5-Day Preoperative Radiation for Soft Tissue Sarcoma

Phase 2

Recruiting

• Conditions: Soft Tissue Sarcoma
• Interventions: Radiation: External Beam Radiotherapy

• Registration Number: NCT06087861
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-06
• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-10-11
• Study First Posted: 2023-10-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-14
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
External beam radiotherapy	External Beam Radiotherapy	Patients will receive treatment with external beam radiotherapy at a total of 30 Gy delivered over five fractions delivered daily.

Primary Outcome Measures

Name	Time	Method
Post-operative Complication Rate	120 days after surgery	Rate of post-operative complications.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States