Preoperative IMRT With Concurrent Anlotinib for Localised Extremity or Trunk Sarcoma

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.