Preoperative IMRT With Concurrent Anlotinib for Localised Extremity or Trunk Sarcoma

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anlotinib; Sarcoma,Soft Tissue; Trunk; Extremity; Intensity-modulated Radiotherapy; Major Wound Complications
• Intervention / Treatment: Drug: Anlotinib hydrochloride

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Anlotinib arm; Pre-operative IMRT with concurrent and sequential Anlotinib	Drug: Anlotinib hydrochloride; Anlotinib 12mgQD, from D1 of pre-operative IMRT to 1 month after end of IMRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Major wound complications	4-months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute and late toxicities	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	acute toxicities were evaluated during and 3 months after IMRT, late toxicities were evaluted after 6 months
Quality of Life	Evaluate quality of life by QOL questionnaires at different time points	pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up
Extremity function	Evaluate quality of life by MSTS forms at different time points	pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up
Pathological remission rate	evaluate the tumor remission rate microscopically	2 weeks after operation
Local control		2-year
Overall Survival		2-year

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2020
• Primary Completion (ANTICIPATED): April 30, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (ACTUAL): December 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 22, 2021
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma
• Other Study ID Numbers: NCC2333

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No