Preoperative IMRT With Concurrent Anlotinib 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 Anlotinib Hydrochloride 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 Anlotinib Hydrochloride 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 Anlotinib Hydrochloride for Localised Extremity or Trunk Sarcoma

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

Intervention / Treatment
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* Drug: Anlotinib hydrochloride


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 Anlotinib 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 Anlotinib, including allergic to Anlotinb, 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: Anlotinib arm<br>Pre-operative IMRT with concurrent and sequential Anlotinib | Drug: Anlotinib hydrochloride<br>* Anlotinib 12mgQD, from D1 of pre-operative 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 |
| --- | --- | --- |
| Major wound complications |  | 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 | 
| Quality of Life | Evaluate quality of life by QOL questionnaires at different time points | pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up | 
| Extremity function | Evaluate quality of life by MSTS forms at different time points | pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up | 
| Pathological remission rate | evaluate the tumor remission rate microscopically | 2 weeks after operation | 
| Local control |  | 2-year | 
| Overall Survival |  | 2-year |