Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05167994

Preoperative IMRT With Concurrent Anlotinib for Localised Extremity or Trunk Sarcoma (SPARE-01)

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-12-11

30

Participants Needed

1

Research Sites

400 weeks

Total Duration

On this page

Sponsors

C

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead Sponsor

B

Beijing Jishuitan Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Preoperative IMRT With Concurrent Anlotinib for Localised Extremity or Trunk Sarcoma (SPARE-01)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age older than 18 years
  • Histologically confirmed soft tissue sarcoma of trunk or extremity suitable for preoperative radiotherapy and conservative surgery
  • ECOG performance status of 0 to 3
  • Histology reviewed by a reference pathologist
  • Lesion can be assessed
  • Able to tolerate radiotherapy and Anlotinib treatment
  • Agree to use contraception
  • Signed informed consent indicating understanding of the study and its risks
Not Eligible

You will not qualify if you...

  • No gross tumor remaining after prior surgery at another center
  • Contraindications to Anlotinib, including allergy, active bleeding, ulcers, enteric perforation or obstruction, uncontrolled hypertension, severe heart failure, or severe liver or kidney problems
  • Diagnosis of dermatofibrosarcoma protuberans, desmoids, or benign tumors
  • Secondary cancer within the past 5 years (except cervical carcinoma in situ or early-stage skin basal cell carcinoma)
  • Soft tissue sarcoma curable by extensive surgery alone
  • Previous radiation to the same area
  • Evidence of distant metastases on imaging
  • Other contraindications or inability to tolerate surgery or study treatments
  • Neoadjuvant chemotherapy given or planned

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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2
3
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Trial Site Locations

Total: 1 location

1

Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

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Research Team

N

Ning-Ning Lu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Preoperative IMRT With Concurrent Anlotinib for Localised Extremity or Trunk Sarcoma (SPARE-01) | DecenTrialz