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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
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase
Not applicable
Started
2022-01-01
Last updated
2025-12-11

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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)

Trial sites (1)

FacilityCityRegionStatus
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

Other trials for the same condition

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