Spatially Fractionated Radiotherapy Versus Conventional Radiotherapy in the Treatment of Soft Tissue Sarcoma

NARecruitingINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

May 20, 2025

Primary Completion Date

May 20, 2027

Study Completion Date

May 20, 2028

Conditions
Soft Tissue Sarcoma (STS)
Interventions
RADIATION

Spatially Fractionated Radiotherapy

SFRT builds on CRT, administered at 3.0 Gy per fraction for 15-20 fractions, with the addition of weekly high-dose vertices of 8-15 Gy per fraction for 3-4 fractions. It employs Intensity-Modulated Radiation Therapy (IMRT), Intensity-Modulated Proton Therapy (IMPT), or Volumetric Modulated Arc Therapy (VMAT) to create a grid-like pattern of alternating high- and low-dose regions. Target volume delineation includes the gross tumor volume (GTV), clinical target volume (CTV, expanded 0.5-1.0 cm from GTV), and planning target volume (PTV, expanded 1.0 cm from CTV). Prior to each treatment session, cone-beam CT (CBCT) or kilovoltage cone-beam CT (kV-CBCT) is used for Image-Guided Radiation Therapy (IGRT) to verify patient positioning.

RADIATION

Conventional Radiotherapy

CRT is delivered at 3.0 Gy per fraction for a total of 15-20 fractions, utilizing Intensity-Modulated Radiation Therapy (IMRT) or Intensity-Modulated Proton Therapy (IMPT) techniques, ensuring a target volume dose coverage of at least 90%. Target volume delineation includes the gross tumor volume (GTV), clinical target volume (CTV, expanded 0.5-1.0 cm from GTV), and planning target volume (PTV, expanded 1.0 cm from CTV). Prior to each treatment session, cone-beam CT (CBCT) or kilovoltage cone-beam CT (kV-CBCT) is used for Image-Guided Radiation Therapy (IGRT) to verify patient positioning.

Trial Locations (1)

0531

RECRUITING

Shandong Cancer Hospital and Institute, Jinan

All Listed Sponsors
lead

Shandong Cancer Hospital and Institute

OTHER