Preoperative Moderately Fractionated IMRT for Locally Extremity or Trunk Sarcoma

July 3, 2023 updated by: NINGNING LU, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Preoperative Moderately Fractionated Intensity-modulated Radiotherapy (IMRT) With/Without Concurrent Fluzoparil for Locally Extremity or Trunk Sarcoma

To investigate the safety and efficacy of preoperative moderately fractionated IMRT and concurrent Fluzoparib Hydrochloride for primary truncal or extremity soft tissue sarcoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Jishuitan Hospital
        • Contact:
          • Tao Jin, Dr.
        • Contact:
          • Zhuo-Yu Li
        • Principal Investigator:
          • Wei-Feng Liu, Dr.
        • Sub-Investigator:
          • Qing Zhang, Dr.
      • Beijing, Beijing, China
        • Recruiting
        • Cancer Hospital and Institute, National Cancer Center, Chinese Academy of Medical Sciences & Peking Union Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ning-Ning Lu, Dr.
        • Principal Investigator:
          • Sheng-Ji Yu, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preoperative moderately fractionated RT with Fluzoparib

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.
Drug: Fluzoparib
One week before RT onset, during radiotherapy and 5 weeks post-RT, patients also take oral Fluzoparib (100mg, BID, five days per week).
Other Names:
  • RT+Fluzoparib
Radiation: Preoperative moderately fractionated radiotherapay
Patients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr).
Other Names:
  • RT
Experimental: Preoperative moderately fractionated RT without Fluzoparib

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.
Radiation: Preoperative moderately fractionated radiotherapay
Patients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr).
Other Names:
  • RT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major wound complications
Time Frame: 4-months post-surgery
Number of Participants with Major wound complications 4 months post-surgery
4-months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute toxicities
Time Frame: pre-IMRT, weekly during IMRT, at the end of IMRT, 1 months post-IMRT
acute toxicities were evaluated as per CTCAE V5.0 criteria weekly during IMRT and 1 months after IMRT
pre-IMRT, weekly during IMRT, at the end of IMRT, 1 months post-IMRT
Late toxicities
Time Frame: 6 months, 9 months, 12 months, 18 months and 24 months after surgery
late toxicities were evaluted as per CTCAE V5.0 criteria and RTOG scale after 6 months
6 months, 9 months, 12 months, 18 months and 24 months after surgery
Quality of Life
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
EORTC QLQ-C30 questionnaire
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
Extremity function
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
MSTS questionnaire, TESS questionnaire
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
Pathological complete remission rate
Time Frame: 2 weeks after surgery
No residual tumor cells were observed on post-operative specimens
2 weeks after surgery
2-year overall survival
Time Frame: 2 year since enrollment
Incidence of participants who were alive
2 year since enrollment
2-year local control
Time Frame: 2 year since enrollment
Incidence of participants who had no Local relapse
2 year since enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Beijing Jishuitan Hospital

Investigators

  • Principal Investigator: Ning-Ning Lu, Dr., Cancer Hospital and Institute, National Cancer Center, CAMS& PUMC, Beijing, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 21, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 10, 2023

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC-4016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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