Preoperative IMRT With Concurrent Anlotinib for Localised Extremity or Trunk Sarcoma
Primary Purpose
Sarcoma,Soft Tissue, Extremity, Trunk
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anlotinib hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Sarcoma,Soft Tissue
Eligibility Criteria
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.
Sites / Locations
- Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anlotinib arm
Arm Description
Pre-operative IMRT with concurrent and sequential Anlotinib
Outcomes
Primary Outcome Measures
Major wound complications
Secondary Outcome Measures
Acute and late toxicities
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Quality of Life
Evaluate quality of life by QOL questionnaires at different time points
Extremity function
Evaluate quality of life by MSTS forms at different time points
Pathological remission rate
evaluate the tumor remission rate microscopically
Local control
Overall Survival
Full Information
NCT ID
NCT05167994
First Posted
December 2, 2021
Last Updated
December 20, 2021
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05167994
Brief Title
Preoperative IMRT With Concurrent Anlotinib for Localised Extremity or Trunk Sarcoma
Official Title
Preoperative Intensity-modulated Radiotherapy (IMRT) With Concurrent Anlotinib Hydrochloride for Localised Extremity or Trunk Sarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma,Soft Tissue, Extremity, Trunk, Anlotinib, Intensity-modulated Radiotherapy, Major Wound Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anlotinib arm
Arm Type
Experimental
Arm Description
Pre-operative IMRT with concurrent and sequential Anlotinib
Intervention Type
Drug
Intervention Name(s)
Anlotinib hydrochloride
Intervention Description
Anlotinib 12mgQD, from D1 of pre-operative IMRT to 1 month after end of IMRT
Primary Outcome Measure Information:
Title
Major wound complications
Time Frame
4-months post-surgery
Secondary Outcome Measure Information:
Title
Acute and late toxicities
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
acute toxicities were evaluated during and 3 months after IMRT, late toxicities were evaluted after 6 months
Title
Quality of Life
Description
Evaluate quality of life by QOL questionnaires at different time points
Time Frame
pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up
Title
Extremity function
Description
Evaluate quality of life by MSTS forms at different time points
Time Frame
pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up
Title
Pathological remission rate
Description
evaluate the tumor remission rate microscopically
Time Frame
2 weeks after operation
Title
Local control
Time Frame
2-year
Title
Overall Survival
Time Frame
2-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ning-Ning Lu
Phone
+868611804268
Email
Ning-Ning.Lu@hotmail.com
Facility Information:
Facility Name
Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ningning Lu, Doctor
Phone
+86 01087787630
Email
Ning-Ning.Lu@hotmail.com
First Name & Middle Initial & Last Name & Degree
Shu-Lian Wang, M.D.
Phone
+86 01087788280
Email
wsl20040118@yahoo.com
First Name & Middle Initial & Last Name & Degree
Shu-Lian Wang, M.D
First Name & Middle Initial & Last Name & Degree
Sheng-Ji Yu, M.D
First Name & Middle Initial & Last Name & Degree
Ning-Ning Lu, M.D.
12. IPD Sharing Statement
Learn more about this trial
Preoperative IMRT With Concurrent Anlotinib for Localised Extremity or Trunk Sarcoma
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