Clinical trial · Interventional
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
NCT05938374CI-TRIAL-00098790SPARE-03completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate the safety and efficacy of preoperative moderately fractionated IMRT and concurrent Fluzoparib Hydrochloride for primary truncal or extremity soft tissue sarcoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluzoparib | Drug | — | UNRESOLVED |
| Preoperative moderately fractionated radiotherapay | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Preoperative moderately fractionated RT with Fluzoparib
- description
- 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.
- interventionNames
- Drug: Fluzoparib
- Radiation: Preoperative moderately fractionated radiotherapay
- type
- EXPERIMENTAL
- label
- Preoperative moderately fractionated RT without Fluzoparib
- description
- 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.
- interventionNames
- Radiation: Preoperative moderately fractionated radiotherapay
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.