NCT02701153

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
21mo left

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Feb 2016Feb 2028

Study Start

First participant enrolled

February 3, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2028

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

11 years

First QC Date

March 2, 2016

Last Update Submit

March 6, 2026

Conditions

Recurrent Adult Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

  • Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema)

    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 Outcomes (5)

  • Distant metastasis

    Up to 3 years

  • Local failure

    Up to 3 years

  • Overall survival

    Up to 3 years

  • Progression free survival

    Up to 3 years

  • Regional failure

    Up to 3 years

Study Arms (1)

Treatment (hypofractionated radiation therapy)

EXPERIMENTAL

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

Procedure: Conventional SurgeryRadiation: Hypofractionated Radiation TherapyOther: Laboratory Biomarker AnalysisOther: Questionnaire Administration

Interventions

Conventional SurgeryPROCEDURE

Undergo surgery

Treatment (hypofractionated radiation therapy)
Hypofractionated Radiation TherapyRADIATION

Undergo hypofractionated radiation therapy

Also known as: Hypofractionated Radiotherapy, hypofractionation
Treatment (hypofractionated radiation therapy)
Laboratory Biomarker AnalysisOTHER

Correlative studies

Treatment (hypofractionated radiation therapy)
Questionnaire AdministrationOTHER

Ancillary studies

Treatment (hypofractionated radiation therapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

Related Publications (1)

  • Nikitas J, Kendal JK, Savjani RR, Jackson N, Peterson N, Deng J, Hernandez J, Chong N, Singh AS, Chmielowski B, Federman NC, Crompton JG, Kadera BE, Wessel LE, Christ AB, Nelson SD, Dry SM, Weidhaas JB, Steinberg ML, Bernthal NM, Eilber FC, Kalbasi A, Reddy VK. Five-Day Preoperative Radiation Therapy for Patients With High-Risk Soft Tissue Sarcoma: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2550195. doi: 10.1001/jamanetworkopen.2025.50195.

    PMID: 41405883DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Dose Fractionation, RadiationRadiotherapy DosageRadiotherapyTherapeutics

Study Officials

  • Anusa Kalbasi, MD

    UCLA / Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jackie Hernandez

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 8, 2016

Study Start

February 3, 2016

Primary Completion (Estimated)

February 3, 2027

Study Completion (Estimated)

February 3, 2028

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations

US(1)