Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06087861

Phase 2 Study of 5-Day Preoperative External Beam Radiation for Soft Tissue Sarcoma

Led by Stanford University · Updated on 2026-04-13

75

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a shorter course of preoperative radiation therapy for patients with soft tissue sarcoma located in the extremity, trunk, or retroperitoneum. This study aims to examine the safety and effectiveness of delivering radiation over five days, compared to the standard treatment which is spread over 25 days. The trial is a Phase 2 study sponsored by Stanford University focused on improving treatment convenience while monitoring outcomes. Participants receive external beam radiotherapy with a total dose of 30 Gy divided into five daily treatments, each delivering 6 Gy. This abbreviated radiation schedule is given prior to surgery, following the standard care plan of preoperative radiation and surgical resection. The study does not include a comparison group and is not blinded. During the trial, participants are monitored for complications occurring up to 120 days after surgery to assess safety. Researchers also track the rate of local cancer recurrence at 2 and 5 years post-surgery. Patients will undergo regular assessments related to treatment response and side effects to evaluate outcomes. Participation duration includes radiation treatment, surgery, and long-term follow-up for cancer control.

CONDITIONS

Brief Title

5-Day Preoperative Radiation for Soft Tissue Sarcoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed soft tissue sarcoma of the extremity, trunk, or retroperitoneum
  • Offered preoperative radiation and surgery as part of standard care
  • Age 18 years or older
  • Karnofsky Performance Status (KPS) 70 or higher, or ECOG 0 to 2
  • Life expectancy of at least 6 months
  • Negative pregnancy test if woman of childbearing potential
  • Ability to understand and willing to sign informed consent
Not Eligible

You will not qualify if you...

  • Previous radiation to the area to be treated
  • Current use of other anti-cancer investigational drugs
  • Planned concurrent chemotherapy, targeted therapy, or immunotherapy with radiation and surgery
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 5 to 10 business days

Participants receive external beam radiotherapy to the tumor and areas of possible microscopic disease with a total dose of 30 Gy delivered over five daily fractions.

5 daily visits (in-person)

Surgery and Immediate Post-operative Care

Duration - Duration of surgery and immediate recovery period

Participants undergo surgical resection following completion of preoperative radiation.

1 visit (in-person) for surgery plus additional post-operative visits as needed

Post-operative Follow-up

Duration - Up to 5 years

Participants are monitored for post-operative complications and local recurrence following surgery.

Visits at 120 days, 2 years, and 5 years after surgery

Trial Site Locations

Total: 1 location

1

Stanford University

Palo Alto, California, United States, 94305

Actively Recruiting

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Research Team

A

Alyssa Yauger

C

Camellia Djebroun

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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