Preoperative IMRT With Concurrent Anlotinib for Localised Extremity or Trunk Sarcoma

Sarcoma,Soft Tissue Clinical Trial

Official title:

Preoperative Intensity-modulated Radiotherapy (IMRT) With Concurrent Anlotinib Hydrochloride for Localised Extremity or Trunk Sarcoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05167994
• Other study ID #: NCC2333
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2021
• Source: Chinese Academy of Medical Sciences
• Contact: Ning-Ning Lu
• Phone: +868611804268
• Email: Ning-Ning.Lu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anlotinib
• Sarcoma
• Sarcoma,Soft Tissue

Intervention

Drug:
• Anlotinib hydrochloride
Anlotinib 12mgQD, from D1 of pre-operative IMRT to 1 month after end of IMRT

Locations

Country	Name	City	State
China	Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major wound complications		4-months post-surgery
Secondary	Acute and late toxicities	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	acute toxicities were evaluated during and 3 months after IMRT, late toxicities were evaluted after 6 months
Secondary	Quality of Life	Evaluate quality of life by QOL questionnaires at different time points	pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up
Secondary	Extremity function	Evaluate quality of life by MSTS forms at different time points	pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up
Secondary	Pathological remission rate	evaluate the tumor remission rate microscopically	2 weeks after operation
Secondary	Local control		2-year
Secondary	Overall Survival		2-year