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

Conditions

Recurrent Adult Soft Tissue Sarcoma

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.

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.

Jie Deng, Aastha Pal, Stefano Testa, Jingyu W. Xu, Linh M. Tran et al. (37 authors)

2026-07-01

10.1158/2159-8290.32845852

Five-Day Preoperative Radiation Therapy for Patients With High-Risk Soft Tissue Sarcoma: A Nonrandomized Clinical Trial.

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.

2025-12-01

10.1001/jamanetworkopen.2025.50195

MicroRNA-based biomarkers of outcome in soft tissue sarcoma treated with hypofractionated preoperative radiation therapy.

Joanne B. Weidhaas, Kristen M. McGreevy, John Nikitas, Anusha Kalbasi, Vishruth K. Reddy et al. (6 authors)

Journal of Clinical Oncology2025-05-28

10.1200/jco.2025.43.16_suppl.11538

Interventions

PROCEDUREConventional Surgery

Undergo surgery

RADIATIONHypofractionated Radiation Therapy

Undergo hypofractionated radiation therapy

OTHERLaboratory Biomarker Analysis

Correlative studies

OTHERQuestionnaire Administration

Ancillary studies

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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)

Design outcomes

Primary

Measure	Time frame	Description
Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema)	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.

Secondary

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

Countries

United States

Contacts

CONTACTJackie Hernandez

jhernandez@mednet.ucla.edu310-206-8477

PRINCIPAL_INVESTIGATORAnusa Kalbasi, MD

UCLA / Jonsson Comprehensive Cancer Center

Outcome results

None listed