Preoperative IMRT With Concurrent Apatinib for Localised Extremity or Trunk Sarcoma （SPARE-02）

NCT05235100 | Completed Phase 2

• 1 other identifier: NCC-007196
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcoma,Soft Tissue; Extremity; Trunk; Intensity-modulated Radiotherapy; Targetd Therapy; Major Wound Complications

Outcome Measures

Primary Outcomes (1)

• Rate of Major wound complications within 4 months post-surgery

  4-months post-surgery

Secondary Outcomes (6)

• Acute and late toxicities

  acute toxicities were evaluated during and 3 months after IMRT, late toxicities were evaluted after 6 months

• Patient-reported Quality of Life assessed by EORTC-QLQ-C30 questionnaire

  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

• Extremity function scores

  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

• Pathological remission rate

  2 weeks after operation

• Local control

  2-year

Study Arms (1)

Apatinib arm

EXPERIMENTAL

Apatinib 500mg QD, used 2 weeks prior to IMRT, concurrent with pre-operative IMRT, and 1 month after end of IMRT

Drug: Apatinib Mesylate

Interventions

Apatinib Mesylate DRUG

Apatinib Mesylate 500mg QD, begin from 2 weeks prior to IMRT, to 1 month after end of IMRT

Apatinib arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Beijing Jishuitan Hospital: collaborator

Study Sites (1)

Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Sarcoma

Interventions

apatinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: February 10, 2022
• Study Start: September 1, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

CN (1)