Cooperative Oncology Group (ECOG) 0 - 2
  • If a woman is of childbearing potential, a negative serum pregnancy test must be documented

Exclusion Criteria:

  • Active treatment of a separate malignancy
  • History of prior irradiation to the area to be treated
  • Pre-operative chemotherapy (post-op acceptable)

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: Treatment (hypofractionated radiation therapy)
Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Questionnaire Administration
Ancillary studies
Procedure: Conventional Surgery
Undergo surgery
Radiation: Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Other Names:
  • Hypofractionated Radiotherapy
  • hypofractionation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema)
Time Frame: Up to 2 years
Interim reports will be prepared every six months until the results of the study are published. In general, the interim reports will contain information about patient accrual rate with projected completion dates, status of question-answer (QA) review and compliance rate of treatment per protocol, and the frequencies and severity of toxicity.
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distant metastasis
Time Frame: Up to 3 years
Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.
Up to 3 years
Local failure
Time Frame: Up to 3 years
Cumulative incidence approach (Kaplan-Meier [K-M] plots and Cox proportional hazard modeling) will be used.
Up to 3 years
Overall survival
Time Frame: Up to 3 years
Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.
Up to 3 years
Progression free survival
Time Frame: Up to 3 years
Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.
Up to 3 years
Regional failure
Time Frame: Up to 3 years
Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.
Up to 3 years

Collaborators and Investigators

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

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

Sarcoma Alliance for Research through Collaboration
Radiological Society of North America
Tower Cancer Research Foundation
Sarcoma Foundation of America

Investigators

  • Principal Investigator: Anusa Kalbasi, MD, UCLA / Jonsson Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 3, 2016

Primary Completion (Estimated)

February 3, 2027

Study Completion (Estimated)

February 3, 2028

Study Registration Dates

First Submitted

March 2, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (Estimated)

March 8, 2016

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-001657 (Other Identifier: UCLA / Jonsson Comprehensive Cancer Center)
  • NCI-2016-00202 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

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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