A Phase 2 interventional study of Hypofractionated Radiation Therapy and Quality-of-Life Assessment in Resectable Soft Tissue Sarcoma, Stage I Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 and Stage IA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, sponsored by M.D. Anderson Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
This phase II trial studies the wound complication risk of shorter course, hypofractionated pre-surgery radiation therapy in treating patients with localized soft tissue sarcoma of the extremity of superficial trunk that can be removed by 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. Shorter course hypofractionated pre surgery radiation therapy may be more convenient for patients with soft tissue sarcoma than a longer course of radiation therapy, and may result in fewer complications.
PRIMARY OBJECTIVES:
I. To determine, in patients with localized, resectable soft tissue sarcoma, whether there is a non-inferior major wound complication rate for patients receiving 42.75 Gy in 15 fractions over 3 weeks compared to historical controls who received 50 Gy in conventional fractionation over 5-6 weeks.
SECONDARY OBJECTIVES:
I. To determine whether local control rates among patients treated with 42.75 Gy in 15 fractions is similar to that observed in previous studies for patients treated with 50 Gy in conventional fractionation over 5-6 weeks.
II. To determine whether patterns of local relapse, relapse free survival, overall survival, or metastatic disease free survival for patients treated with 42.75 Gy in 15 fractions are similar to previously reported studies.
III. To determine where there is a difference in pathologic response in tumor specimens treated with 42.75 Gy in 15 fractions compared to previously reported rates of hyalinization, fibrosis, or necrosis.
IV. To explore quality of life, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G), financial toxicity as measured by the Comprehensive Score for financial Toxicity (COST) Instrument, and patient reported outcomes, as measured by the Toronto Extremity Salvage Score (TESS), among individuals undergoing a shorter, hypofractionated course of pre-operative radiation therapy for soft tissue sarcoma of the extremity or superficial trunk.
V. To gather subjective data on patient treatment preferences and experiences among individuals undergoing a shorter, hypofractionated course of pre-operative radiation therapy for soft tissue sarcoma of the extremity or superficial trunk.
OUTLINE:
Patients receive hypofractionated radiation therapy in 15 daily fractions over 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3-4 months for 2 years, every 6 months for 3 years, and then every year for up to 10 years.
M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive hypofractionated radiation therapy in 15 daily fractions over 3 weeks in the absence of disease progression or unacceptable toxicity.
Radiation: Hypofractionated Radiation Therapy · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Undergo hypofractionated RT
Also known as: Hypofractionated Radiotherapy, Hypofractionated
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
Time to a major wound complication (MWC)
A Bayesian approach for the analysis of a stopping rule of higher acute wound complications for the new dose (E) will be employed.
Time frame: Up to 120 days after surgery
Local recurrence free survival
The data from long-term follow-up will be analyzed for the local recurrence free survival. Kaplan-Meier curves will be generated of survival estimates. We will compare these to historical controls.
Time frame: Up to 10 years after radiation therapy
Disease free survival (DFS) time
The data from long-term follow-up will be analyzed for disease-free survival. Kaplan-Meier curves will be generated of survival estimates. Will compare these to historical controls.
Time frame: Up to 10 years after radiation therapy
Time to relapse
Time frame: Up to 10 years after radiation therapy
Disease specific survival time
Kaplan-Meier curves will be generated of survival estimates.
Time frame: Up to 10 years after radiation therapy
Pattern of local relapse (in radiation field, margin of field, out of radiation field)
Time frame: Up to 10 years after radiation therapy
Incidence of acute toxicity other than MWC
Acute toxicity will be documented and rates tabulated.
Time frame: Up to 120 days after radiation therapy
Incidence of late onset toxicity
Late radiation toxicity will be documented and rates tabulated.
Time frame: Up to 120 days after radiation therapy
Functional outcomes
Limb function and overall patient quality of life/functional status will be documented according to the Musculoskeletal Tumor Society (MSTS) and Toronto Extremity Salvage Score (TESS) and Euroqol-5D (EQ5D), which will be summarized and analyzed as a continuous variable. Differences between mean scores will be tested using the Mann-Whitney test. Mean and median and their 95% confidence interval (CI) will be presented.
Time frame: Up to 10 years after radiation therapy
Quality of life
Limb function and overall patient quality of life/functional status will be documented according to the MSTS and TESS and Euroqol-5D (EQ5D), which will be summarized and analyzed as a continuous variable. Differences between mean scores will be tested using the Mann-Whitney test. Mean and median and their 95% CI will be presented.
Time frame: Up to 10 years after radiation therapy
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center