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Preoperative Moderately Fractionated IMRT for Locally Extremity or Trunk Sarcoma

Primary Purpose

Soft Tissue Sarcoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fluzoparib
Preoperative moderately fractionated radiotherapay
Sponsored by
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Sarcoma focused on measuring soft tissue sarcoma, preoperative radiotherapy, moderately fractionated RT, Complications, PARP inhibitor

Eligibility Criteria

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

Inclusion Criteria: Age older than 18 years. 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 Fluzoparib (Fluzoparib group) 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 Fluzoparib, including allergic to Fluzoparib, 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.

Sites / Locations

  • Beijing Jishuitan HospitalRecruiting
  • Cancer Hospital and Institute, National Cancer Center, Chinese Academy of Medical Sciences & Peking Union Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Preoperative moderately fractionated RT with Fluzoparib

Preoperative moderately fractionated RT without Fluzoparib

Arm Description

Patients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr). One week before RT onset, during radiotherapy and 5 weeks post-RT, patients also take oral Fluzoparib (100mg, BID, five days per week). Wide resection surgery would be done around 6 -10 weeks post-RT.

Patients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr). No radio-sensitizing drugs was given. Wide resection surgery would be done around 6 -10 weeks post-RT.

Outcomes

Primary Outcome Measures

Major wound complications
Number of Participants with Major wound complications 4 months post-surgery

Secondary Outcome Measures

Acute toxicities
acute toxicities were evaluated as per CTCAE V5.0 criteria weekly during IMRT and 1 months after IMRT
Late toxicities
late toxicities were evaluted as per CTCAE V5.0 criteria and RTOG scale after 6 months
Quality of Life
EORTC QLQ-C30 questionnaire
Extremity function
MSTS questionnaire, TESS questionnaire
Pathological complete remission rate
No residual tumor cells were observed on post-operative specimens
2-year overall survival
Incidence of participants who were alive
2-year local control
Incidence of participants who had no Local relapse

Full Information

First Posted
June 21, 2023
Last Updated
July 3, 2023
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborators
Beijing Jishuitan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05938374
Brief Title
Preoperative Moderately Fractionated IMRT for Locally Extremity or Trunk Sarcoma
Official Title
Preoperative Moderately Fractionated Intensity-modulated Radiotherapy (IMRT) With/Without Concurrent Fluzoparil for Locally Extremity or Trunk Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
April 30, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborators
Beijing Jishuitan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To investigate the safety and efficacy of preoperative moderately fractionated IMRT and concurrent Fluzoparib Hydrochloride for primary truncal or extremity soft tissue sarcoma.
Detailed Description
To investigate the safety and efficacy of preoperative moderately fractionated IMRT and concurrent Fluzoparib 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 Fluzoparib 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
Soft Tissue Sarcoma
Keywords
soft tissue sarcoma, preoperative radiotherapy, moderately fractionated RT, Complications, PARP inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Preoperative moderately fractionated RT with Fluzoparib Preoperative moderately fractionated RT without Fluzoparib
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preoperative moderately fractionated RT with Fluzoparib
Arm Type
Experimental
Arm Description
Patients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr). One week before RT onset, during radiotherapy and 5 weeks post-RT, patients also take oral Fluzoparib (100mg, BID, five days per week). Wide resection surgery would be done around 6 -10 weeks post-RT.
Arm Title
Preoperative moderately fractionated RT without Fluzoparib
Arm Type
Experimental
Arm Description
Patients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr). No radio-sensitizing drugs was given. Wide resection surgery would be done around 6 -10 weeks post-RT.
Intervention Type
Drug
Intervention Name(s)
Fluzoparib
Other Intervention Name(s)
RT+Fluzoparib
Intervention Description
One week before RT onset, during radiotherapy and 5 weeks post-RT, patients also take oral Fluzoparib (100mg, BID, five days per week).
Intervention Type
Radiation
Intervention Name(s)
Preoperative moderately fractionated radiotherapay
Other Intervention Name(s)
RT
Intervention Description
Patients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr).
Primary Outcome Measure Information:
Title
Major wound complications
Description
Number of Participants with Major wound complications 4 months post-surgery
Time Frame
4-months post-surgery
Secondary Outcome Measure Information:
Title
Acute toxicities
Description
acute toxicities were evaluated as per CTCAE V5.0 criteria weekly during IMRT and 1 months after IMRT
Time Frame
pre-IMRT, weekly during IMRT, at the end of IMRT, 1 months post-IMRT
Title
Late toxicities
Description
late toxicities were evaluted as per CTCAE V5.0 criteria and RTOG scale after 6 months
Time Frame
6 months, 9 months, 12 months, 18 months and 24 months after surgery
Title
Quality of Life
Description
EORTC QLQ-C30 questionnaire
Time Frame
pre-IMRT, end of IMRT, 1 months post-IMRT, and then 3 months, 6 months, 9 months, 12 months, 18 months and 24 months after surgery
Title
Extremity function
Description
MSTS questionnaire, TESS questionnaire
Time Frame
pre-IMRT, end of IMRT, 1 months post-IMRT, and then 3 months, 6 months, 9 months, 12 months, 18 months and 24 months after surgery
Title
Pathological complete remission rate
Description
No residual tumor cells were observed on post-operative specimens
Time Frame
2 weeks after surgery
Title
2-year overall survival
Description
Incidence of participants who were alive
Time Frame
2 year since enrollment
Title
2-year local control
Description
Incidence of participants who had no Local relapse
Time Frame
2 year since enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age older than 18 years. 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 Fluzoparib (Fluzoparib group) 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 Fluzoparib, including allergic to Fluzoparib, 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ning-Ning Lu, Dr.
Phone
0118613051396569
Email
Ning-Ning.Lu@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lu-Qiang Wang, Dr.
Email
wangluqiang_lm@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ning-Ning Lu, Dr.
Organizational Affiliation
Cancer Hospital and Institute, National Cancer Center, CAMS& PUMC, Beijing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Jishuitan Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Jin, Dr.
First Name & Middle Initial & Last Name & Degree
Zhuo-Yu Li
First Name & Middle Initial & Last Name & Degree
Wei-Feng Liu, Dr.
First Name & Middle Initial & Last Name & Degree
Qing Zhang, Dr.
Facility Name
Cancer Hospital and Institute, National Cancer Center, Chinese Academy of Medical Sciences & Peking Union Medical Center
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning-Ning Lu, Dr.
Phone
0118613051396569
Email
Ning-Ning.Lu@hotmail.com
First Name & Middle Initial & Last Name & Degree
Lu-Qiang Wang, Dr.
Email
wangluqiang_lm@163.com
First Name & Middle Initial & Last Name & Degree
Ning-Ning Lu, Dr.
First Name & Middle Initial & Last Name & Degree
Sheng-Ji Yu, Dr.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Preoperative Moderately Fractionated IMRT for Locally Extremity or Trunk Sarcoma

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