Preoperative IMRT With Concurrent Anlotinib for Localised Extremity or Trunk Sarcoma （SPARE-01）
Preoperative Intensity-modulated Radiotherapy (IMRT) With Concurrent Anlotinib Hydrochloride for Localised Extremity or Trunk Sarcoma
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
30 participants
May 1, 2020
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- 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 Criteria10
- 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.
Interventions
Anlotinib 12mgQD, from D1 of pre-operative IMRT to 1 month after end of IMRT
Locations(1)
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NCT05167994