5-Day Preoperative Radiation for Soft Tissue Sarcoma

• Sponsor: Stanford University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06087861
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 26.9
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Soft Tissue Sarcoma	Radiation: External Beam Radiotherapy	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 75 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 2 5-Day Preoperative Radiation for Soft Tissue Sarcoma
• Actual Study Start Date: Oct 6, 2023
• Anticipated Primary Completion Date: Jan 1, 2026
• Anticipated Study Completion Date: Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: External beam radiotherapy Patients will receive treatment with external beam radiotherapy at a total of 30 Gy delivered over five fractions delivered daily.	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

Outcome Measures

Primary Outcome Measures

1. Post-operative Complication Rate [120 days after surgery]

   Rate of post-operative complications.

Secondary Outcome Measures

1. Local Recurrence Rate [2 years and 5 years after surgical resection]

   Rate of local recurrence, including in-field, borderline and out-field recurrences

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Anusha Kalbasi, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT06087861
• Other Study ID Numbers: IRB-71865; Sarcoma0064
• First Posted: Oct 18, 2023
• Last Update Posted: Oct 18, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sarcoma

Study Results

No Results Posted as of Oct 18, 2023