Preoperative IMRT With Concurrent Apatinib for Localised Extremity or Trunk Sarcoma （SPARE-02）

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT05235100
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apatinib Mesylate — DRUG
    Apatinib Mesylate 500mg QD, begin from 2 weeks prior to IMRT, to 1 month after end of IMRT

Study Details

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.

Key Dates

Start date
Sep 1, 2021
Status verified
Dec 2025
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib arm
    Apatinib 500mg QD, used 2 weeks prior to IMRT, concurrent with pre-operative IMRT, and 1 month after end of IMRT

Primary Outcome Measure

Rate of Major wound complications within 4 months post-surgery [ Time Frame: 4-months post-surgery ]

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