NCT06593899

The Total Neoadjuvant Therapy for Soft Tissue Sarcoma of the Extremities

The Total Neoadjuvant Therapy for Hypofractionated Radiotherapy Combined with AI Regimens in Soft Tissue Sarcoma of the Extremities: a Phase 2 Single Arm Multicenter Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Fujian Medical University Union Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

For localized soft tissue sarcomas (STS) of the extremities, limb-sparing or conservative surgery with perioperative radiotherapy (RT) is the standard of care. However, several challenges persist. Notably, there are exceedingly high rates of distant metastatic recurrence even after surgical resection and RT, and conventional fractionated radiotherapy has a prolonged duration (5-6 weeks). With advancements in RT technology, the gradual expansion of hypofractionated radiotherapy regimens enables significantly shorter treatment durations. Promising recent reports on 1-week hypofractionated RT regimens, such as the 5X5 Gy RT regimens, have demonstrated reasonable local control and acceptable toxicity in resectable STS.Addressing the challenge of distant metastasis, previous studies have indicated that AI regimens are expected to eliminate micrometastases and improve survival in patients with STS at a high risk of distant relapse. Therefore, the goal of this clinical trial is to investigate whether hypofractionated RT combined with a sequential chemotherapy（AI regimens）can enhance short-term treatment efficacy for extremity STS patients without compromising local control rates and increasing related toxicities

Conditions

• Soft Tissue Sarcomas

Interventions

Type	Name	Description
RADIATION	Hypofractionated Radiotherapy	Hypofractionated radiotherapy Preoperative hypofractionated 5x5 Gy radiotherapy (5 consecutive days) prescribed on planned target volume
DRUG	3 cycles of AI	Three courses of doxorubicin and ifosfamide (AI, doxorubicin 75 mg/sqm and ifosfamide 10 g/sqm with prophylactic mesna)

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-12-01
• Completion: 2026-07-01
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: China