NCT02701153 · Jonsson Comprehensive Cancer Center
Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Conventional Surgery
Undergo surgery
RADIATION
Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
OTHER
Laboratory Biomarker Analysis
Correlative studies
OTHER
Questionnaire Administration
Ancillary studies
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Los Angeles, California
Collaborators
Radiological Society of North America, Sarcoma Alliance for Research through Collaboration, Sarcoma Foundation of America, Tower Cancer Research Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 10, 2026 · Source of record for eligibility and locations