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

NCT05938374 | Completed Phase 2 DMC

• 1 other identifier: NCC-4016
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

Soft Tissue Sarcoma

Keywords

soft tissue sarcoma; preoperative radiotherapy; moderately fractionated RT; Complications; PARP inhibitor

Outcome Measures

Primary Outcomes (1)

• Major wound complications

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

  4-months post-surgery

Secondary Outcomes (7)

• Acute toxicities

  pre-IMRT, weekly during IMRT, at the end of IMRT, 1 months post-IMRT

• Late toxicities

  6 months, 9 months, 12 months, 18 months and 24 months after surgery

• Quality of Life

  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

  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

  2 weeks after surgery

Study Arms (2)

Preoperative moderately fractionated RT with Fluzoparib

EXPERIMENTAL

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; Radiation: Preoperative moderately fractionated radiotherapay

Preoperative moderately fractionated RT without Fluzoparib

EXPERIMENTAL

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

Interventions

Fluzoparib DRUG

One week before RT onset, during radiotherapy and 5 weeks post-RT, patients also take oral Fluzoparib (100mg, BID, five days per week).

Also known as: RT+Fluzoparib

Preoperative moderately fractionated RT with Fluzoparib

Preoperative moderately fractionated radiotherapay RADIATION

Patients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr).

Also known as: RT

Preoperative moderately fractionated RT with Fluzoparib; Preoperative moderately fractionated RT without Fluzoparib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Beijing Jishuitan Hospital: collaborator

Study Sites (2)

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, China

Location

Cancer Hospital and Institute, National Cancer Center, Chinese Academy of Medical Sciences & Peking Union Medical Center

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Sarcoma

Interventions

fluzoparib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Ning-Ning Lu, Dr.

  Cancer Hospital and Institute, National Cancer Center, CAMS& PUMC, Beijing, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Preoperative moderately fractionated RT with Fluzoparib Preoperative moderately fractionated RT without Fluzoparib

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 10, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

CN (2)