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

NCT05167994 | Recruiting Phase 2

• 1 other identifier: NCC2333
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Major wound complications

  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

• Quality of Life

  pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up

• Extremity function

  pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up

• Pathological remission rate

  2 weeks after operation

• Local control

  2-year

Study Arms (1)

Anlotinib arm

EXPERIMENTAL

Pre-operative IMRT with concurrent and sequential Anlotinib

Drug: Anlotinib hydrochloride

Interventions

Anlotinib hydrochloride DRUG

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

Anlotinib 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 Anlotinib
• 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 Anlotinib, including allergic to Anlotinb, 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

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

Study Sites (1)

Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ning-Ning Lu

CONTACT

+868611804268; Ning-Ning.Lu@hotmail.com

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: December 22, 2021
• Study Start: May 1, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

CN (1)