Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort
NCT ID: NCT02701153
Last Updated: 2025-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
51 participants
INTERVENTIONAL
2016-02-03
2027-02-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma
NCT06905132
Hypofractionated Radiotherapy for Soft Tissue Sarcomas
NCT03972930
Hypofractionated vs Conventional Fractionated RT in Soft Tissue Sarcomas
NCT05109494
5-Day Preoperative Radiation for Soft Tissue Sarcoma
NCT06087861
Feasibility Trial of Preoperative 5-Day Hypofractionated Radiotherapy for Primary Soft Tissue Sarcoma
NCT05776667
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment (hypofractionated radiation therapy)
Patients undergo hypofractionated radiation therapy on Monday-Friday for 5 days. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.
Conventional Surgery
Undergo surgery
Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Laboratory Biomarker Analysis
Correlative studies
Questionnaire Administration
Ancillary studies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Conventional Surgery
Undergo surgery
Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Laboratory Biomarker Analysis
Correlative studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* History of prior irradiation to the area to be treated
* Pre-operative chemotherapy (post-op acceptable)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Radiological Society of North America
OTHER
Sarcoma Alliance for Research through Collaboration
OTHER
Sarcoma Foundation of America
UNKNOWN
Tower Cancer Research Foundation
UNKNOWN
Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anusa Kalbasi, MD
Role: PRINCIPAL_INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2016-00202
Identifier Type: REGISTRY
Identifier Source: secondary_id
15-001657
Identifier Type: OTHER
Identifier Source: secondary_id
15-001657
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.