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OncoMatch/Clinical Trials/NCT06593899

The Total Neoadjuvant Therapy for Soft Tissue Sarcoma of the Extremities

Is NCT06593899 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies 3 cycles of AI for soft tissue sarcomas.

Phase 2RecruitingFujian Medical University Union HospitalNCT06593899Data as of May 2026

Treatment: 3 cycles of AIFor 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

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Extracted eligibility criteria

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: radiation therapy

Exception: previous history of radiotherapy to the same site

Previous history of radiotherapy to the same site

Cannot have received: cytotoxic chemotherapy

Previous exposure to chemotherapy

Lab requirements

Kidney function

severe renal insufficiency (Level IV) excluded

Liver function

severe liver insufficiency (Level IV) excluded

Cardiac function

grade III-IV cardiac insufficiency (NYHA standards) excluded

The function of major organs is normal; severe liver and renal insufficiency (Level IV) etc.; grade III-IV cardiac insufficiency (NYHA standards)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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