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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: Anlotinib hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT05167994

NCC2333

Details and patient eligibility

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Anlotinib arm

Experimental group

Description:

Pre-operative IMRT with concurrent and sequential Anlotinib

Treatment:

Drug: Anlotinib hydrochloride