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The Total Neoadjuvant Therapy for Soft Tissue Sarcoma of the Extremities
Sponsor: Fujian Medical University Union Hospital
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
51
Start Date
2024-05-01
Completion Date
2026-07-01
Last Updated
2024-09-19
Healthy Volunteers
No
Conditions
Interventions
Hypofractionated Radiotherapy
Hypofractionated radiotherapy Preoperative hypofractionated 5x5 Gy radiotherapy (5 consecutive days) prescribed on planned target volume
3 cycles of AI
Three courses of doxorubicin and ifosfamide (AI, doxorubicin 75 mg/sqm and ifosfamide 10 g/sqm with prophylactic mesna)
Locations (1)
Fujian Medical University Union Hospital
Fuzhou, Fujian, China