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

NCT ID: NCT05938374

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-12-31

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.

Conditions

Soft Tissue Sarcoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fluzoparib

Intervention Type: DRUG

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

Preoperative moderately fractionated radiotherapay

Intervention Type: RADIATION

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

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.

Group Type: EXPERIMENTAL

Preoperative moderately fractionated radiotherapay

Intervention Type: RADIATION

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

Interventions

Fluzoparib

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: DRUG

Preoperative moderately fractionated radiotherapay

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

Intervention Type: RADIATION

Other Intervention Names

RT+Fluzoparib; RT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Jishuitan Hospital

OTHER

Sponsor Role: collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

NINGNING LU

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ning-Ning Lu, Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, China

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

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

NCC-4016

Identifier Type: -

Identifier Source: org_study_id