Clinical Trials in China / NCT05224934
Recruiting
Not applicable
Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma (FUSION-01)
NCT05224934 · tracked via the Priya Life Science China tracker
Condition(s) studied
Soft Tissue SarcomaRetroperitoneal SarcomaRadiotherapy Side EffectUltra-hypofractionated RadiotherapyStereotactic Ablative Radiotherapy
Investigational drug(s) / intervention(s)
ultra-hypofractionated radiotherapy
ultra-hypofractionated radiotherapy: stereotactic ablative radiotherapy with 25 to 50Gy in five fractions given preoperatively
Study summary
To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy followed by surgery for retroperitoneal sarcoma
Eligibility
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
Primary outcome measure(s)
- Peri-operative complications — From surgery date up to 7 days later
The proportion of patients who suffer from
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | Recruiting |
More Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials in China
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05224934 on ClinicalTrials.gov ↗ ← All trials in China