NCT05938374CompletedPhase 2
Preoperative Moderately Fractionated IMRT for Locally Extremity or Trunk Sarcoma (SPARE-03)
Preoperative Moderately Fractionated Intensity-modulated Radiotherapy (IMRT) With/Without Concurrent Fluzoparil for Locally Extremity or Trunk Sarcoma
Source: ClinicalTrials.gov · Last updated 11 Dec 2025
Brief summary (registry, in English)
To investigate the safety and efficacy of preoperative moderately fractionated IMRT and concurrent Fluzoparib Hydrochloride for primary truncal or extremity soft tissue sarcoma.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 52 (actual)
- First submitted
- 21 Jun 2023
- Start date
- May 2023
- Primary completion date
- Dec 2024
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Sarcoma
- NCT number
- NCT05938374
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 52
- From May 2023 to the primary completion date, Dec 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No gross tumor post-resection in other center.
- Previous irradiation to the same area
Other illness
- 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.
- Secondary cancer within 5 years (except cervical carcinoma in situ or early-stage skin basal cell carcinoma)
Other
- Dermatofibrosarcoma protuberans(DFSP), Desmoids, etc.
- Benign histology
- STS can be cured by extensive operation alone.
- radiological evidence of distant metastases
- Other contraindications, can't tolerate operation or other treatment needed in this study.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Jishuitan Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Cancer Hospital and Institute, National Cancer Center, Chinese Academy of Medical Sciences & Peking Union Medical Center Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.