Actively Recruiting
Full-target Ultra-hypofractionated Stereotactic Irradiation Orchestrated With Nodule Boost for Retroperitoneal Sarcoma
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-12-11
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility and peri-operative complications of preoperative ultra-hypofractionated radiotherapy followed by surgery in patients with retroperitoneal sarcoma, a type of soft tissue cancer located in the retroperitoneal or infra-peritoneal pelvic spaces. The study aims to understand how this treatment approach may impact surgical outcomes and complications shortly after surgery. Participants will receive ultra-hypofractionated stereotactic ablative radiotherapy, delivering a total dose of 25 to 50 Gy in five fractions before surgery. Surgery is then performed one to two months after completing the radiotherapy. This approach focuses radiation on the tumor area safely included within one radiotherapy field, avoiding involvement of critical nearby structures. During the study, participants will be closely monitored for complications from surgery up to seven days post-operation. Researchers will assess peri-operative safety and treatment feasibility. Participants must have normal kidney, bone marrow, and liver function and meet certain health and performance status criteria. The overall study duration includes radiotherapy, surgery, and the immediate postoperative monitoring period.
CONDITIONS
Brief Title
Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma (FUSION-01)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 sarcoma excluding GIST, rhabdomyosarcoma, PNET, osteosarcoma, chondrosarcoma, aggressive fibromatosis, sarcomatoid or metastatic carcinoma
- ECOG performance status 0 to 2
- American Society of Anesthesiologist (ASA) score ≤2
- Normal renal function with creatinine clearance ≥50 ml/min and functional contralateral kidney
- Normal bone marrow and hepatic function
- Contraception required for females of child-bearing age or males with partners of child-bearing age
- Expected life expectancy longer than 5 years
- Written consent provided prior to treatment
- Able to safely receive radiotherapy and surgery
You will not qualify if you...
- Metastatic disease
- Tumor previously treated by radiotherapy
- Involvement of liver, pancreatic head or duodenum
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 fractions over approximately 1 week
Participants receive ultra-hypofractionated stereotactic radiotherapy with 25Gy to 50Gy in five fractions before surgery.
5 visits (in-person) for radiotherapy sessions
Duration - 1 day for surgery
Participants undergo surgery 1 to 2 months after completing radiotherapy.
1 visit (in-person) for surgery
Duration - 7 days
Participants are monitored for peri-operative complications up to 7 days after surgery.
Daily visits or assessments during the 7-day post-operative period
Trial Site Locations
Total: 1 location
1
Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
N
Ning-Ning Lu
S
Shu-Lian Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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