RecruitingPhase 2NCT06593899

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


Sponsor

Fujian Medical University Union Hospital

Enrollment

51 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a total neoadjuvant therapy approach — meaning radiation and chemotherapy given before surgery — for people with large, deep, or high-grade soft tissue sarcomas (a rare cancer of connective tissues) in the arms or legs. **You may be eligible if...** - You have been diagnosed with a primary soft tissue sarcoma in an arm or leg - Your tumor is high grade, 5 cm or larger, or located deep in the tissue, and your medical team has determined neoadjuvant radiation is needed - You are between 18 and 75 years old - Your general health is good enough to tolerate treatment (ECOG 0-2) - Your major organs are functioning normally **You may NOT be eligible if...** - You have already had surgery at another hospital that left no visible tumor - You have other serious conditions preventing chemotherapy - You have had another cancer in the past 5 years (except for certain early-stage skin or cervical cancers) - Your sarcoma is a specific rare type (rhabdomyosarcoma or Ewing sarcoma) - The cancer has spread to lymph nodes or other organs - You previously received radiation to the same area or chemotherapy for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHypofractionated Radiotherapy

Hypofractionated radiotherapy Preoperative hypofractionated 5x5 Gy radiotherapy (5 consecutive days) prescribed on planned target volume

DRUG3 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

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NCT06593899


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