Preoperative IMRT With Concurrent Apatinib for Localised Extremity or Trunk Sarcoma

Sarcoma,Soft Tissue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05235100
• Other study ID #: NCC-007196
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: February 2022
• Source: Chinese Academy of Medical Sciences
• Contact: Ning-Ning Lu, M.D.
• 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 Apatinib 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 Apatinib 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 2024
• Est. primary completion date: August 2024
• 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 Apatinib

• 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 Apatinib, including allergic to Apatinib, 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

• Sarcoma
• Sarcoma,Soft Tissue

Intervention

Drug:
• Apatinib Mesylate
Apatinib Mesylate 500mg QD, begin from 2 weeks prior to 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	Rate of Major wound complications within 4 months post-surgery		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	Patient-reported Quality of Life assessed by EORTC-QLQ-C30 questionnaire	Evaluate the quality of life by patient-reported EORTC-QLQ-C30 questionnaire at different time points	From date of enrollment to 2 years after surgery, specifically at pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up up to 2 years post-surgery
Secondary	Extremity function scores	Evaluate the extremity function by MSTS (Musculoskeletal Tumor Rating Scale) and TESS (Toronto Extremity Salvage Score) forms at different time points	From date of enrollment to 2 years after surgery, specifically at pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up up to 2 years post-surgery
Secondary	Pathological remission rate	Evaluate the tumor remission rate microscopically 2 weeks after operation	2 weeks after operation
Secondary	Local control		2-year
Secondary	Overall survival		2-year