5-Day Preoperative Radiation for Soft Tissue Sarcoma

Stanford University

Status and phase: Enrolling; Phase 2

Conditions: Soft Tissue Sarcoma

Treatments: Radiation: External Beam Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06087861

NCI-2024-00868 (Registry Identifier)

IRB-71865

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

External beam radiotherapy

Experimental group

Description:

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

Treatment:

Radiation: External Beam Radiotherapy