Preoperative IMRT With Concurrent Anlotinib for Localised Extremity or Trunk Sarcoma

Phase 2

• Conditions: Major Wound Complications; Anlotinib; Sarcoma,Soft Tissue; Intensity-modulated Radiotherapy; Extremity; Trunk
• Interventions: Drug: Anlotinib hydrochloride

• Registration Number: NCT05167994
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-01
• Status Verified: 2021-12
• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-20
• Last Update Submitted: 2021-12-20
• Study First Posted: 2021-12-22
• Last Update Posted: 2021-12-22
• Primary Completion: 2023-04-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anlotinib arm	Anlotinib hydrochloride	Pre-operative IMRT with concurrent and sequential Anlotinib

Primary Outcome Measures

Name	Time	Method
Major wound complications	4-months post-surgery

Secondary Outcome Measures

Name	Time	Method
Overall Survival	2-year
Pathological remission rate	2 weeks after operation	evaluate the tumor remission rate microscopically
Acute and late toxicities	acute toxicities were evaluated during and 3 months after IMRT, late toxicities were evaluted after 6 months	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Extremity function	pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up	Evaluate quality of life by MSTS forms at different time points
Local control	2-year
Quality of Life	pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up	Evaluate quality of life by QOL questionnaires at different time points

Trial Locations

Locations (1)

Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China