5-Day Preoperative Radiation for Soft Tissue Sarcoma
Phase 2 5-Day Preoperative Radiation for Soft Tissue Sarcoma
2 other identifiers
interventional
75
1 country
1
Brief Summary
The purpose of this study is to examine the safety and efficacy of an abbreviated course of preoperative radiation, given over five days, for patients with soft tissue sarcoma of the extremity, trunk or retroperitoneum. This is in contrast to standard preoperative radiation, which is given over 25 days.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 6, 2023
CompletedFirst Submitted
Initial submission to the registry
October 11, 2023
CompletedFirst Posted
Study publicly available on registry
October 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
April 13, 2026
April 1, 2026
2.7 years
October 11, 2023
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Post-operative Complication Rate
Rate of post-operative complications.
120 days after surgery
Secondary Outcomes (1)
Local Recurrence Rate
2 years and 5 years after surgical resection
Study Arms (1)
External beam radiotherapy
EXPERIMENTALPatients will receive treatment with external beam radiotherapy at a total of 30 Gy delivered over five fractions delivered daily.
Interventions
Radiation will be delivered by external beam techniques to the tumor and areas of possible microscopic disease at a dose of 30 Gy divided into 5 equal fractions of 6 Gy (administered over a total of 5 to 10 business day
Eligibility Criteria
You may qualify if:
- Histologically confirmed soft tissue sarcoma of the extremity, trunk or retroperitoneum.
- Has been offered preoperative radiation and surgery as part of standard-of-care treatment
- Age ≥ 18
- KPS ≥ 70 or ECOG 0 to 2
- Life expectancy ≥ 6 months
- If a woman is of childbearing potential, a negative serum or urine pregnancy test must be documented.
- Ability to understand and the willingness to personally sign the written IRB approved informed consent document.
You may not qualify if:
- History of prior radiation to the area to be treated.
- Active use of other anti-cancer investigational agents.
- Planned use of concurrent chemotherapy, targeted therapy, or immunotherapy with radiation therapy (defined as the time interval starting 1 week before the first and last fraction of radiation therapy and surgery).
- Pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University
Palo Alto, California, 94305, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anusha Kalbasi, MD
Stanford University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2023
First Posted
October 18, 2023
Study Start
October 6, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
April 13, 2026
Record last verified: 2026-04