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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

About this trial

This is an interventional treatment trial for Sarcoma,Soft Tissue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

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

Studies a U.S. FDA-regulated Device Product

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

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

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: