Skip to main content
OpenTrials
Completed

NCT Number: NCT05235100

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apatinib Mesylate

Drug

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

Primary outcomes

  1. Rate of Major wound complications within 4 months post-surgery

    Time frame: 4-months post-surgery

Secondary outcomes

  1. Acute and late toxicities

    Time frame: 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

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

    Time frame: 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

    Evaluate the quality of life by patient-reported EORTC-QLQ-C30 questionnaire at different time points

  3. Extremity function scores

    Time frame: 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

    Evaluate the extremity function by MSTS (Musculoskeletal Tumor Rating Scale) and TESS (Toronto Extremity Salvage Score) forms at different time points

  4. Pathological remission rate

    Time frame: 2 weeks after operation

    Evaluate the tumor remission rate microscopically 2 weeks after operation

  5. Local control

    Time frame: 2-year

  6. Overall survival

    Time frame: 2-year

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Collaborators

  • Beijing Jishuitan Hospital

Registry information

Official study title

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

Acronym: SPARE-02

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 10, 2022
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.