Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
NCT Number: NCT05235100
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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Notify Me18 year and older
All sexes
Interventional
Phase 2
Beijing, Beijing Municipality, 100021, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Apatinib Mesylate 500mg QD, begin from 2 weeks prior to IMRT, to 1 month after end of IMRT
Time frame: 4-months post-surgery
Time frame: acute toxicities were evaluated during and 3 months after IMRT, late toxicities were evaluted after 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 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
Evaluate the quality of life by patient-reported EORTC-QLQ-C30 questionnaire at different time points
Time frame: 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
Evaluate the extremity function by MSTS (Musculoskeletal Tumor Rating Scale) and TESS (Toronto Extremity Salvage Score) forms at different time points
Time frame: 2 weeks after operation
Evaluate the tumor remission rate microscopically 2 weeks after operation
Time frame: 2-year
Time frame: 2-year
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Other
Preoperative Intensity-modulated Radiotherapy (IMRT) With Concurrent Apatinib Mesylate for Localised Extremity or Trunk Sarcoma
Acronym: SPARE-02
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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