Overview

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.