NCT06812052

Short Course Radiation Treatment for Patients With Primary or Locally Recurrent Retroperitoneal Sarcoma Prior to Surgery

Prospective Phase I Trial of Hypofractionated Radiation Therapy in Retroperitoneal Sarcoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the safety of moderately hypofractionated radiation in the treatment of primary and locally recurrent RPS, based on the evaluation of acute radiation-related toxicity profile of each participant (30-day radiation toxicity)

Detailed description

To determine the safety of moderately hypofractionated radiation in the treatment of primary and locally recurrent RPS, based on the evaluation of acute radiation-related toxicity profile of each participant (30-day radiation toxicity)

Conditions

• Retroperitoneal Sarcoma

Interventions

Type	Name	Description
RADIATION	Radiation Therapy	In this study, patients will receive a hypofractionated course of radiation therapy of 2.85 Gy x 15 fractions (42.75 Gy). If there are 2 or more patients with dose-limiting toxicities, the radiation course will be de-escalated to 2.7 Gy x 15 fractions (40.5 Gy).
RADIATION	Hypofractionationed Radiation Therapy	This group is receiving hypofractionated radiation therapy (shorter course of RT)

Timeline

• Start date: 2025-05-29
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2025-02-06
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study