RecruitingPhase 2NCT05167994

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

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


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

30 participants

Start Date

May 1, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding the drug anlotinib (an anti-cancer targeted therapy) to radiation therapy before surgery improves outcomes in people with soft tissue sarcoma of the limbs or trunk — a rare type of cancer affecting connective tissue. **You may be eligible if...** - You are over 18 years old - You have a confirmed soft tissue sarcoma of the arm, leg, or trunk (torso) - Your cancer has been reviewed by a specialist pathologist and deemed suitable for preoperative radiation and limb-sparing surgery - You are in reasonable health (ECOG 0–3) - You are willing to use contraception **You may NOT be eligible if...** - You have already had your tumor removed elsewhere - You have conditions that would make anlotinib unsafe (e.g., active bleeding, uncontrolled high blood pressure, severe heart or liver problems) - Your tumor is a type excluded from the study (e.g., DFSP, desmoid tumor) - You have another cancer diagnosed in the past 5 years - There is evidence of cancer spread to other parts of the body - You have already received radiation to the same area Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnlotinib hydrochloride

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


Locations(1)

Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT05167994


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