Status:
RECRUITING
Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma (FUSION-01)
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Soft Tissue Sarcoma
Retroperitoneal Sarcoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy followed by surgery for retroperitoneal sarcoma
Eligibility Criteria
Inclusion
- 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
- metastatic disease
- Tumor was previously treated by radiotherapy
- Involvement of liver, pancreatic head or duodenum
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05224934
Start Date
January 1 2022
End Date
December 31 2027
Last Update
December 11 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021