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Completed

NCT Number: NCT05938374

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Jishuitan Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: RT+Fluzoparib

Preoperative moderately fractionated radiotherapay

Radiation

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

Other names: RT

Primary outcomes

  1. Major wound complications

    Time frame: 4-months post-surgery

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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Pathological complete remission rate

    Time frame: 2 weeks after surgery

    No residual tumor cells were observed on post-operative specimens

  6. 2-year overall survival

    Time frame: 2 year since enrollment

    Incidence of participants who were alive

  7. 2-year local control

    Time frame: 2 year since enrollment

    Incidence of participants who had no Local relapse

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Collaborators

  • Beijing Jishuitan Hospital

Registry information

Official study title

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

Acronym: SPARE-03

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2023
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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