Clinical trial · Interventional
Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma (FUSION-01)
Full-target Ultra-hypofractionated Stereotactic Irradiation Orchestrated With Nodule Boost for Retroperitoneal Sarcoma
NCT05224934CI-TRIAL-00098780FUSION-01recruitingN/AClinicalTrials.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 feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy followed by surgery for retroperitoneal sarcoma
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiotherapy Side Effect | — | UNRESOLVED | — |
| Retroperitoneal Sarcoma | Retroperitoneal Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
| Stereotactic Ablative Radiotherapy | — | UNRESOLVED | — |
| Ultra-hypofractionated Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ultra-hypofractionated radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ultra-hypofractionated radiotherapy
- description
- Patients receive ultra-hypo-fractionated radiotherapy with 25Gy to 50Gy in five fractions, followed by surgery done at 1 to 2 months post-RT
- interventionNames
- Radiation: ultra-hypofractionated radiotherapy
Primary outcomes (1)
- measure
- Peri-operative complications
- timeFrame
- From surgery date up to 7 days later
- description
- The proportion of patients who suffer from
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Primary soft tissue sarcoma of retroperitoneal or infra-peritoneal spaces of pelvis * Sarcoma not originated from bone structure, abdominal or gynecological viscera * All disease can be included safely within one radiotherapy field * Absence of extension through the sciatic notch or across the diaphragm * Histologically proven, excluding the following subtypes: Gastro-intestinal stromal tumors (GIST), rhabdomyosarcoma, PNET or other small round blue cells sarcoma, osteosarcoma or chondrosarcoma, aggressive fibromatosis, sarcomatoid or metastatic carcinoma * ECOG performance status 0 to 2 * American Society of Anesthesiologist (ASA) score ≤2 * Normal renal function: Calculated Creatinine Clearance ≥50ml/min（by Cockcroft-Gault formula）and functional contralateral kidney by differential renal isotope scan * Normal bone marrow and hepatic function. * Contraception was needed for female patients of child-bearing age, or male patients whose partner had child-bearing age * expected life expectancy longer than 5 years * Written consent form was given prior to treatment * Can safely be treated by radiotherapy and surgery Exclusion Criteria: * metastatic disease * Tumor was previously treated by radiotherapy * Involvement of liver, pancreatic head or duodenum
References
Publications (0)
Data not yet available
No reference posted for this study.