NCT05938374

Preoperative Moderately Fractionated IMRT for Locally Extremity or Trunk Sarcoma (SPARE-03)

Preoperative Moderately Fractionated Intensity-modulated Radiotherapy (IMRT) With/Without Concurrent Fluzoparil for Locally Extremity or Trunk Sarcoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate the safety and efficacy of preoperative moderately fractionated IMRT and concurrent Fluzoparib Hydrochloride for primary truncal or extremity soft tissue sarcoma.

Detailed description

To investigate the safety and efficacy of preoperative moderately fractionated IMRT and concurrent Fluzoparib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To investigate the Quality of life and extremity function post-combination treatment; To study the mechanism of radio-sensitizing effects of Fluzoparib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To assess the relationship between the MRI imaging, pathological findings and local control.

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Fluzoparib	One week before RT onset, during radiotherapy and 5 weeks post-RT, patients also take oral Fluzoparib (100mg, BID, five days per week).
RADIATION	Preoperative moderately fractionated radiotherapay	Patients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr).

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-07-10
• Last updated: 2025-12-11

Locations

2 sites across 1 country: China