Status:
COMPLETED
Preoperative IMRT With Concurrent Apatinib for Localised Extremity or Trunk Sarcoma （SPARE-02）
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborating Sponsors:
Beijing Jishuitan Hospital
Conditions:
Sarcoma,Soft Tissue
Extremity
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05235100
Start Date
September 1 2021
End Date
August 31 2024
Last Update
December 11 2025
Active Locations (1)
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1
Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021