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| Name | Class |
|---|---|
| Beijing Jishuitan Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib arm | Experimental | Apatinib 500mg QD, used 2 weeks prior to IMRT, concurrent with pre-operative IMRT, and 1 month after end of IMRT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib Mesylate | Drug | Apatinib Mesylate 500mg QD, begin from 2 weeks prior to IMRT, to 1 month after end of IMRT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Major wound complications within 4 months post-surgery | 4-months post-surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China |
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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 |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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