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

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: Recurrent Adult Soft Tissue Sarcoma
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Procedure: Conventional Surgery; Radiation: Hypofractionated Radiation Therapy

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

• Study Contact: Name: Jackie Hernandez; Phone Number: 97624 310-206-8477; Email: jhernandez@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA / Jonsson Comprehensive Cancer Center
      • Principal Investigator: Anusa Kalbasi, M.D.
      • Contact: Vincent Basehart; Phone Number: 310-267-8954; Email: vbasehart@mednet.ucla.edu

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2016
• Primary Completion (Estimated): February 3, 2025
• Study Completion (Estimated): February 3, 2026

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 (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma
• Other Study ID Numbers: 15-001657 (Other Identifier: UCLA / Jonsson Comprehensive Cancer Center); NCI-2016-00202 (Registry Identifier: CTRP (Clinical Trial Reporting Program))