Recurrent Adult Soft Tissue SarcomaNCT02701153
Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort
A study testing Conventional Surgery, Hypofractionated Radiation Therapy and Laboratory Biomarker Analysis in people with Recurrent Adult Soft Tissue Sarcoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Adult Soft Tissue Sarcoma
- What is being tested?
- Conventional Surgery, Hypofractionated Radiation Therapy and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2016to 3 Feb 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active treatment of a separate malignancy
- History of prior irradiation to the area to be treated
- Pre-operative chemotherapy (post-op acceptable)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Vincent Basehart, 310-267-8954, vbasehart@mednet.ucla.edu
Anusa Kalbasi, M.D.
About this study
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.
Read the detailed description
PRIMARY OBJCETIVES:
- Grade >= 2 radiation morbidity (subcutaneous tissue fibrosis, joint stiffness, or edema) at 2 years.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Recurrent Adult Soft Tissue Sarcoma
- Being tested
- Conventional Surgery, Hypofractionated Radiation Therapy, Laboratory Biomarker Analysis, Questionnaire Administration
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional SurgeryProcedure or surgery
Undergo surgery
Hypofractionated Radiation TherapyRadiation
Also called Hypofractionated Radiotherapy, hypofractionation
Undergo hypofractionated radiation therapy
Laboratory Biomarker AnalysisOther
Correlative studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Conventional Surgery; Radiation: Hypofractionated Radiation Therapy; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (5)
Distant metastasis
Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.
Measured: Up to 3 years
Local failure
Cumulative incidence approach (Kaplan-Meier [K-M] plots and Cox proportional hazard modeling) will be used.
Measured: Up to 3 years
Overall survival
Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.
Measured: Up to 3 years
Progression free survival
Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.
Measured: Up to 3 years
Regional failure
Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study start3 Feb 2016
- Primary completion3 Feb 2027 (estimated)
- Study completion3 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Adult Soft Tissue SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Radiological Society of North America, Sarcoma Alliance for Research through Collaboration, Sarcoma Foundation of America, Tower Cancer Research Foundation
- Responsible party
- Sponsor
- Investigators
- Anusa Kalbasi, MD, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701153
- Sponsor's protocol ID
- 15-001657
- Other IDs
- NCI-2016-00202, 15-001657
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2016
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 41405883