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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00202 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 15-001657 | Other Identifier | UCLA / Jonsson Comprehensive Cancer Center |
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| Name | Class |
|---|---|
| Radiological Society of North America | OTHER |
| Sarcoma Alliance for Research through Collaboration | OTHER |
| Sarcoma Foundation of America | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Surgery | Procedure | Undergo surgery |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jackie Hernandez | Contact | 310-206-8477 | 97624 | jhernandez@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anusa Kalbasi, MD | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41405883 | Derived | 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. |
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| Tower Cancer Research Foundation |
| UNKNOWN |
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| Hypofractionated Radiation Therapy |
| Radiation |
Undergo hypofractionated radiation therapy |
|
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| 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 |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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