Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma (FUSION-01)

Recruiting now · Not applicable

Conditions studied: Soft Tissue Sarcoma, Retroperitoneal Sarcoma, Radiotherapy Side Effect, Ultra-hypofractionated Radiotherapy, Stereotactic Ablative Radiotherapy

In brief

To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy followed by surgery for retroperitoneal sarcoma

Key facts

Study ID

NCT05224934

Run by

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

People needed

50

Starts

2022-01-01

Expected to finish

2027-12-31

Last updated by the study team

2025-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• metastatic disease
• Tumor was previously treated by radiotherapy
• Involvement of liver, pancreatic head or duodenum

Where it is running

• Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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