Preoperative IMRT With Concurrent Apatinib for Localised Extremity or Trunk Sarcoma

Study Overview
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Brief Summary
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To investigate the safety and efficacy of preoperative IMRT and concurrent Apatinib 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 Apatinib for primary truncal or extremity soft tissue sarcoma; To assess the relationship between the MRI imaging, pathological findings and local control.

Official Title
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Preoperative Intensity-modulated Radiotherapy (IMRT) With Concurrent Apatinib Mesylate for Localised Extremity or Trunk Sarcoma

Conditions
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Trunk, Sarcoma,Soft Tissue, Extremity, Intensity-modulated Radiotherapy, Targetd Therapy, Major Wound Complications

Intervention / Treatment
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* Drug: Apatinib Mesylate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age older than 18-yo. Histology proven soft tissue sarcoma of truncal or extremity, deemed appropriate for preoperative radiotherapy and conservative surgery by multidisciplinary discussion. ECOG 0-3 Histology reviewed by reference pathologist Lesion can be assessed Can tolerate radiotherapy and Apatinib Agree contraception. Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed Exclusion Criteria: No gross tumor post-resection in other center. Contraindications to Apatinib, including allergic to Apatinib, active bleeding, ulcer, enteric perforation, enteric obstruction, uncontrolled hypertension, Grade 3 to 4 cardiac insufficiency (per NYHA criteria), and severe hepatic or renal insufficiency (Grade 4), etc. Dermatofibrosarcoma protuberans(DFSP), Desmoids, etc. Benign histology Secondary cancer within 5 years (except cervical carcinoma in situ or early-stage skin basal cell carcinoma) STS can be cured by extensive operation alone. Previous irradiation to the same area radiological evidence of distant metastases Other contraindications, can't tolerate operation or other treatment needed in this study. Neoadjuvant chemotherapy given or planned.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apatinib arm<br>Apatinib 500mg QD, used 2 weeks prior to IMRT, concurrent with pre-operative IMRT, and 1 month after end of IMRT | Drug: Apatinib Mesylate<br>* Apatinib Mesylate 500mg QD, begin from 2 weeks prior to IMRT, to 1 month after end of IMRT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Major wound complications within 4 months post-surgery |  | 4-months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute and late toxicities | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | acute toxicities were evaluated during and 3 months after IMRT, late toxicities were evaluted after 6 months | 
| Patient-reported Quality of Life assessed by EORTC-QLQ-C30 questionnaire | Evaluate the quality of life by patient-reported EORTC-QLQ-C30 questionnaire at different time points | From date of enrollment to 2 years after surgery, specifically at pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up up to 2 years post-surgery | 
| Extremity function scores | Evaluate the extremity function by MSTS (Musculoskeletal Tumor Rating Scale) and TESS (Toronto Extremity Salvage Score) forms at different time points | From date of enrollment to 2 years after surgery, specifically at pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up up to 2 years post-surgery | 
| Pathological remission rate | Evaluate the tumor remission rate microscopically 2 weeks after operation | 2 weeks after operation | 
| Local control |  | 2-year | 
| Overall survival |  | 2-year |