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RecruitingInterventionalPhase 2

Phase 2 5-Day Preoperative Radiation for Soft Tissue Sarcoma

NCT ID: NCT06087861Sponsor: Stanford UniversityLast updated: 2026-06-10

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.

Arms & interventions

  • RadiationExternal Beam Radiotherapy

    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

Outcome measures

Primary

  • Post-operative Complication Rate

    Rate of post-operative complications.

    Time frame: 120 days after surgery

Secondary

  • Local Recurrence Rate

    Time frame: 2 years and 5 years after surgical resection

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: 1. Histologically confirmed soft tissue sarcoma of the extremity, trunk or retroperitoneum. 2. Has been offered preoperative radiation and surgery as part of standard-of-care treatment 3. Age ≥ 18 4. KPS ≥ 70 or ECOG 0 to 2 5. Life expectancy ≥ 6 months 6. If a woman is of childbearing potential, a negative serum or urine pregnancy test must be documented. 7. Ability to understand and the willingness to personally sign the written IRB approved informed consent document. Exclusion Criteria: 1. History of prior radiation to the area to be treated. 2. Active use of other anti-cancer investigational agents. 3. 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). 4. Pregnancy.

Study locations (1)

Stanford University

Palo Alto, California, 94305

Recruiting
Alyssa Yauger · Contact
Aastha Dubey · Contact
Anusha Kalbasi, M.D. · Principal Investigator
Everett Moding · Sub Investigator
Susie Hiniker · Sub Investigator
5-Day Preoperative Radiation for Soft Tissue Sarcoma | Cancerify