Recruiting

Hypofractionated Radiation Therapy

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT02701153

Conditions

Recurrent Adult Soft Tissue Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Conventional Surgery

Hypofractionated Radiation Therapy

Laboratory Biomarker Analysis

Questionnaire Administration

Study Details

Brief summary:

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.

Conditions

Recurrent Adult Soft Tissue Sarcoma

Study ID

NCT02701153

Start date

Feb 3, 2016

Status verified date

Mar, 2026

Completion date

Feb 3, 2028

Anticipated

Primary completion date

Feb 3, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

51 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Conventional Surgery

Undergo surgery

Hypofractionated Radiation Therapy

Undergo hypofractionated radiation therapy

Laboratory Biomarker Analysis

Correlative studies

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema) [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Jackie Hernandez

310-206-8477jhernandez@mednet.ucla.edu

Locations

UCLA / Jonsson Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Vincent Basehart

310-267-8954vbasehart@mednet.ucla.edu

Principal Investigator:

Anusa Kalbasi, M.D.

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Mar 10, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2026-03-10.