Preoperative Moderately Fractionated IMRT for Locally Extremity or Trunk Sarcoma (SPARE-03) (SPARE-03)

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: Completed
• Conditions: Soft Tissue Sarcoma
• Intervention / Treatment: Drug: Fluzoparib; Radiation: Preoperative moderately fractionated radiotherapay

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 (Actual): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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	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	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	No residual tumor cells were observed on post-operative specimens	2 weeks after surgery
2-year overall survival	Incidence of participants who were alive	2 year since enrollment
2-year local control	Incidence of participants who had no Local relapse	2 year since enrollment

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

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): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: PARP inhibitor; Complications; soft tissue sarcoma; preoperative radiotherapy; moderately fractionated RT
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Sarcoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Poly(ADP-ribose) Polymerase Inhibitors; fluzoparib
• 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