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Preoperative IMRT With Concurrent Apatinib for Localised Extremity or Trunk Sarcoma

Primary Purpose

Sarcoma,Soft Tissue, Extremity, Trunk

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Apatinib Mesylate

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 Apatinib
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 Apatinib, including allergic to Apatinib, 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

Apatinib arm

Arm Description

Apatinib 500mg QD, used 2 weeks prior to IMRT, concurrent with pre-operative IMRT, and 1 month after end of IMRT

Outcomes

Primary Outcome Measures

Rate of Major wound complications within 4 months post-surgery

Secondary Outcome Measures

Acute and late toxicities

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Patient-reported Quality of Life assessed by EORTC-QLQ-C30 questionnaire

Evaluate the quality of life by patient-reported EORTC-QLQ-C30 questionnaire at different time points

Extremity function scores

Evaluate the extremity function by MSTS (Musculoskeletal Tumor Rating Scale) and TESS (Toronto Extremity Salvage Score) forms at different time points

Pathological remission rate

Evaluate the tumor remission rate microscopically 2 weeks after operation

Local control

Overall survival

Full Information

NCT ID

NCT05235100

First Posted

December 2, 2021

Last Updated

February 8, 2022

Sponsor

Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT05235100

Brief Title

Preoperative IMRT With Concurrent Apatinib for Localised Extremity or Trunk Sarcoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2021 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

December 2024 (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 Apatinib 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 Apatinib 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, Intensity-modulated Radiotherapy, Targetd Therapy, 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

Apatinib arm

Arm Type

Experimental

Arm Description

Apatinib 500mg QD, used 2 weeks prior to IMRT, concurrent with pre-operative IMRT, and 1 month after end of IMRT

Intervention Type

Drug

Intervention Name(s)

Apatinib Mesylate

Intervention Description

Apatinib Mesylate 500mg QD, begin from 2 weeks prior to IMRT, to 1 month after end of IMRT

Primary Outcome Measure Information:

Title

Rate of Major wound complications within 4 months post-surgery

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

Patient-reported Quality of Life assessed by EORTC-QLQ-C30 questionnaire

Description

Evaluate the quality of life by patient-reported EORTC-QLQ-C30 questionnaire at different time points

Time Frame

From date of enrollment to 2 years after surgery, specifically at pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up up to 2 years post-surgery

Title

Extremity function scores

Description

Evaluate the extremity function by MSTS (Musculoskeletal Tumor Rating Scale) and TESS (Toronto Extremity Salvage Score) forms at different time points

Time Frame

From date of enrollment to 2 years after surgery, specifically at pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up up to 2 years post-surgery

Title

Pathological remission rate

Description

Evaluate the tumor remission rate microscopically 2 weeks after operation

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 Apatinib 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 Apatinib, including allergic to Apatinib, 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, M.D.

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: