Recruiting
Phase 2

Preoperative Radiation

Sponsor:

Stanford University

Code:

NCT06087861

Conditions

Soft Tissue Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

External Beam Radiotherapy

Study Details

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.

Conditions

Soft Tissue Sarcoma

Study ID

NCT06087861

Start date

Oct 6, 2023

Status verified date

Jun, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: External beam radiotherapy

Patients will receive treatment with external beam radiotherapy at a total of 30 Gy delivered over five fractions delivered daily.

Interventions

External 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

Primary outcome measure

  • Post-operative Complication Rate [ Time Frame: 120 days after surgery ]

Central Contacts and Locations

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94305

Contacts

Principal Investigator:

Anusha Kalbasi, M.D.

More Information

Sponsor

Stanford University

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-06-10.