5-Day Preoperative Radiation for Soft Tissue Sarcoma

Phase 2 5-Day Preoperative Radiation for Soft Tissue Sarcoma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06087861

Enrollment

Registered

2023-10-18

Start date

2023-10-06

Completion date

2029-12-01

Last updated

2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soft Tissue Sarcoma

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.

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Post-operative Complication Rate	120 days after surgery	Rate of post-operative complications.

Secondary

Measure	Time frame	Description
Local Recurrence Rate	2 years and 5 years after surgical resection	Rate of local recurrence, including in-field, borderline and out-field recurrences

Countries

United States

Contacts

CONTACTAlyssa Yauger

ayauger@stanford.edu650-498-5271

CONTACTAastha Dubey

adubey7@stanford.edu650-725-2084

PRINCIPAL_INVESTIGATORAnusha Kalbasi, MD

Stanford University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026