5-Day Preoperative Radiation for Soft Tissue Sarcoma

Soft Tissue Sarcoma Clinical Trial

Official title:

Phase 2 5-Day Preoperative Radiation for Soft Tissue Sarcoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06087861
• Other study ID #: IRB-71865
• Secondary ID: Sarcoma0064
• Status: Recruiting
• Phase: Phase 2
• Start date: October 6, 2023
• Est. completion date: January 2026

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: Jillian Skerchak
• Phone: 650-721-4072
• Email: jskerch1[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Radiation:
• 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

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative Complication Rate	Rate of post-operative complications.	120 days after surgery
Secondary	Local Recurrence Rate	Rate of local recurrence, including in-field, borderline and out-field recurrences	2 years and 5 years after surgical resection